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VOLUME 10

2020

10th European Biotechnology Guide


European
Biotechnology
Guide
Science & Industry

European
ISBN 978-3-928383-75-2 Biotechnology
NET WORK
European
Biotechnology
Guide
Science & Industry
© BIOCOM AG, Berlin 2020

European Biotechnology Science & Industry Guide 2020 (Volume 10)

Published by:
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ISBN: 978-3-928383-75-2
Editorial

Nobody said it would be easy –


forward to the biologisation of the industry

These days, an industrial drama in Canada is giving us food for thought. Bombardier
is currently selling off its largest remaining division - the railway business - to its French
competitor Alsthom for around 7 billion EUR. The company is heavily in debt and this
is not the first emergency sale. Within two years the number of employees will fall from
more than 70,000 to less than 20,000. The reason for this development was a tech-
nological dream: in recent years, Bombardier designed the C-Series, the first com-
pletely newly developed commercial aircraft, and aimed to break up the Boeing/Airbus
duopoly. The extremely fuel-efficient aircraft, known as the Whisper Jet, was a great
success both technically and aesthetically, but Boeing in particular was hindering
market access, especially in North America. In addition, development costs ran out
of control at almost 6 billion EUR. The company, controlled by the Bombardier family,
had put all its eggs in one basket and lost despite a great product: the aircraft is now
called the Airbus A220 and sells very well.
Andreas Mietzsch
What does this have to do with biotechnology? Biotechnology has become established European Biotechnology
in the pharmaceutical industry, more than half of all newly approved drugs are based Network, Brussels
on it. But the big conglomerates knew early on how to secure their market power and
let the biotechnologists work for them in small “gene boutiques”. The dream of the
early founders to establish a FIBCO (fully integrated biopharmaceutical company)
remained unfulfilled, at least in Europe. As a cross-sectional technology, biotechnol-
ogy tends to grow into the traditional companies. In the case of industrial biotechnol-
ogy, the situation is even worse. Not just one company like Boeing, but an entire in-
dustry is fending off biotechnological solutions: the chemical industry based on fossil
raw materials. Climate protection or not, the steam-crackers must go on. And here
we are again at Bombardier: the greatest dream and the best product are no guaran-
tee for success when market structures are petrified.

Dear readers, we must nevertheless continue and try to realise our fascinating dream
of biologising the industry. Try harder! Even the greatest empires in history once col-
lapsed and were replaced by newer, more contemporary structures. For Europe in
particular, the great diversity of entrepreneurial initiatives represents the opportunity
to make the economic area fit for the future on the basis of knowledge. It is better to
avoid too much debt, see above, but without the dreamers and makers, all that remains
is stagnation. And the planet can no longer afford this. The exclusive selection in this
book shows just how much creativity and energy there is in Europe’s biotechnological
corporate landscape. Let us inspire you! european-biotechnology.net

10th european biotechnology guide 2020 2|3


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Content

Editorial . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Indivumed GmbH . . . . . . . . . . . . . . . . . . . . . . . . . . 104


intravacc. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . 7 InVivo BioTech Services GmbH. . . . . . . . . . . . . . . . 108

Profiles. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 KAIROS GmbH . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110


3P Biopharmaceuticals S.L. . . . . . . . . . . . . . . . . . . 14
Labor Dr. Merk & Kollegen GmbH. . . . . . . . . . . . . . 112
Affimed GmbH. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Losan Pharma GmbH . . . . . . . . . . . . . . . . . . . . . . . 114
AGC Biologics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
AmpTec GmbH . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Apogenix AG. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 Merck Biodevelopment. . . . . . . . . . . . . . . . . . . . . . 116
Armbiotechnology. . . . . . . . . . . . . . . . . . . . . . . . . . 24 Microcoat Biotechnologie GmbH . . . . . . . . . . . . . . 118
ASEBIO. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 Microsynth AG. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120
Axolabs GmbH . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 Molzym GmbH & Co. KG. . . . . . . . . . . . . . . . . . . . . 122
MyData-TRUST. . . . . . . . . . . . . . . . . . . . . . . . . . . . 124
Biaffin GmbH & Co KG . . . . . . . . . . . . . . . . . . . . . . 30
BIO.NRW. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 New England Biolabs GmbH. . . . . . . . . . . . . . . . . . 126
BIOCOM AG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 Novaliq GmbH. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128
Bioengineering AG. . . . . . . . . . . . . . . . . . . . . . . . . 36 NSF Health Sciences Ltd.. . . . . . . . . . . . . . . . . . . . 130
BIOFABRI S.L.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Biological Industries (BI) Ltd.. . . . . . . . . . . . . . . . . . 40 OP2 Drugs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132
BioNukleo GmbH. . . . . . . . . . . . . . . . . . . . . . . . . . 42 OPIS s.r.l.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134
BIOTECON Diagnostics GmbH. . . . . . . . . . . . . . . . 44
Black Swan Analysis. . . . . . . . . . . . . . . . . . . . . . . . 46 PeproTech EC Ltd. . . . . . . . . . . . . . . . . . . . . . . . . . 136
Boehringer Ingelheim . . . . . . . . . . . . . . . . . . . . . . . 48 polpharma biologics . . . . . . . . . . . . . . . . . . . . . . . . 138
ProBioGen AG. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140
Campania Bioscience. . . . . . . . . . . . . . . . . . . . . . . 50
CBT China Bioengineering Technology. . . . . . . . . . 52
Recipharm AB . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142
Cellex CMT GmbH. . . . . . . . . . . . . . . . . . . . . . . . . 54
Redx Pharma plc. . . . . . . . . . . . . . . . . . . . . . . . . . . 144
CellGenix GmbH. . . . . . . . . . . . . . . . . . . . . . . . . . . 56
CILcare . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58 Rentschler Biopharma SE. . . . . . . . . . . . . . . . . . . . 146
Cobra Biologics. . . . . . . . . . . . . . . . . . . . . . . . . . . . 60 RheinCell Therapeutics GmbH . . . . . . . . . . . . . . . . 148
CRS Clinical Research Services Andernach. . . . . . 62 Richter-Helm BioLogics GmbH & Co. KG. . . . . . . . 150
Roche Diagnostics GmbH. . . . . . . . . . . . . . . . . . . . 152
Enantis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64 Roto Inox d.o.o.. . . . . . . . . . . . . . . . . . . . . . . . . . . . 154
Enzymicals AG. . . . . . . . . . . . . . . . . . . . . . . . . . . . 66 Rottapharm Biotech S.r.l. . . . . . . . . . . . . . . . . . . . . 156
EphyX Neuroscience. . . . . . . . . . . . . . . . . . . . . . . . 68
ERBC Group. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70 SOCOREX ISBA SA. . . . . . . . . . . . . . . . . . . . . . . . . 158
Eurasanté . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72 Swiss Biotech Association SBA . . . . . . . . . . . . . . . 160
Eurofins BioPharma Product Testing Munich. . . . . 74
EuroJobsites Ltd. . . . . . . . . . . . . . . . . . . . . . . . . . . 76 Taconic Biosciences. . . . . . . . . . . . . . . . . . . . . . . . 162
Euronext Paris S.A.. . . . . . . . . . . . . . . . . . . . . . . . . 78 Talk Biotech Limited . . . . . . . . . . . . . . . . . . . . . . . . 164
Evotec AG. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80 Technologiepark Heidelberg. . . . . . . . . . . . . . . . . . 166
Tigermed Co., Ltd.. . . . . . . . . . . . . . . . . . . . . . . . . . 168
FGK Clinical Research GmbH. . . . . . . . . . . . . . . . . 82 Tissue Solutions Ltd . . . . . . . . . . . . . . . . . . . . . . . . 170
FILTROX AG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84 Tosoh Bioscience . . . . . . . . . . . . . . . . . . . . . . . . . . 172
Fördergesellschaft IZB . . . . . . . . . . . . . . . . . . . . . . 86
TRIGA-S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 174
Fraunhofer ITEM. . . . . . . . . . . . . . . . . . . . . . . . . . . 88
Fundación MEDINA. . . . . . . . . . . . . . . . . . . . . . . . . 90
UGA Biopharma GmbH. . . . . . . . . . . . . . . . . . . . . . 176
GenScript Biotech (Netherlands) B.V.. . . . . . . . . . . 92
GETEC PARK.SWISS AG . . . . . . . . . . . . . . . . . . . . 94 VAXIMM GmbH. . . . . . . . . . . . . . . . . . . . . . . . . . . . 178
glyXera GmbH. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96 Vetter Pharma International GmbH. . . . . . . . . . . . . 180
Hezelburcht B.V. . . . . . . . . . . . . . . . . . . . . . . . . . . . 98 Vibalogics GmbH. . . . . . . . . . . . . . . . . . . . . . . . . . . 182
Vivoryon Therapeutics AG. . . . . . . . . . . . . . . . . . . . 184
IBA GmbH. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100
Immunic AG. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102 YUMAB GmbH . . . . . . . . . . . . . . . . . . . . . . . . . . . . 186

10th european biotechnology guide 2020 4|5


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or contact Dr. Boris Mannhardt at b.mannhardt@biocom.de

Picture: rakchai/fotolia.com
Introduction

10th european biotechnology guide 2020 6|7


New initiatives to put Biotechnology
back in the spotlight

Despite the threat of a looming climate catastrophe, low ucts, a pan-European online job market for biotechnol-
oil prices and giant industrial conglomerates addicted ogy and life sciences, and a biotechnological climate
to fossil resources continue to stifle industrial biotech- protection project with CO2 compensation opportuni-
nology products and innovation. The European Biotech- ties.
nology Network is now providing a foot up for compa-
nies that want to help themselves by launching three “The urgent need to reinvent the global economy calls
very different projects aimed at pushing the bioecono- for completely new, sustainable, technological solu-
my forward. tions. It is unacceptable that biotechnology, which is
closely linked to natural cycles, has been completely
The European Biotechnology Network is a non-profit sidelined as a promising alternative,” says Andreas
organisation based in Brussels that was founded in Mietzsch, the Network’s acting Managing Director, who
2008 and now has around 2,000 members from every is an old hand in the scene and also the publisher of
country in Europe. Among them smaller countries such European Biotechnology. He finds it hard to believe that
as Iceland, Moldavia or Luxembourg. Larger countries biotech, which has been celebrated as an upcoming
like Germany and Britain count hundreds of members. technology for decades, is nowadays largely ignored by
For years, the network – which is staffed solely by vol- politicians, industry and society as an industry sector
unteers – was mainly dedicated to grouping interna- that is able to offer important, desperately needed al-
tional research consortia. This has changed in the past ternatives for the future. Some products that are ready
two years. for market, Mietzsch says, simply don’t get the support
they deserve.
Three new projects the network recently launched are
aimed at addressing gaps in the industry and, above all, New biotech branding
sharpening the focus on the economic role biotechnol- A classic example of the shadowy role biotechnology
ogy plays. They include a biotech label for B2C prod- plays in daily life is a ubiquitous product – laundry deter-

Picture: Manatjosef/Freepik.com
gent. For decades, biotechnologically produced enzymes These goals are defined and may be complemented by
have ensured laundry comes out of the machine clean others, such as a product’s:
even when washed at low temperatures. Amylases in
them break down starch, lipases break down fats, pro- 1. New characteristics
teases break down proteins and cellulases break down 2.  Positive impact on sustainability, biodiversity, health
cellulose to reduce the roughness of cotton textiles. or social conditions
Compared to the pre-biotech world, when laundry had to 3. C ompostability or biodegradability under normal
be washed at much higher temperatures, this saves a conditions
huge amount of energy, and is much more environmen-
tally friendly in terms of wastewater as well. The problem Partial solutions, in particular, are excluded from the
is that even today, not a single manufacturer dares to print label. A plastic bottle made with 25% bioplastic may
‘Biotech inside!’ on its label. After the long-standing de- have a slightly improved ecological balance due to the
bate about genetic engineering in agriculture, the term renewable raw materials used in its manufacture, but
remains one with associations that are less than positive because it remains a plastic bottle that could poten-
for the European public. tially persist as waste in an ocean for centuries, it will
not be approved to carry the label.
The European Biotechnology Network now wants to
change that, and has developed a biotech label that Pure substitution solutions with a view to sustainability,
manufacturers can proudly print or stick on their prod- such as a bicycle made of wood or bamboo, will also
ucts. The subtitles “Nature based” and “Bioscience for be barred, because they lack a biotechnological aspect.
life” are intended to signal to consumers at a glance what A good candidate for the label, on the other hand, would
this means. In addition, there is an individual subline that for example be an environmentally friendly rust re-
informs potential buyers about the particular benefits or mover based on bacterial siderophores, which would
advantages of this product compared to conventional be innovative and far superior to toxic chemical com-
competing products that may be on the shelf next to petitors. The Network’s new biotech label is intended
it. to identify exactly these kinds of genuine high-tech
products.
To be allowed to use the label, manufacturers will have
to meet stringent conditions. Consumers shouldn’t be Each individual product candidate for the label will be
deterred by ‘greenwashing’ – the misuse that is often closely evaluated by a top-notch group of experts at the
associated with eco or sustainability certificates. Above European Biotechnology Network. How much work they
all, the label must: will have will depend largely on the innovative abilities
and commitment of the companies pursuing new ideas.
1. Showcase the main characteristics of the product According to Mietzsch, there are not yet that many real
2. Communicate a positive message, and biotech products available to European consumers. “It’s
3.  Not celebrate intermediate stages, but real . . . . . . always the same shortcoming. We’re strong in research,
solutions. but have a problem transferring our results into market
success,” he says. “But without tangible products in
The technology must be unambiguous, which means hand, politicians and financiers will also find it difficult
it is: to enlist biotechnology to solve the major problems of
our era.”
1. Knowledge-based
2. Has a molecular basis/technology The two other new projects of the network also aim to
3. Purposive biological process integrate biotechnology into everyday life.

10th european biotechnology guide 2020 8|9


An effective biotech job market
There are many online job markets, but those that target The initiators of the new job exchange are of course
specific groups in certain industries can hold their own aware that its success will depend not only on the qual-
even against the biggest platforms. The new job market ity of candidate that appears on it, but also its critical
eurobiotechjobs.net is based on a strategic, pan-Euro- mass. The Network is therefore cooperating with other
pean idea. More than 500 million people live in the EU, job portals to bundle as many ads as possible from
Norway and Switzerland, making it the second largest Europe on the new platform. In the beginning, the tools
economic area on the planet. While full employment can available will be simple and straightforward, with more
be found in some core countries, unemployment in service functions added bit by bit. Even the longest
others remains far too high, especially among young journey begins with a first step.
people, even if they are highly qualified. Meanwhile, in
full-employment countries, a lack of well-trained em- The Climate Protection Project
ployees can pose one of the biggest obstacles to The new Biospheria Project of the European Biotech-
growth. nology Network was inspired by Laura Griestop and
the airline Lufthansa. “Laura is our sustainability ex-
“The current perception of migration and refugees pert in the network. Her constant reminders to review
completely overshadows the fact that the mobility of our own behaviour laid the groundwork for our climate
young, well-trained people is one of the absolute ad- protection initiative,” says Mietzsch. This was trig-
vantages of a common economic area,” explains Dr. gered by Lufthansa, which last year launched its own
Hans-Christian Stolzenberg, member of the Executive CO 2 compensation scheme (Compensaid) for pas-
Board of the European Biotechnology Network. “At least sengers. It allows environmentally conscious custom-
in the field of life sciences, we want to provide fast and ers to pay a surcharge that finances the use of Sus-
comprehensive information to help bring employers and tainable Aviation Fuel (SAF). A few years ago, Lufthan-
Picture: Asier_Relampagoestudio - Freepik.com

job-seekers together across national and linguistic sa was one of the first pioneering companies to get
borders.” This also includes neighbouring countries on board with SAF when it tested the use of biotech-
outside the European Union’s borders, of course. nologically-produced algae kerosene in regular serv-
Highly qualified applicants will discover that while it ice and found it to work without any problems (see
might be a little more difficult to get a job in the EU than European Biotechnology 4/2015). But what does the
for people from member states, it’s far from impossi- airline fuel its jets with today? SAF derived from used
ble. cooking oil …
This was the final impetus for the Biospheria idea – a The new strategy
CO 2 compensation programme that puts donated With its three new projects, the European Biotechnol-
money into the development of sustainable and CO2- ogy Network – which by the way is Association Partner
saving biotechnologies such as algae carbon capture. of the European Biotechnology Science and Industry Guide
Growing algae biomass fixes carbon in fat molecules. – wants to help put biotech back in the spotlight as a
This algae oil can be converted into stable carbon fibres solution to the major environmental problems of our
– thus permanently fixing CO 2. Carbon fibres are a time. And as a non-profit organisation, it may find it
sought-after building material that can be used, for easier to accomplish that goal than commercial provid-
example, as non-corrosive armouring for concrete. And ers.
at the end of its technical lifetime, the carbon can eas-
ily be deposited in former coal mines, returning CO2 set It remains to be seen whether and to what extent the
free by burned fossil fuels to the ground. The basic biotech industry will take up the offers. While biophar-
research has been completed. Now all that is lacking is maceuticals have been accepted for decades and
the money to set up industrial production in the promis- successfully marketed generally by multinational phar-
ing country of Spain. maceutical companies, the area of industrial bio-
technology continues to face powerful opponents in
For the Network team, the Biospheria project high- the form of ‘Goliath’ companies that refuse to use
lighted a major issue – that it’s quite difficult to find bio- sustainable alternatives to fossil resources. Not every
technological approaches to the CO2 problem that are entrepreneur or manager is a born ‘David’, and there
worthy of funding. Griestop recommends an interim are plenty of small, fine, B2B niches out there. That
solution. “Until we get things up and running, we’re said, however, biotechnologists have been promising
planting and cultivating trees – here and now in Europe, an industrial revolution for decades, and the climate
where we’re familiar with the area,” she says. “CO 2 clock is ticking. At five until midnight, the question begs
compensation is reviled by some as a new form of me- asking: “When, if not now?”
dieval indulgence trading. Our response to that is – so
what? It’s still better than doing nothing!” Bernardo Glavo

The
Biospheria
Picture: Dmitry Ersler/stock.adobe.com

Project
10th european biotechnology guide 2020 10 | 11
Video
Production
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Profiles

10th european biotechnology guide 2020 12 | 13


Name · 3P Biopharmaceuticals Company profile
3P Biopharmaceuticals is a Contract Development and
Address/P.O. Box ·
Pol. Mocholí. C/Mocholí 2. Manufacturing Organisation (CDMO) specialised in proc-
Postal Code/City ·
31110 Noáin (Navarra) ess development and GMP manufacturing of biologics
Country ·
Spain and cell therapy products using microbial and mamma-
Contact Person ·
Elena Erroba lian-based expression technologies.
(Director of Business Development) 3P Biopharmaceuticals is a robust manufacturing part-
Telephone · +34-948-34-64-80 ner with a successful track record on a global scale and
Email · businessdevelopment@3pbio.com a highly qualified team that accompanies clients through
Website · www.3pbio.com the full life cycle of their products: from cell line develop-
Social Media · L I ment to clinical and commercial manufacturing.
Number of Employees · 280+ In its state-of-the-art biomanufacturing facilities, the
Founded (year) · 2007 company also offers a comprehensive range of in-house
analytical and development services as well as continu-
Areas of Activity · | B
 iotechnology ous regulatory support that improves the value of its
|B iomedicine client’s drug candidates.
|C DMO
|O ne-Stop Shop GMP certified
|B iologics 3P Biopharmaceuticals offers GMP manufacturing
|G MP services for biologics.
|R ecombinant Proteins
|C ell Therapy GMP certified & FDA approved for:
·· API manufacturing (clinical trials & commercial pro-
duction)
·· QC and release of API and final products for clinical
trials and commercial phases

Highest Quality Standards


3P ensures the highest level of quality excellence and
utmost compliance with regulatory requirements.

Summary services
·· Cell line development and GMP cell banking
·· Process development and optimization
·· Analytical methods development, qualification &
validation
·· Scale-up and cGMP manufacturing
·· DS & DP release
·· Process characterisation & validation
·· Commercial manufacturing
·· Tech transfer
3P Biopharmaceuticals

Advanced therapies
·· Cell therapy products
·· Tissue-engineered products
·· Cell culture media
·· Biomaterials (scaffolds or membranes)

Biologics facilities & equipment


Process development capacities for mammalian:
·· Bioreactor ambr ® 250
·· Microbioreactor ambr ®, 24 vessels
·· Biostat Q 6x1L
·· Biostat B 2x2L+1x5L
·· Biostat B twin 2x5L

Process development capacities for microbial:


·· Biostat B twin 2x2L +2x2L
·· Biostat B DCU 2x2L + 2x10L
·· Biostat C 1x10L

GMP Manufacturing capacities for mammalian:


·· Single use bioreactors: 50L, 200L, 400L, 2000L

GMP Manufacturing capacities for microbial:


·· Stainless steel bioreactors: 2x10L, 2x100L, 1000L

Track record
3P has been involved in GMP manufacturing projects
starting from gene design up to commercial manufactur-
ing, including technology transfers from several CMOs
based in Europe and the United States. 3P Biopharma-
ceuticals is capable of working with various expression
systems: microbial and mammalian. Moreover, the com-
pany has extensive experience in process development
and GMP manufacturing of New Biological Entities (NBEs),
including fusion proteins, vaccines, monoclonal antibod-
ies, and Fabs. The 3P Biopharmaceuticals team is also
highly skilled and specialised in biosimilar development.
The company has a proven approach for the execution of
risk assessments, scale-down model validation, and proc-
ess characterisation to facilitate successful process vali-
dation and market supply. 3P biopharmaceuticals delivers
a broad and profound knowledge of biologics and its goal
is to exceed clients’ expectations while providing tailored
and effective solutions that will ensure project success.

10th european biotechnology guide 2020 14 | 15


Name · Affimed Affimed –
engaging innate cells to fight cancer
Address/P.O. Box · Im Neuenheimer Feld 582 Affimed (Nasdaq: AFMD) engineers target immuno-
Postal Code/City · 68120 Heidelberg therapies, seeking to cure patients by giving them back
Country · Germany their innate ability to fight cancer. We are developing
Contact Person · Dr Angela Sickmann single and combination therapies to treat hematologic
Telephone · +49-6221-6743672 and solid tumours.
Fax · +49-6221-6743649
Email · a.sickmann@affimed.com Our approach
Website · www.affimed.com Although the human immune system is normally capable
Number of Employees · 96 of recognising foreign or aberrant cells, cancer cells have
Founded (year) · 2000 acquired highly effective ways to escape immune surveil-
lance. As a result, immune cells such as NK cells and mac-
Areas of Activity · Immuno-Oncology rophages, which are part of the innate immune system
(the first line of defence) cannot recognise tumour cells as
External · l Genentech foreign or aberrant and therefore cannot fight them.
Collaborations l Leukemia and Lymphoma Society
l MSD (Merck & Co.) To overcome these limitations, we develop antibodies
l MD Anderson Cancer Center that activate innate immune cells and redirect them to the
tumour, thereby disabling the tumour’s evasion mecha-
nisms. They establish a bridge between either NK cells
or macrophages and cancer cells, triggering an immune
response that leads to the destruction of tumour cells.

Our ROCK® platform


Leveraging our modular and versatile ROCK® (Redirected
Optimised Cell Killing) platform, we generate proprietary,
next-generation multi-specific antibodies. Our tetravalent
(four binding sites), bispecific (two targets) innate cell en-
gagers (ICEs) have the ability to bring NK cells or macro-
phages into proximity to cancer cells and trigger a signal
cascade that leads to the destruction of these cancer
cells. A number of clinical and preclinical programmes
are in development based on the ROCK® platform and
our ICEs have already shown a favourable safety profile
and promising signs of therapeutic efficacy.

Our modular ROCK® platform with its versatile features


enables the generation of multi-specific antibodies with
appropriate properties for tailored treatment including
half-life, tissue distribution, and optimal tumour and
immune cell targeting. This allows us to tailor our im-
mune cell engagers to specific indications and patient
settings.
!"#"$%&
Targeted !"#"$%&
tumour cell killing
!"#"$%&via immune cell engagement
!""#$%&'%((&%$)*)%+&
&
&
!""#$%&'%((&%$)*)%+&
&
&
!""#$%&,*+)%,&
&
Affimed
!""#$%&'%((&%$)*)%+& !""#$%&,*+)%,& &
Innate
&
cell engager Innate
&
cell target Tumour target
-#".#+&,*+)%,&
& &
!""#$%&,*+)%,& -#".#+&,*+)%,&
&
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-#".#+&,*+)%,&

innate Our product candidates


Tumour
cell AFM13
Innate cell target: CD16A
Tumour target:   CD30

Engager Therapy AFM13 is our lead product candidate and engages NK


cells and macrophages. It is designed to treat CD30-
positive malignancies including Hodgkin’s lymphoma
(HL), and cutaneous and peripheral T-cell lymphoma
(CTCL, PTCL). It is being investigated in HL as mono-
therapy (Phase 2a) and in cutaneous T-cell lymphoma
(CTCL, Phase 1b/2a). A registration-directed Phase 2
study (REDIRECT) with AFM13 as monotherapy in re-
lapsed or refractory patients with CD30-positive T-cell
lymphoma or transformed mycosis is ongoing.
In addition, AFM13 is being investigated in combina-
tion studies, e.g. with Merck’s checkpoint inhibitor
Immunological Synapse KEYTRUDA® and with adoptive NK cells.

AFM24
Innate cell target: CD16A
Tumour target:   EGFRwt

AFM24 binds to the EGFR wild-type, which is con-


stitutively active in some solid tumors. AFM24 has
demonstrated the killing of tumour cells independent
of their mutational status (e.g. Ras) and has completed
preclinical development. A Phase 1/2a study with AFM24
Release of Perforins and Granzymes as monotherapy has recently been initiated.

AFM26 (partnered programme)


NK cell target: CD16A
Tumour target: BCMA

AFM26 binds to B-cell maturation antigen (BCMA), an


attractive target due to its limited expression on healthy
tissues and almost universal expression on multiple
myeloma cells in the majority of patients. AFM26 is in
preclinical development.

AFM28 and AFM32


Tumour target: Undisclosed
Tumour Cell Lysis
AFM28 and AFM32 are currently in preclinical development.

10th european biotechnology guide 2020 16 | 17


Name · AGC Biologics GmbH AGC Biologics is a leading global Contract Develop-
ment and Manufacturing Organisation (CDMO), with a
Address/P.O. Box · Czernyring 22 strong commitment to delivering the highest standard
Postal Code/City · 69115 Heidelberg of service to our clients and partners. AGC Biologics is
Country · Germany the product of the convergence and integration of AGC
Contact Person · Dieter Kramer (Managing Director) Bioscience, Biomeva GmbH, and CMC Biologics. The
Telephone · +49-6221-90260 company currently employs more than 850 employees
Fax · +49-6221-902690 worldwide. Our extensive network spans three conti-
nents, with cGMP-compliant facilities in Seattle, WA,
Affiliate: USA; Copenhagen, Denmark; Heidelberg, Germany;
Name · AGC Biologics A/S and Chiba, Japan.
Address/P.O. Box · Vandtaarnsvej 83B
Postal Code/City · 2860 Soeborg AGC Biologics offers deep industry expertise and unique
Country · Denmark customised services for the scale-up and cGMP manu-
Contact Person · J.D. Mowery (Managing Director) facture of biologics and protein-based therapeutics: from
preclinical to commercial production with both mam-
Email Address · contact@agcbio.com malian and microbial platforms. Our integrated service
Internet Website · www.agcbio.com offerings include cell line development, bioprocess devel-
Number of Employees · >850 opment, formulation, analytical testing, antibody drug de-
Type of Laboratory · S1, GMP velopment and conjugation, cell banking and storage, and
protein expression — including our proprietary CHEF1®
Areas of Activity · | Contract manufacturing of Expression System for mammalian production.
biopharmaceuticals
| Process development Copenhagen & Heidelberg facilities
| Microbial fermentation and European Manufacturing Capacity
mammalian cell culture With state-of-the-art clinical and commercial manufac-
| Plasmid DNA production turing facilities across the United States, Europe, and
(pDNA services) Asia, AGC Biologics has the capacity and flexibility to
| Microbial cell banking meet each customer’s individual manufacturing needs.
| Bioanalytical services Our manufacturing facilities are multi-process, engi-
neered for unidirectional flow, and segregated to produce
External · AGC Biologics clinical and commercial multiple products at different stages of manufacturing in
Collaborations manufacturing sites in Japan (Chiba), multiple parts of the facility. This increases the flexibility
USA (Seattle), and Denmark (Copenhagen) and number of manufacturing solutions available to meet
clients’ rigorous manufacturing needs.

AGC Biologics operates multiple cGMP manufacturing


lines and a variety of scales in our facilities in Heidel-
berg, Germany and Copenhagen, Denmark. The uni-
flow design allows for capacity and technological flex-
ibility, while ensuring compliance with current guidelines
required for cGMP compliance. Whatever the challenge,
AGC Biologics is your solution for clinical and commer-
cial manufacturing.
agc biologics

Microbial Facility Equipment


Microbial cell banking and storage
·· Master cell banks and working cell banks
·· Production, characterisation, and storage

Process development
·· Upstream development
·· Downstream development
·· Analytical development

Microbial manufacturing capabilities


·· Production of therapeutic proteins and DNA plasmids
(pDNA)
·· Stainless steel fermenters with working volumes of
10L, 100L, and 1000L
·· Continuous centrifugation harvest
·· Experience with E. coli, P. pastoris, and other micro-
bial expression systems
·· Production as secreted proteins, soluble intracellular
proteins, or inclusion bodies
·· Quality control release and stability testing

Mammalian Facility Equipment


Mammalian cell banking and storage
·· Master cell banks and working cell banks
·· Production, characterisation, and storage

Process development
·· Upstream development
·· Downstream development
·· Analytical development

Mammalian manufacturing capabilities


·· Production of therapeutic proteins, monoclonal anti-
bodies, fragments, and other biologics
·· Single Use Bioreactors with working volumes of 100L,
500L, 2000L and up to 6x2000 L (6-Pack®)
·· Experience with several mammalian expression sys-
tems; facility approved commercially by EMA, FDA,
HCA, PMDA
·· Quality control release and stability testing

10th european biotechnology guide 2020 18 | 19


Name · AmpTec GmbH AmpTec GmbH, is a Hamburg, Germany based inter-
an ISO 13485:2007 Company national active contract manufacturing company (CMO)
with comprehensive services for cGMP manufactur-
Address/P.O. Box · Koenigstr. 4A ing of synthetic nucleic acids for biotech and pharma
Postal Code/City · 22767 Hamburg companies. The company was founded in May 2005
Country · Germany by Dr Guido Krupp and Dr Peter Scheinert and has a
Contact Person · Dr Peter Scheinert (CEO), proven trackrecord of almost 15 years right now.
Dr Guido Krupp (CEO) Key products are synthetic RNAs and DNAs for in vitro
Telephone · +49-40-636-747-22 diagnostics as well as fully functional mRNAs as drug
Fax · +49-40-636-747-19 substance or active pharmaceutical ingredient (API) for
Email Address · info@amp-tec.com the pharmaceutical industry using mRNAs to develop a
Internet Website · www.amp-tec.com new category of medicines.

Areas of Activity · l Contract development and


manufacturing of synthetic nucleic Regulatory history
acids (RNA & DNA) for diagnostic and ·· Manufacturer in compliance with ISO 9001 since 2008
therapeutic applications ·· Manufacturer in compliance with ISO 13485 since
l cGMP manufacturing of messenger 2010
RNA (mRNA) therapeutics for ·· Compliance with cGMP since 2012 (regulations of
preclinical-and clinical studies FDA 21 CFR Part 820)
l Process Development ·· Compliance with cGMP FDA 21 CFR Part 210 and
l Development and establishment of ICH Q7 (section 19: APIs for use in clinical trials) since
cGMP compliant customer specific 2016
QC-tests ·· In 2018: IND submission for clinical trials. FDA Clear-
ance in 2019

cGMP biomanufacturing
AmpTec provides customized solutions for each client
and offers guaranteed product quality according to
international cGMP guidelines. All AmpTec products
are produced in a highly regulated state-of-the art GMP
environment.

Products and services


Customized Long single stranded RNAs (ssRNA) and
DNAs from any sequence at at any length and scale
Key applications:
·· Reference material for the development of in vitro
diagnostic assays
·· Therapy-accompanying diagnostics (companion
diagnostics)
·· Internal controls for real time-PCR diagnostic kits
amptec

Customized Long RNA Oligos fully enzymatically pro-


duced at at any length and scale
Key applications:
·· Guide RNAs for CRISPR
·· RNA therapeutics
·· RNAi applications
·· Short RNA controls

Customized Long double-stranded RNAs (dsRNA) at


any length and scale
Key applications:
·· dsRNA as tool for gene-specific silencing of gene
expression
·· Long dsRNA is substantially more effective than short
dsRNA

Customized fully functional messenger RNAs (mRNA)


from any sequence at at any length and scale
Key applications:
·· Highly specific vaccination
·· Individualized tumor therapy with patient-specific
tumor neo-antigens
·· Cellular reprogramming
·· Genome editing
·· Protein replacement

Capabilities
AmpTec has a highly motivated team of currently 42 em-
ployees with outstanding experience in GMP-compliant
manufacturing of synthetic nucleic acids.

Experience
AmpTec offers complete customized solutions for its
customers worldwide since almost 15 years and is a
highly reliable partner for the biotechnology & pharma-
ceutical industry.
mRNA batches manufactured at AmpTec are already
used by our customers for Clinical Trials (ex vivo), Pre-
Clinical Trials (in vivo) and Clinical Trials (in patient).

AmpTec offers excellent customer contact and flexibility


to make our customer projects successful.

10th european biotechnology guide 2020 20 | 21


Name · Apogenix AG Company overview
Apogenix develops innovative immuno-oncology thera-
Address/P.O. Box · Im Neuenheimer Feld 584 peutics for the treatment of cancer and other malignant
Postal Code/City · 69120 Heidelberg diseases. The company has built a promising pipeline of
Country · Germany drug candidates that target different tumour necrosis fac-
Contact Person · Juergen Gamer, PhD tor superfamily (TNFSF)-dependent signaling pathways,
Telephone · +49-6221-58608-0 thereby restoring the anti-tumour immune response.
Fax · +49-6221-58608-10 Checkpoint inhibitor asunercept, Apogenix’s lead
Email · contact@apogenix.com immuno-oncology candidate, is being developed for the
Website · www.apogenix.com treatment of solid tumours and malignant hematological
Number of Employees · 60 diseases. Asunercept has shown a positive trend in over-
Founded (year) · 2005 all survival in a phase II trial in recurrent glioblastoma – the
Type of Laboratory · S1 most frequent and aggressive brain tumour – and has
demonstrated hematological improvements in a phase
Areas of Activity · Drug development I trial in myelodysplastic syndromes (MDS) – a stem cell
disorder that can lead to severe anaemia.
Biological Patents · Comprehensive international patent
portfolio
Lead immuno-oncology candidate
External · Strong network with numerous asunercept
Collaborations academic and industrial partners Apogenix’s lead drug candidate asunercept is a fully
human fusion protein that consists of the extracellular
Request for · Apogenix is exploring partnerships domain of the CD95 receptor and the Fc domain of an
Further Collaborations with pharmaceutical and IgG antibody. Asunercept inhibits CD95 ligand-mediated
biotechnology companies as well as signaling, which plays an important role in the progres-
collaborations with leading academic sion of solid tumours. In a randomised, controlled phase
institutions in order to advance the II efficacy trial in recurrent glioblastoma, treatment with
preclinical and clinical development asunercept in combination with radiotherapy has shown
and commercialisation of its statistically significant improvements in progression-free
proprietary drug candidates targeting survival and quality of life as well as a positive trend in
members of the TNF superfamily and overall survival compared to treatment with radiotherapy
the TNF receptor superfamily. alone. Glioblastoma patients expressing a certain bio-
marker associated with the CD95 ligand experienced
the greatest benefit from treatment with asunercept. The
median overall survival rate in biomarker-positive pa-
tients treated with asunercept more than doubled to 16
months compared to patients treated with radiotherapy
alone. Apogenix is developing a companion diagnostic
test based on this biomarker, so that asunercept can be
used as a personalised therapy. Asunercept was granted
PRIME (PRIority MEdicines) designation by the European
Medicines Agency for the treatment of glioblastoma,
which will greatly facilitate further clinical development
toward approval in the EU.
Apogenix

In MDS, the CD95 ligand inhibits the differentiation and


development of red blood cells. Asunercept blocks
the CD95 ligand, thereby enabling the maturation of
erythrocyte precursor cells to functional erythrocytes.
Final results of a phase I trial with asunercept in low
and intermediate-I-risk MDS patients demonstrated
an increase in erythrocyte precursor cells and a strong
trend toward reduction in transfusion frequency after
treatment with asunercept. In addition, an investigation
of parameters involved in erythropoiesis revealed how
asunercept stimulates the production of red blood cells
in these patients.
The CD95 system, which is inhibited by asunercept,
plays an important role in the progression of other solid
tumours and hematological diseases, underlining the
tremendous potential of this compound for the treatment
of malignant diseases beyond glioblastoma and MDS.

HERA-ligand technology platform


Apogenix’s highly qualified scientific team has devel-
oped the proprietary HERA-ligand technology platform
for the construction of novel fusion proteins that target
different TNFSF-dependent signaling pathways. Due
to their specific molecular structure, Apogenix’s fusion
proteins offer clear advantages over other biotherapeu-
tics such as antibodies and have the potential for broad
application in oncology.
Apogenix’s HERA-ligands have shown strong anti-
tumour efficacy in vitro and in vivo, with a benign safety
profile. The company has successfully out-licensed its
first programme based on this technology platform –
TRAIL receptor agonist APG880 and derivatives – to
AbbVie. AbbVie has initiated clinical trials with TRAIL re-
ceptor agonist ABBV-621 in patients suffering from solid
tumours, non-Hodgkins’s lymphoma, or acute myeloid
leukaemia. Apogenix is currently utilising its technology
platform to develop CD40, CD27, GITR, HVEM, and
4-1BB receptor agonists for cancer immunotherapy.

Management
Thomas Hoeger, PhD (CEO)
Peter Willinger (CFO)

10th European biotechnology guide 2020 22 | 23


Name · Scientific and Production Center About Armbiotechnology
“Armbiotechnology” NAS RA The Scientific and Production Center “Armbiotechnology”
Address/P.O. Box · 14 Gyurjyan Str. NAS RA is a state non-profit organisation established by
Postal Code/City · 0056 Yerevan the decision of the Government of the Republic of Armenia
Country · Republic of Armenia as a result of merging the “Scientific Research Institute of
Contact Person · Ashot S. Saghyan Biotechnology” CJSC and “Center of Microbiology and
Telephone · +374-10654182, +374-10654180 Microbial Depository” NAS RA.
Fax · +374-10654183
Email Address · armbiotech@gmail.com The following associations have been established and
info@armbiotech.am operate in this center: “Biotechnological Association of
Internet Website · www.armbiotech.am Armenia” and “Armenian Microbiological Association”.
Social Media · F I
Number of Employees · 146 The Scientific and Production Center “Armbiotechnol-
Founded (year) · 2010 ogy” is engaged in fundamental and applied research
Type of Laboratory · Biotechnological, microbiological, in biotechnology, microbiology, molecular biology, ge-
biochemical netics, gene engineering, and organic chemistry. The
Areas of Activity · Biotechnology, microbiology, molecu- main investigations carried out encompass such scien-
lar biology, genetics, gene engineering, tific areas as:
organic chemistry, biosynthesis,
biocatalysis, and biotransformation Microbiological synthesis
Biological Patents · l Microbiological method for obtaining Obtaining active microbial producers of biologically
water-soluble melanin // RA Patent active compounds (L- and D-amino acids, enzymes,
No3328 A, 2019 bioinhibitors of pathogens, biostimulators, bacterial
l Consortium of Enterococcus durans insecticides, biofertilisers) for the needs of medicine,
P13 MDC 9635 and Lactobacillus hel- the pharmaceutical and food industries, and agriculture
veticus KG5’ strains for the prepara- using gene-selective and gene-engineering methods.
tion of dairy products // RA Patent,
NoAM20190085, 2019 Biotransformation and biocatalysis
l Lactobacillus rhamnosus BTK 20-12 Development of biocatalytic methods for producing
bacterial strain producing arginine // amino acids, peptides, enzymatic preparations, polysac-
RA Patent No3273 A, 2019 charides, and other biologically active compounds.
External · l YSU Institute of Pharmacy (Armenia)
Collaborations l RUDN University (Russia)
l Belgorod State University (Russia)
l Paris-Sud University (France)
l University of Nantes (France)
l Hamburg University of Technology
(TUHH) (Germany)
l University of Rostock (Germany)
l The National Energy and Geology
Laboratory (LNEG) (Portugal)
l University of Liege (Belgium)
Member of l University of Zagreb (Croatia)
European l International Science and Technology
Biotechnology Center (ISTC), etc.
NET WORK
Armbiotechnology

Biomimetic asymmetric synthesis


Development of effective biomimetic catalysts and
methods for the synthesis of enantiomerically pure non-
protein amino acids, peptides, other preparations used
in the pharmaceutical industry, medical diagnostics, and
other fields of science and engineering.

Geobiotechnology
Development of biotechnological approaches to metal
bioleaching and the optimisation of metal extraction
processes.

Ecobiosafety
Processing of agricultural and food wastes, develop-
ment of effective technologies.

Biopreparations and bioadditives


Development of technologies for obtaining biologically
active compounds for food, medical, pharmaceutical,
and cosmetic products.

Microbial Depository Center


Maintenance of a national collection with its database
of non-infectious microbial cultures containing about
13,000 strains of bacteria, fungi, yeasts, and actinomyc-
etes. Study of microbial biodiversity, obtaining of new
prospective microbes of scientific and production sig-
nificance and their practical use. Isolation, classification
and study of biological and climatic diversity of Armenia
and the South Caucasian region.

Bioproducts
The Scientific and Production Center “Armbiotechnology”
NAS RA also stands out for its bio products, namely,
“NARINE” therapeutic-preventive and dietary product
based on Lactobacillus acidophilus MDC 9602; “ECO-
BIOFEED+” biofertiliser for agriculture; natural plant oils
used for food, medical-preventive, and cosmetic pur-
poses, and non-protein amino acids.

10th european biotechnology guide 2020 24 | 25


Name · AseBio – AseBio, the Spanish Bioindustry Asso-
Spanish Bioindustry Association ciation, organises the 10 th BIOSPAIN

Address/P.O. Box ·
Diego de León 49, 1ro. Izq. Pamplona (Navarre, Spain) will host the 10 th edition of
Postal Code/City ·
28006 Madrid BIOSPAIN. The event is organised by AseBio, the Span-
Country ·
Spain ish Bioindustry Association, with the collaboration of
Contact Person ·
Esther Campos Sodena – Government of Navarre for the 2020 edition.
(Business Development &
International Affairs Coordinator) With more than 1800 delegates from 31 countries, +200
Telephone · +34-912109310-74 exhibitors, and over 3,330 one-to-one meetings, Bio-
Email Address · ecampos@asebio.com spain is the third largest biotech event in Europe, fol-
Internet Website · www.asebio.com lowing directly in the footsteps of BIO-Europe and
Social Media · FL I I  BIO-Europe Spring.
Number of Employees · 13
Founded (year) · 1999
20 years facilitating the development of
Areas of Activity · At AseBio, the Spanish Bioindustry the biotech industry through BIOSPAIN
Association, we bring together and BIOSPAIN is the tool AseBio uses to create business
represent the interests of companies, and investment opportunities, and thanks to the +17,000
associations, foundations, universities, one-to-one meetings held in the past 10 years, we can
and technology and research centres no doubt say that AseBio has been an integral part of
that work in the field of biotechnology the development of the Spanish biotech ecosystem.
in Spain.
Today, Spain ranks 4th in Europe by the number of com-
panies (+600), 5th in employment, and 8th by the amount
of venture capital investment. The biotech sector’s
contribution to Spain’s economy rose to 6.05 billion
euros (0.7% of the Spanish GDP) and is responsible for
more than 92,000 direct, indirect, and induced jobs,
which is 0.5% of all employment (25,000 of these jobs
were created directly by biotech companies).

An untapped source of biotech innovation


Spain produces around 3% of all scientific publications
in the world and ranks 10th in scientific production (also
in fields related to biotechnology), but for a long time
this didn’t translate into relevant deals.

Today, more than €400m of venture capital, counting


recent fundraising and anticipated closings, is forecasted
to be available to fund the creation and growth of start-ups
in the life sciences sector. There is a great potential in
therapeutics as well as in vaccines and medical devices
asebio

emerging from Spain’s top research centres, many of them


outstanding in their field in Europe.

BIOSPAIN is also the right place to learn more about the


science coming out of research institutions, to identify
licensing deals, or to network with the main venture
capital firms and pharmaceutical companies from Spain
and the rest of Europe.

All of the above is complemented by a complete confer-


ence programme where the main and most current
topics will be covered, such as Immunotherapy, CAR-T,
Precision Medicine, CNS, Circular Economy, Agrobio-
technology, and Artificial Intelligence.

About AseBio
AseBio brings together and represents the interests of
companies, associations, foundations, universities, and
technology and research centres that work in the field
of biotechnology in Spain.

Since 1999, we have worked to achieve positive political


and economic changes that promote and boost the
development of the Spanish biotechnology industry. In
order to do this, AseBio works closely with regional,
national, and European legislative bodies, as well as with
all those social organisations that are committed to us-
ing biotechnology to improve citizens’ quality of life,
environmental sustainability, economic development,
and skilled job creation.

For AseBio, cooperation and working as part of a net-


work is a priority. This is why we are members of Eu-
ropaBio, the European Bioindustry Association, which
is made up of almost one hundred business organisa-
tions, together representing the interests of over 1,800
European companies.

10th european biotechnology guide 2020 26 | 27


Name · Axolabs GmbH Expertise and scientific excellence
Axolabs is the leading CRO focused on the discovery
Address/P.O. Box ·Fritz-Hornschuch-Str. 9 and preclinical drug development of oligonucleotide
Postal Code/City ·95326 Kulmbach therapeutics and other nucleic acid medicines. Based
Country ·Germany on our world-leading know-how and 20 years of experi-
Contact Person ·Dr Roland Kreutzer ence we provide high-end preclinical solutions tailored
Telephone ·+49-9221-82762-0 to our clients’ specific needs.
Fax ·+49-9221-82762-99
Email ·info@axolabs.com Services and products
Website ·www.axolabs.com Manufacturing
Number of Employees ·106 ·· High-quality oligonucleotide synthesis
Founded (year) ·2000 (under the name of Ribopharma; ·· Custom-tailored process optimisation
acquired by LGC in 2017) ·· Long RNA/DNA
Type of Laboratory · S1, S2 ·· Wide range of chemically modified oligonucleotides
and conjugates
Areas of Activity · Preclinical research solutions with a ·· Potency and stability improvement
focus on oligonucleotide therapeutics ·· Impurity markers and reference standards
and other nucleic acid medicines, ·· Lipid synthesis
including high-quality oligonucleotide
manufacturing, analytics, bioanalytics, Oligonucleotide and nucleic acid analytics
lead molecule identification, in vitro ·· Physicochemical and thermodynamic characterisation
and in vivo pharmacology, GMP release ·· Stability determination in biological matrices
·· Identification of metabolites by LC/MS
Biological Patents · Proprietary bioanalytics assay for the ·· Analysis of nucleic acid-protein interactions
detection and quantification of
oligonucleotides in blood and tissue; Bioanalytical services
proprietary lipid platform for the ·· Unique and proprietary assay system for the sensitive
cellular delivery of nucleic acids detection of oligonucleotides and mRNA from bio-
logical matrices
External · Axolabs collaborates with the majority ·· GLP-certified test site (GCP-qualified)
Collaborations of research groups in the field of ·· Small and large molecules (at LGC)
oligonucleotide therapeutics ·· Biomarkers (at LGC)
worldwide, including >15 Big Pharma
enterprises, >200 biotech companies, Oligonucleotide lead identification
and >30 academic research institutes ·· Bioinformatics assessment for sequence pre-selection
·· Drug design and synthesis
Request for · Axolabs is looking for partners to ·· High-throughput in vitro screening
Further Collaborations combine our expertise in preclinical ·· Lead characterisation and optimisation
development of oligonucleotide ·· In vivo efficacy and early safety assessment
therapeutics with promising
therapeutic approaches Biological and pharmacological tests and analyses
·· Safety and toxicology analyses
·· Cell-based assays for cell function, proliferation, and
toxicity
axolabs

·· Ligand-receptor interaction and uptake studies/histology


·· Flow cytometry
·· Protein analysis (at LGC)
·· Analysis of mRNA

Platform for functional cell type-specific delivery of


oligonucleotides and mRNAs
·· In vitro functional analysis and in vivo models
·· Rational oligonucleotide design tailored for specific
delivery systems
·· Proprietary lipid nanoparticle formulations

CMC analytical services


·· GMP-compliant
·· Broad analytical capabilities
·· Materials science

GMP-compliant oligonucleotide and mRNA release and


stability analysis
·· Analysis of oligonucleotides and mRNA drug sub-
stance and drug product
·· Analytical methods/equipment:
·· Oligonucleotide and mRNA purity and identity by
UPLC with ESI-MS detection (Thermo TripleQuad
and OrbiTrap for High-Resolution-MS)
·· Temperature-controlled UV spectroscopy
·· Lipid characterisation by UHPLC with UV and CAD
detection
·· LNP characterisation by Malvern particle sizer
·· Nucleic acid encapsulation by fluorescence spec-
trometer
·· Water determination by Karl-Fischer, pH, osmolarity
·· ICH-compliant stability studies

mRNA Therapeutics
·· Identity confirmation by mRNA fingerprinting
·· Capping efficacy by HPLC/MS
·· Characterisation of mRNA drug product
·· mRNA and mRNA-LNP bioanalysis

Gene-editing therapeutics
·· Unprecedented purity of therapeutic sgRNAs
·· Superior biological editing efficiency
·· Advanced analytics

10th european biotechnology guide 2020 28 | 29


Name · Biaffin GmbH & Co KG Company overview
Biaffin GmbH & Co KG is an ISO 9001:2015 certified
Address/P.O. Box · AVZ 2, Heinrich-Plett-Str. 40 bioanalytical service provider specialised in the applica-
Postal Code/City · 34132 Kassel tion of biosensors based on surface plasmon resonance
Country · Germany (SPR) for biomolecular interaction analysis (BIA). BIA
Contact Person · Dr Bastian Zimmermann technology is ideally suited for kinetic characterisation
Telephone · +49-561-8044668 of any interacting molecules in real-time in a label-free
Fax · +49-561-8044665 state. Biaffin has extensive knowledge and many years
Email · info@biaffin.com of experience in various application areas and supports
Websites · www.biaffin.com as a competent partner the drug development programs
www.proteinkinase.biz of pharma, biotech and generic drug companies, as well
Social Media · FIQ as scientific institutions worldwide. The service is per-
Number of Employees · 8 formed by a highly specialised team (PhD level scientists)
Founded (year) · 2001 either under Non-GMP or GMP conditions in laboratories
Type of Laboratory · Analytical, ISO 9001:2015, GMP well equipped with several state-of-the-art SPR instru-
Areas of Activity · Service provider for biomolecular ments (Biacore). The company’s expertise is docu-
interaction analysis using SPR Biacore mented by a number of peer-reviewed publications in
technology; supplier of recombinant renowned scientific journals. Sufficient capacities in SPR
proteins and reagents for kinase instruments enable Biaffin to start interaction studies at
research and signal transduction short notice, to rapidly perform a number of projects in
parallel and to obtain results on time.
External · Collaborations with academic research
Collaborations groups and industrial partners
Analytical services
Request for · Biaffin is looking for strategic partners Biaffin’s SPR services in pre-clinical drug development
Further Collaborations interested in complementing their comprise customised assay development, hit validation,
analytical portfolio with SPR Biacore secondary screening, kinetic profiling and lead optimisa-
technology. tion of small-molecule drugs. Early ADME studies (serum
protein binding) and detailed studies on the mode of
action, including thermodynamic binding analysis, fur-
ther support the drug development process.

In the field of therapeutic antibody and biosimilar devel-


opment, Biaffin offers SPR services for qualitative ki-
netic ranking, comprehensive kinetic characterisation,
determination of active concentrations based on bind-
ing activity (using calibration curves or calibration-free
methods), batch to batch comparison, assay qualifica-
tion/validation and stability analyses for diagnostic and
therapeutic purposes. Pair-wise epitope mapping, tests
for specificity, cross-reactivity, immune-reactivity,
variances in binding kinetics based on species differ-
ences and interaction analysis with Fc gamma receptors
(CD16, CD32, CD64) and neonatal Fc receptor (FcRn)
Biaffin

complement Biaffin’s antibody services.


In addition, Biaffin offers customised SPR assay devel-
opment and contract research elucidating specificity,
selectivity, cofactor requirements, mechanism of action
and thermodynamics of given interactions of proteins,
peptides, nucleic acids, small molecules, carbohydrates
and membranes. Biochemical and enzymatic assays
broaden the range of services to meet the complex is-
sues of clients regarding inhibitor recognition by target
enzyme, effects of small-molecule inhibitors on enzyme
activity, substrate specificity and mode of action.

Catalogue products
Apart from analytical services, Biaffin offers a broad
range of products serving customers’ needs in kinase
research and exploring cellular signal transduction
pathways. Biaffin’s high-quality product portfolio, avail-
able from the online shop www.Proteinkinase.biz, com-
prise recombinant proteins (kinases, phosphatases,
cytokines, receptors, CD antigens), peptide substrates,
specific inhibitors and antibodies, as well as biochemi-
cal assays (ATP determination kit) for customers’ in-
house research.

Quality statement
Biaffin has successfully implemented and maintains a
Quality Management System according to ISO 9001:2015
/GMP standard that enhances the ability to continually
supply high-quality products and provide innovative
services according to the highest quality standards,
which consistently meet the needs and expectations of
our clients.

10th european biotechnolgoy guide 2020 30 | 31


Name · BIO.NRW The Home of Biotech BIO.NRW – Business for biotech
BIO.NRW is the biotechnology network of North Rhine-
Address/P.O. Box · Merowingerplatz 1 Westphalia (NRW). We catalyse the sustainable develop-
Postal Code/City · 40225 Dusseldorf ment of the state’s biotech sector by building on NRW’s
Country · Germany strengths in industrial and pharmaceutical biotechnology,
Contact Person · Dr Nils Schrader bioeconomy, and in enabling technologies. BIO.NRW is
Telephone · +49-211-385-469-9200 part of a state government initiative, named ‘Excellence
Fax · +49-211-385-469-9220 NRW’, to position NRW as Germany’s number one state
Email · bio.nrw@bio.nrw.de for innovation.
Website · www.bio.nrw.de
Social Media · L Our services include:
Number of Employees · 6 Technology Transfer
Founded (year) · 2008 Tech transfer support is a key contribution from BIO.NRW.
We organise events, working platforms and meetings to
Areas of Activity · | Technology transfer promote the dialogue between business, research, inves-
| Support of biotech companies, tors and policy-makers and to activate cooperation.
esp. SME
| Support of biotech start-ups, Biotech business & sciences
coaching & financing BIO.NRW compiles comprehensive and current online
| National and international fairs, databases of academic institutions and companies active
exhibitions, and conferences in the life sciences in NRW. Free to access and easy-to-
| Analysis of biotechnology in North use, these resources are valuable tools for identifying
Rhine-Westphalia for location data business partners. More information on www.bio.nrw.de
| Marketing & PR for the biotech state
of North Rhine-Westphalia Fairs, exhibitions and conferences
| Promotion of young academics Companies and academic institutions can generate
| Online jobfair awareness of their activities locally, nationally and inter-
nationally by being a part of the BIO.NRW common
External · | EIT Health e. V; local to international stands at fairs, exhibitions and conferences. BIO.NRW
Collaborations companies, research institutions, also organises a series of workshops and symposia,
financiers and further biotech called BIO.NRW.academy.
stakeholders
| ChInValue – China-NRW-cooperation Support of young professionals
(BMBF) BIO.NRW takes a special interest in supporting young
professionals in biotechnology. We participate in conven-
tions and exhibitions to bring graduates in contact with
representatives from industry and academic science. The
‘Business Angel Network – BIO.NRW’ helps financing and
funding biotech start-ups. In addition, the idea of an an-
nual “BIO.NRW Business Angel Congress” is, to assist and
to supply the highly divers investors’ community of business
angels, venture capitalists, institutional investors and their
potential clients, such as founders and SMEs with the most
recent and updated finance and investment information.
NRW – Germanys most
international business BIO.NRW

location

Home to 20,000 A snapshot of NRW’s biotech sector


North Rhine-Westphalia is situated at Europe’s geograph-
foreign companies ic and economic centre. NRW is the state with Germany’s
highest gross domestic product (GDP), corresponding to
4.4% of the European GDP (EU-28). If classified as an in-
dependent nation, NRW would rank 18th in the world, just
between Netherlands and Saudi Arabia.

A multitude of successful start-up and spin-off compa-


North Rhine-Westphalia nies have been launched in NRW, alongside a strong
chemical and pharmaceutical presence. In total, the state
is home to more than 519 life science companies, among
them 119 core biotechnology firms that together account
for 40.1% of the German biotech turnover. It is also
Europe’s number one in patenting biotech inventions
(according to BIOCOM AG statistics). With 56 universities
and research institutions that conduct life science re-
search, NRW also enjoys the highest concentration of
academic institutions within Europe. These include six
Max-Planck-Society life science research institutes.
There are three Helmholtz research centres, five Fraun-
hofer Institutes and six Leibniz Association facilities.
USA 1,700*
One notable strength of NRW’s biotech industry is indus-
trial (‘white’) biotechnology, which benefits from the states
China 1,100* strong chemical industry, e.g. Evonik and Henkel. The
sector is connected by the Cluster of Industrial Biotech-
nology, named CLIB2021.
Japan 600*
Beyond ‘white biotech’, the pharmaceutical ‘red’ biotech
France 1,100* sector is also strong e.g. especially in personalised medi-
cine. In 2018, some 44.1% of the biotech companies in
NRW were actively developing new drugs and diagnostics.
Great Britain 1,500* Some, like the Bayer AG, Grünenthal and UCB are global
players in the pharmaceutical sector. Same goes for diag-
nostics with e.g. Qiagen and Miltenyi Biotec. In Q3 2019,
Switzerland 1,500* the drug pipeline of all companies combined contained 88
products and candidates. 12 of these were in clinical
phases I–III, 8 drugs are on the market. To support and
Netherlands 4,100*
develop pharmaceutical biotechnology, BIO.NRW found-
ed in 2010 the strategic initiative BIO.NRW.red. The aim is
to build a sustainable network that connects the major
*Number of foreign companies in NRW (selection)
contributors to medicine, healthcare, the pharmaceutical
industry and red biotechnology in the state.

10th european biotechnology guide 2020 32 | 33


Name · BIOCOM AG The information specialist
Biotechnology, life sciences, knowledge-based bio-
Address/P.O. Box · Luetzowstr. 33–36 economy, medical technology: experienced industry
Postal Code/City · 10785 Berlin and scientific specialists at BIOCOM have been tracking
Country · Germany the development of life sciences from research to mar-
Contact Person · Dr Boris Mannhardt ket for more than 30 years – content-driven and results-
Telephone · +49-30-264921-0 oriented, enthusiastic about the subject and always
Fax · +49-30-264921-11 committed to the customer.
Email · service@biocom.de
Website · www.biocom.de To be close to its clients across Europe and optimally
Number of Employees · 35 suppor t the media, event and ser vice activities,
Founded (year) · 1986 BIOCOM runs its headquarters in Berlin and has further
offices in Brussels, Vienna and in Switzerland.
Areas of Activity · | C onsulting
|P  ublishing Consulting and studies
| E vents As a leading information specialist in ­Europe, BIOCOM
has extensive knowledge and experience in all life sci-
ence areas, be it medtech, pharmaceutical development
or the bioeconomy including agricultural innovation and
industrial biotechnology. Building on this, the project
management division offers a comprehensive range of
services for companies and the public sector – wher-
ever state-of-the-art biotechnology calls for specialised
information and communication processes.

BIOCOM prepares market, financial and technology-


specific studies with the highest user value for its clients.
It conducts qualitative and quantitative analyses, devel-
oped closely with customers and delivering focused,
accurate data. The result is clear, informative dossiers
with highest quality information to effectively support
professionals in industry and politics.

Industry surveys
Consistent and internationally comparable statistics are
a valuable tool for political decision makers to effec-
tively support the life sciences. BIOCOM has long-
standing experience in sector-specific surveys of both
industry and academia. Based on global definitions such
as the OECD’s biotechnology statistics framework,
BIOCOM has so far performed surveys in several Euro-
pean countries. Survey results are kept in proprietary
databases of the European life science sector and are
aggregated and processed for publication.
BIOCOM

Publishing
The unique feature of printed or electronic media pub-
lished by BIOCOM is their relevance in practical work.
From magazines like European Biotechnology, up-to-date
books, directories, internet platforms to videos, they are
fact-based and strongly content-related – simply a must
on many desks or screens.

Events
Proprietary conferences, conventions and congresses
have long been part of the company’s successful ac-
tivities. BIOCOM events are a perfect example of content
relevance and superb organisation. BIOCOM’s event
management team also organises large and small events
on behalf of customers: from focused workshops to
large professional congresses and exhibitions with
thousands of attendees and visitors.

Communication + dissemination
In all research projects funded under the European
Commission’s framework programme Horizon 2020,
the work package of communication and dissemination
is a key element. Progress of the project and relevant
research results need to be published through various
channels to make the project – and European funding
activities as such – more visible. Under the COMDIS
label, BIOCOM offers these services to research con-
sortia across Europe.

To inform all stakeholders in a consortium as well as the


interested public including policy makers about the
objectives and results of the project, a coherent and
clear communication strategy is essential. This is par-
ticularly true for large collaborative projects that involve
many partners including universities and SMEs across
Europe in a complex scientific approach over a long
period of time. BIOCOM’s tasks in these projects com-
prise in particular:
© photothek/Thomas Trutschel

·· Branding of the project and preparation of communi-


cation material
·· Creation and maintenance of the project website
·· Videos
·· Media work
·· Organisation of conferences and workshops

10th european biotechnology guide 2020 34 | 35


Name · Bioengineering AG Company profile
The visionary idea to provide the biotechnological
Address/P.O. Box · Sagenrainstrasse 7 industry and research community with equipment for
Postal Code/City · 8636 Wald excellence led to the foundation of Bioengineering in
Country · Switzerland 1972. This idea has been put into practice by designing
Contact Person · Carlo Buck and constructing fermentation systems, including all
Phone · +41-55-256-81-11 components for large and small scales. By expansion
Fax · +41-55-256-82-56 of our product portfolio, based on the latest advance-
Email · info@bioengineering.ch ments in biotechnology, we are carrying this founding
Website · www.bioengineering.ch concepts into the 21st century.
Number of Employees · 140
Founded (year) · 1972 Our company has been independent and autonomous
since it was established. This approach has little in com-
Areas of Activity · l Engineering & design mon with current corporate mind sets and the vast array
l Service of management models, which allegedly have answers
l Plants for everything. It gives us the liberty for result-orientated
l Bioprocess control commitment to the process specifications. Our research
l Lab & pilot and design teams know how to set customers’ ideas on
l Components the road to implementation and turn them into practical
reality, based on optimised organisational structures
and – not least – sound financial planning.

Product portfolio
Engineering & Design
We build plants for our customers that meet their specif-
ic requirements. We do this at Bioengineering by having
a team of dedicated engineers and designers working
on every stage of a project. From the idea to the finished
plant, there is a strong culture of innovation. Our many
years of experience in project management enable us
to implement fast-track projects efficiently.

Service
The support we offer goes beyond the planning, construc-
tion, and commissioning of plants. We provide expert
knowledge, servicing, inspection, and documentation to
assist with the operation of your plants. We perform two
roles in one: that of an expert and a reliable partner.

Plants
We design and build complete bioreactor and fermenter
systems for well-known pharmaceutical and food
companies. These systems are used in laboratories
bioengineering

and production facilities to manufacture vaccines,


biosimilars, starter cultures, and other products. It is
no accident that our plants serve as a reference for an
entire industry. With more than 45 years of experience in
building plants, we have the experience, the knowledge,
and the innovative capacity to realise even the most
complex of plants.

Bioprocess Control
We develop complex automation solutions with software
and hardware for the plants and are thus in a position
to offer a wide range of architectures and designs. This
helps our customers to manage and monitor their plants
perfectly and reliably.

Lab & Pilot


We develop and build fermenters and bioreactors for
laboratories and production facilities across the world.
These range from small expandable modular bench-top
devices for research and development departments to
scalable big plants for the manufacturing industry.

Components
We develop and build components for our customers’
plants which perform very specific tasks depending on
the application and the requirements. For example, com-
ponents which ensure that cleaning is carried out in com-
pliance with strict hygiene regulations and which have
been reliably carried out in our plants for many years.

Every customer enjoys the advantages of our modular


design approach: cost-effective transport, rapid instal-
lation, and streamlined testing and quality control. Our
quality-assurance manual is the control system that
ensures unified monitoring and documentation of the
entire production sequence, with precise specifications,
instructions, and prescribed procedures.

But the commitment to our customer does not end,


once the system is installed and qualified. For us quality
assurance also means providing our customers with af-
tersales services and replacement parts for many years
to come. We have honoured that commitment for every
facility built by Bioengineering since 1972.

10th european biotechnology guide 2020 36 | 37


Name · BIOFABRI Company overview
Biofabri is an European-based organisation created with
Address/P.O. Box · La Relva s/n Torneiros a vision: to research, develop, and manufacture human
Postal Code/City · 36410 Porriño vaccines and biologicals.
Country · Spain
Contact Person · Beatriz Díaz With over 75 years of experience and a highly qualified
Telephone · +34-986-330400 team of professionals to back up its expertise, Biofabri
Internet Website · https://biofabri.es/en/ is focused on human health, with strong technical, de-
Social Media · I velopment, and manufacturing capabilities.
Number of Employees · +250 (Zendal Group)
Founded (year) · 2008
Vacines and immunotherapy products
Areas of Activity · l Biotechnology Biofabri also is supported by an R&D department that
l CDMO is staffed with a team of professionals that have exten-
l Development sive scientific experience and collaborate with interna-
l Manufacturing tional research institutes and universities to develop new
l Vaccines and ambitious projects, including among others:
l Tuberculosis vaccine ·· MTBVAC PRIME_ Tuberculosis vaccines for new-
l Aseptic filling borns, 2A clinical trial.
l Lyophilisation ·· MTBVAC BOOSTER_Tuberculosis vaccines for ado-
l GMP upstream & downstream lescents and adults, 2A clinical trial.
processes
l Virus, bacteria, and cell cultivation
BIOFABRI a biopharmaceutical CDMO
Relevant R&D Budget · 11% revenue EU GMP certification (EMA)
Biofabri is an ideal partner for any organisation intending
to advance its biologic product candidates from develop-
ment scale to clinical Phases I to III, and commercial
supply capability that is expected to be ready in 2021.

Your partner for biologics manufacturing


·· Live & inactivated bacteria & viral vaccines
·· Roller bottles & cell factory
·· Single-use bioreactors
·· Sterile processing systems
·· Centrifugation, ultrafiltration, diafiltration
·· Chromatography
·· Aseptic filling into vials
·· Lyophilisation
·· Process development/optimisation
·· Storage
·· Cold chain up to –80 ºC
biofabri

Services
·· cGMP preparation and control of master and working
seed lots of cells, virus, and bacteria.
·· GMP upstream & downstream processes, based on
single-use equipment.
·· Upstream process optimisation for virus, bacteria,
and cell cultivation.
·· Downstream process optimisation, with capabilities for
centrifugation, purification, and immunopurification.
·· Chromatography
·· Vaccine formulation.
·· Wide capacity for aseptic filling.
·· Lyophilisation: Up to 24,000 vials for IMP. A 40m 2
freeze dryer with approximately 200,000 to 250,000
vials capacity for commercial scale is also planned.
·· Stability testing of seed lots, intermediates, and fin-
ished products. In-use stability studies.
·· Labelling & packaging
·· Wide capacity for physical-chemical and biological
control, including sterility test.
·· Implementation of methods of control of intermediate
and finished products.
·· Preparation of investigational medicinal product ap-
plication quality dossier for clinical trial IMP authorisa-
tion.
·· Biological and sterile products release.
·· Storage and distribution.

BIOFABRI belongs to ZENDAL, a business group consist-


ing of 7 companies focused on biotechnology and en-
gaged in the development, manufacturing, and marketing
of biological products for human and animal health.
Zendal group consists of CZ Vaccines, Biofabri, Vetia,
Petia, Zinereo Pharma, Probisearch, and Bialactis.

10th european biotechnology guide 2020 38 | 39


Name · Biological Industries Biological Industries (BI) –
a global CMO for specialty media
Address/P.O. Box · Kibbutz Beit Haemek Biological Industries develops,manufactures,packs and
Postal Code/City · 25115 supplies cell culture products for academic research,
Country · Israel diagnostic labs, and hospitals, as well as for biotechnol-
Contact Person · Dr Sabine Hahnau-Jurth ogy, biopharmaceutical and pharmaceutical industries.
(Head of Sales & Marketing Europe) With almost 40 years of experience, BI specialises in
Telephone · +49-151-58406549 serum-free, xeno-free, animal component-free, and
Fax · +49-3375-5856575 chemically fully defined media as well as contract
Email Address · info@bioind.com manufacturing services that range from raw material
Internet Website · www.bioind.com supply through labelling and packaging to ready-to-
Social Media · FL I  market product.
Number of Employees · 130 Whether for basic research, drug discovery, or for
Founded (year) · 1981 therapeutic applications, stem cell differentiation re-
quires standardised culture methods to ensure repro-
Areas of Activity · Development and production of ducible and reliable results. To support stem cell re-
chemically defined, xeno-free, search and production, Biological Industries (BI) offers
animal-free, or serum-free specialty a specific set of xeno-free, animal-free cell culture me-
media for cell culture and cytogenetics dia, stem cell reagents, and protocols. This evolving
product portfolio offers a powerful base to support re-
searchers in culturing, reprogramming, characterising,
and differentiating stem cell colonies. From identifying
colonies and their lineages to monitoring changing
morphology, BI’s stem cell products are accelerating
researchers’ efforts to understand disease processes.

BI is edicated to site alignment and production proc-


esses that allow clients to confidently use BI as their
sole supplier of medical cell media products. The com-
pany’s extensive experience in liquid manufacturing and
packaging makes partnering with BI a confident choice
as products progress from the laboratory and pilot stage
to full-scale production. BI scientists, along with their
latest technologies, are available to help offer direction
with challenges involving cell lines, media, and process
development challenges. The BI team will identify the
best available medium and is able to scale up to a com-
mercial level within a short period of time. BI can be a
reliable outsourcing partner to expand its clients’ capa-
bilities. Though almost any of the current catalogue’s
cell culture media formulations can be adjusted to cre-
ate a customised cell culture medium, BI’s media de-
velopment and optimisation services are clearly focused
on stem cell product development. BI’s tailored serv-
biological industries

ices include: sterile filtration and aseptic filling, flexible


packaging in industrial single-use (bulk) bags from 0.5
to 2,000 litres, pilot scale freeze drying (lyophilisation),
and an extensive range of quality control services.

The highest quality standards


As a manufacturer for the life sciences industry, Bio-
logical Industries is fully committed to current Good
Manufacturing Practices (cGMP) comprising local laws
as well as international guidelines adopted by both the
US Food and Drug Administration (FDA) and the Euro-
pean Medicines Agency (EMA). BI’s quality systems
comply with the international standards for Quality
Management Systems as defined by ISO 13485:2016
and are routinely audited by accredited external bodies.
Their manufacturing facility is an ISO 9001:2015 and ISO
13485:2016 certified facility and their controlled environ-
ment clean rooms are graded from ISO 8 up to ISO 5
(classified from class 100,000 to 100). Products are di-
vided into two groups: “For Research Use Only” and
“For In Vitro Diagnostics”.

10th european biotechnology guide 2020 40 | 41


Name · BioNukleo GmbH Nucleoside analogues have been in clinical use for over
50 years in the treatment of severe diseases such as can-
Address/P.O. Box · Ackerstraße 76, ACK24 cer, viral infections, and immunopathologies. Addition-
Postal Code/City · 13355 Berlin ally, the introduction of modifications into nucleic acids
Country · Germany confers altered stability and/or target recognition, which
Contact Person · Dr Anke Wagner can be utilised in a multitude of biochemical assays.
Telephone · +49-30-314-72183
Fax · +49-30-314-27577
Email Address · info@bionukleo.com Company overview
Internet Website · www.bionukleo.com Founded in 2014 as a spin-off of the Chair of Biopro-
Number of Employees · 7 cess Engineering at the Technische Universität Berlin,
Founded (year) · 2014 BioNukleo can look back on over 15 years of research
experience in the field of chemo-enzymatic synthesis of
Areas of Activity · l Biocatalysis nucleic acid derivatives and the efficient expression of
l Nucleoside and nucleotide analogues hard-to-express enzymes. Our office and laboratories
l Process development are located at the TU’s campus in Berlin-Wedding, Ger-
many. BioNukleo’s key activities are the production of
External · Close cooperation with academic nucleoside and nucleotide analogues, the synthesis of
Collaborations institutions and industrial partners enzymes, and customised bioprocess development.

Nucleosides, sugars, and enzymes


Chemical synthesis of modified nucleosides, nucle-
otides, and sugar phosphates remains challenging and
often requires multiple synthesis steps. This results in
low yields, high amounts of waste, and high costs.
BioNukleo’s approach to producing nucleoside ana-
logues is based on the use of biocatalysts in batch or
continuous-flow reactions. Our enzyme library includes
both highly specific and promiscuous enzymes focusing
on enzymes that can modify nucleosides, nucleotides,
or monosaccharides.

Process development
By including enzymatic steps in the process, BioNukleo
provides an optimal synthesis solution for nucleic acid
derivatives that cuts costs, reduces the amount of time
and factory space needed, and improves the ecological
footprint. We cover all steps of process development –
from initial small batch testing via process optimisation
to upscaling strategies for industrial production – and
deliver professional process descriptions tailored to our
client’s specific needs.
bionukleo

Catalogue products
Small molecules
Highly efficient enzymatic or chemo-enzymatic syn-
thesis routes for nucleic acid derivatives have been
developed. High product yields and purity are obtained
in these processes.
·· Sugar phosphates
Ribose-1-phosphate Ba salt, deoxyribose-1-phos-
phate Ba salt, and arabinose-1-phosphate Ba salt
·· Nucleosides
Cladribine, clofarabine, ribavirin, and cytarabine
·· Nucleotides
Natural mono-, di-, and trinucleotides as well as nu-
cleotides with wide modifications in base or sugar,
e.g. fludarabine-phosphate

Enzymes
Various enzyme libraries are available to produce a wide
range of nucleic acid derivatives. Enzymes from different
organisms are heterologously expressed in Escherichia
coli and purified by affinity chromatography.
·· Nucleoside phosphorylases
Catalyse the reversible phosphorolytic cleavage of nu-
cleosides into pentose-1-phosphate and nucleobase
·· Nucleoside kinases
Add phosphate groups to the 5’-end of nucleosides or
nucleotides to create nucleotides (NMP, NDP, or NTP)
·· Nucleoside hydrolases
Break the N-glycosidic bond between sugar and base
·· Ribokinases
Transfer a phosphate group from ATP to pentoses to
create pentose-5-phosphates
·· Phosphopentomutases
Convert pentose-5-phosphate to pentose-1-phosphate
and vice versa

10th european biotechnology guide 2020 42 | 43


Name · BIOTECON Diagnostics GmbH The Food Safety Experts
As a leader in molecular biological testing methods for
Address/P.O. Box · Hermannswerder 17 food, beverages, and feedstuff, BIOTECON Diagnostics
Postal Code/City · 14473 Potsdam constantly strives to make the planet a better and safer
Country · Germany place. We imagine a world where no one gets sick from
Contact Persons · Dr Kornelia Berghof-Jäger (CEO) the food and drink they consume.
Alois Schneiderbauer (CBO) Situated in Potsdam, Germany, our story began more
Telephone · +49-331-2300-200 than 20 years ago, seeking to put an end to foodborne
Fax · +49-331-2300-299 diseases, which are increasingly becoming a threat to
Email · bcd@bc-diagnostics.com human health. Today, we have grown to become one
Website · www.bc-diagnostics.com of the pioneers in designing products for food safety
Social Media · F I Q excellence. Our team of highly qualified experts from
a variety of academic backgrounds excel in providing
first-in-class, innovative rapid solutions for DNA/RNA
extraction and detection of a wide range of test param-
eters based on real-time PCR and ELISA.

foodproof ® – products you can trust


Our comprehensive foodproof ® product line ensures
fast and accurate detection of foodborne pathogens
and viruses, spoilage organisms such as beer spoilers
or Alicyclobacillus, GMOs, and allergens, as well as
animal species testing in all kinds of food, feed, and
beverage matrices.
Our clients include some of the largest food and bever-
age companies in the world, as well as private custom
service laboratories, government bodies, and research
facilities.
We are passionate about developing innovative solutions
that achieve optimal sensitivity and specificity. Many of
our foodproof® kits for the detection of pathogens have
been validated and approved by independent institutions
such as AOAC, NordVal, and MicroVal. Customers can
rest assured our “Made in Germany” products are reliable,
precise, and guarantee the highest standards.

Automation – making lab life easier


The foodproof® RoboPrep+ series, including the unique
new RoboPrep Fusion®, represents a set of commercially
available, fully automated DNA-extraction and PCR setup
systems validated and certified for the food and beverage
industry. The RoboPrep+ Series saves hands-on time
and reduces human error, while significantly increasing
laboratory efficiency. The systems are accurately able to
ADVANCED Biotecon
MOLECULAR TESTING

FOOD detect all food-related organisms in various food matrices


and environmental samples. Several foodproof® Mag-
netic Preparation Kits enable the automated extraction
Real-time PCR Kits of DNA from food and feed samples for the detection of
pathogens, GMOs, animal species, and allergens.

microproof® – fast & safe Legionella testing


Contaminated water is a major concern for public health,
resulting in high demand for diagnostic tools to monitor
BEVERAGES water systems. Our real-time PCR-based microproof ®
LyoKits detect and quantify pathogens such as Legionella
in environmental samples and water. They offer reliable
analyses with the highest degree of accuracy and con-
sistency in a short space of time.

DNA / RNA Extraction Kits Because quality is everything


Dedicated to providing the highest quality products
and services, we market our products directly as well
as through an expanding network of local distributors
and worldwide sales channel partners. Trust and trans-
parency are paramount to our longstanding customer
relations. Our DIN EN ISO 9001 certification since 2003,
VETERINARY as well as DIN EN ISO 17025 accreditation in the service
sector since 2005, are testament to our high-quality
manufacturing standards.
The company’s ISO 17025 accredited custom service
laboratory provides superior experience in microbio-
Instruments logical and molecular biological service testing of food
and beverages, water, and disinfectants, as well as
pharmaceutical and cosmetics products.

Keeping at the forefront of food safety


We pride ourselves on staying abreast of customer needs
and challenges by offering the very best in real-time PCR
ENVIRONMENTAL SAMPLES and automation as well as other flexible solutions such as
MALDI-TOF MS. The customisable MALDI Biotyper refer-
ence libraries (e.g. D-MASS) enable rapid microorganism
identification, microarrays, and sequencing.
Our broad portfolio of food, beverage and feedstuff
testing methods complemented by our state-of-the-art
instruments offer ideal solutions for production and
processing companies, seeking innovative, tailored, and
www.bc-diagnostics.com economical approaches.

10th european biotechnology Guide 2020 44 | 45


Name · Black Swan Analysis Ltd Making Business Decisions Clear
Black Swan Analysis is a versatile pharmaceutical con-
Address/P.O. Box · The Place, Bridge Ave sultancy that specialises in delivering robust valuations
Postal Code/City · SL6 1AF Maidenhead and commercialisation plans for the healthcare industry.
Country · United Kingdom With the flexibility to approach complex issues, and the
Contact Person · Nic Talbot-Watt capability to leverage our internal expertise, we are best
Telephone · +44-1628-362-000 positioned to help find your optimal solution.
Email Address · nic.talbot-watt@blackswan-analysis.co.uk
Internet Website · https://blackswan-analysis.co.uk Our areas of expertise include forecasting excellence
Social Media · LI and patient segmentation, which are supported by an
Number of Employees · 20–25 array of proprietary tools such as comprehensive epi-
Founded (year) · 2007 demiology and pricing databases.

Areas of Activity · l Forecasting Our philosophy at Black Swan is to create a collabora-


l Data analysis tive environment that enables us to provide an unparal-
l Consulting leled level of satisfaction and quality to our clients.
l Epidemiology

Our solutions
Consultancy services
At Black Swan we combine extensive clinical practice
with robust scientific research to provide in-depth in-
sight and solutions for healthcare businesses. We are
unique in developing market forecast models containing
detailed market characterisation using information from
both pathological and epidemiological sources. Our
consultancy services deliver clients the information they
need to make business decisions clear.

Epidemiology services
The Epiomic™ database is an online, evidence-based
source for patient populations in over 212 disease ar-
eas across 27 countries. Going beyond basic preva-
lence or incidence, patient populations can be seg-
mented according to clinical parameters, co-morbid
conditions, biomarkers, and more to provide an unprec-
edented level of depth. Through detailed segmentation,
these refined populations provide the fundamental
building blocks for more accurate and robust asset
valuations and forecasts.
Experts in black swan analysis

healthcare and
market forecasting
Oncology services
The Onco-Strat™ forecasting platform provides ready-
We create value built incidence-driven disease forecast models based
on the dynamic flow of patients through clinical guideline
for your business with:
specific treatment algorithms. Patients are followed
through lines of therapy, further broken down into cur-
› Early asset valuations rent and predicted clinically relevant segments. With
data across over 25 tumour types, Black Swan Analysis
› Rare disease quantification is well positioned to help forecast products looking to
obtain pan-tumor indications.

› Dynamic forecasting Drug pricing services


The RxPriceIndex™ platform was designed with the client
› Robust sourcing and transparency in mind in order to support business decisions with ac-
curate and reliable pharmaceutical pricing information.
› Continuous analyst support
Access to historical pricing information beginning from
June 2015 enables you to understand and plot the Eu-
ropean market environment. This can be done by plot-
ting launch order across markets, uncovering generic
market entry specific to first country of launch, and price
erosion for the branded product in that country.

The platform displays the ex-factory, wholesaler, phar-


macy, and retail price by using country-specific margins
and mark-ups that have been verified by a panel of ex-
perts.

At Black Swan we are all about making business decisions


clear with extensive data that can be customised and is
easy to use. Access a range of free-to-download white-
papers on our website www.blackswan-analysis.co.uk.

10th european biotechnology guide 2020 46 | 47


Name · Boehringer Ingelheim Company profile
Biopharmaceuticals GmbH The Boehringer Ingelheim group is one of the world’s 20
leading pharmaceutical companies. Headquartered in
Address/P.O. Box · Binger Strasse 173 Ingelheim, Germany, it operates globally with 176 affili-
Postal Code/City · 55216 Ingelheim ates and more than 50,000 employees. Since it was
Country · Germany founded in 1885, the family-owned company has been
Contact Person · Matthias Reinig committed to researching, developing, manufacturing,
Telephone · +49-6132-77-0 and marketing novel medications of high therapeutic
Fax · +49-6132-72-0 value for human and veterinary medicine.
Email · bioxcellence@boehringer-ingelheim.com
Website · www.bioxcellence.com In 2018, Boehringer Ingelheim achieved net sales of
Number of Employees · more than 50,000 in 2018 about 17.5 billion euros.
Founded (year) · 1885 in Ingelheim, Germany
Type of Laboratory · S1 Boehringer Ingelheim BioXcellence™ is a leading bio-
pharmaceutical contract manufacturer — a preferred
Areas of Activity · Focus on human pharmaceuticals, partner providing the entire production chain from DNA
animal health and biopharmaceutical to Fill & Finish. With over 35 years of biotechnology ex-
contract manufacturing perience, more than 3,600 dedicated and highly trained
employees, and a global network we have helped our
Net Sales · €17,500 million in 2018 customers to bring more than 35 biologics to the market.
Relevant R&D Budget · €3,200 million in 2018 We have also transferred and optimised more than 150
development and manufacturing projects at all stages
Request for · Boehringer Ingelheim BioXcellence™ from our customers to our facilities, as well as within our
Further Collaborations seeks companies in need of biopharma network. We work with 15 of the world’s Top 20 pharma
development and GMP manufacturing and many innovative biotech companies in getting the
services and helps customers to get right treatments and therapies to patients.
their products to market on time.

Wherever you are, we are by your side.


Our network of manufacturing facilities spans the globe,
from Fremont, California in the United States to Biberach
in Germany, Vienna in Austria, and Shanghai in China.
From these sites, we provide business functions any-
where in the world, offering our customers first-class
biopharmaceutical medicines and the best-suited busi-
ness model and production site for their needs:

Global capacity for cell culture:


> 290 kL commercial

Global capacity for microbials and yeast fermentation:


> 12 kL commercial
Boehringer Ingelheim

We deliver progress. And it’s our pleasure.


We are the preferred partner and single supplier for the
production of biopharmaceutical medicines, ranging from
mammalian cell cultures to microbial and yeast fermenta-
tions. We have comprehensive experience with a variety
of different host cells, producing an equally broad vari-
ety of molecules according to cGMP manufacturing
guidelines and covering all stages of development includ-
ing Fill & Finish. Our focus is on producing value for our
customers with robust processes, optimal preparation
for launch, and global commercial supplies.

We treat your products as if they were


our own.
Aside from our extensive experience and technical ex-
pertise, there are several other good reasons to choose
us as your trusted contract manufacturing partner:
·· Pharma mindset and traditional values
·· Long-term view on customer partnerships
·· Independent contract manufacturing organisation
within a large corporation
·· Constantly expanding global capacities and capa-
bilities
·· Excellent global regulatory track record
·· Roughly 50% of our customers have trusted us for
more than 15 years

10th european biotechnology guide 2020 48 | 49


Name · Distretto Tecnologico Campania Distretto Tecnologico Campania Bioscience is a re-
Bioscience scarl gional cluster based in Naples (Campania region –
Southern Italy) that gathers together the competences
Head office: and facilities of 8 international research organisations
Address/P.O. Box · Via L. De Crecchio, 7 and 52 companies (12 big, 15 medium, 25 small enter-
Postal Code/City · 80138 Naples prises) operating in the fields of health, biotech, and
Telephone · +39-81-5667677 agri-food.
Country · Italy
Campania Bioscience manages large-scale scientific
Field office: and technological research projects on innovative prod-
Address/P.O. Box · Via T. De Amicis, 95 ucts and services, supports business development and
Postal Code/City · 80145 Naples the creation of innovative startups, promotes the access
Telephone · +39-81-679883/84 of companies to dedicated finance, and trains highly
Country · Italy qualified professionals in the field of life sciences.

Contact Persons · Roberta Lauro, Rino Prota Campania Bioscience’s main activities are focused on:
Fax · +39-0815667677 ·· Widespread animation of the Cluster to facilitate col-
Email · r.lauro@campaniabioscience.it laboration, knowledge sharing, and the provision of
rino.prota@campaniabioscience.it specialised business support services (e.g. market
Website · www.campaniabioscience.it analysis, partnership building, monitoring of funding
Founded (year) · 2013 opportunities)
Areas of Activity · l Industrial Biotechnologies ·· Marketing of the Cluster to increase participation of
l Innovative Technologies for the new undertakings or organisations at the local/re-
Biomedical Industry gional level to increase the competitiveness, innova-
l Oncology tion and visibility of the Campania life sciences eco-
l New Therapies system
l Genetics and Genomics ·· Participation in innovation and R&D projects at the
l Cosmeceuticals, Nutraceuticals, and regional/national/EU level
Functional Foods ·· Enabling Cluster members to share facilities (both
External · l ALISEI – Italy’s Life Science Cluster within and beyond the Cluster)
Collaborations l Council of European Bioregions ·· Planning and implementation of training initiatives,
l European Biotechnology Network workshops, and round tables, to foster knowledge
Request for · Campania Bioscience is strongly sharing and networking. Campania Bioscience has
Further Collaborations interested in: inherited some remarkable experience from its mem-
l exploring opportunities for bers in internationalisation campaigns within and
cooperation with other EU clusters/ beyond the EU (some of its members are significantly
companies/research centres for involved in business missions outside the EU).
technology/research/business
cooperation Campania Bioscience is also strongly committed to fos-
l fi
 nding partners for joining EU projects tering the internationalisation strategy led by the Italian
l exchanging best practices National Cluster for Life Sciences (ALISEI). Campania
Bioscience participates in some international networks
European such as the European Biotechnology Network (EBN)
Member of Biotechnology and the Council of European Bioregions (CEBR).
NET WORK
Campania Bioscience

Technological trajectories and projects


Campania Bioscience is responsible for the manage-
ment and implementation of several R&D projects, with
an overall value of €70 million, split as follows:

Pharmaceuticals, design, and testing of new therapies


·· New therapies for the treatment of high-impact dis-
eases – SATIN (€15m)
·· Productive bioprocesses for molecules of pharma-
ceutical interest (€7m)

Innovative dianostic tools for the biomedical industry


·· New diagnostic approaches for high-impact dis-
eases Id SHARID €9m – PROSCAN (€8m)
·· Genetic-molecular traceability and food monitoring
(€5m)
·· Medical devices for tissue regeneration (€6m)

Design and production of


cosmeceuticals and nutraceuticals
·· Formulations of functional food for metabolic and
cardiovascular pathologies (€7m)
·· Delivery systems for the release of micro-molecules
encapsulated with cosmeceuticals and nutraceuticals
(€6m)

Critical infrastructure protection


·· Enzyme formulations for decontamination of critical
infrastructure – SME-INST.

Supporting new companies in personalised health


·· GENERA Project for supporting SME internationalisa-
tion towards emerging third countries beyond Europe
– COSME CLUSTER GO International
·· INNOLABS Project for supporting cross-sectorial
SMEs – H2020 INNOSUP

10th european biotechnology guide 2020 50 | 51


Name · China Bioengineering Technology Introduction
Group Limited China Bioengineering Technology Group Limited (CBT),
situated in Hong Kong, is a high-tech, professional, and
Address/P.O. Box · Rm 202, Premier Centre, well-recognised body working on biomedical science
Lai Chi Kok, Kowloon and precision medicine, as well as big data access, sta-
Postal Code/City · Hong Kong tistics, and analysis. Our company possesses Independ-
Country · China ent Intellectual Property Rights for our genetic-testing
Contact Person · Dr Jay Liang technology and biomedical data analysis platform. In
Telephone · +852-2208-7900 addition, we are the pioneer in Hong Kong in using the
Email Address · info@cbtgene.hk Simoa HD-1 Analyzer to detect proteins and nucleic acid
Internet Website · www.cbtgene.com.hk in serum and plasma. It is a fully automatic instrument for
Number of Employees · 20 running immunoassays with ultrahigh sensitivity.
Founded (year) · 2015
Products & services
Areas of Activity · l Gene testing CBT is introducing new genetic applications that have the
l Single molecular assay potential to aid in daily personal medication, disease pre-
l Disease risk testing vention, nutrition & exercise, intelligence development,
and other related domains in Hong Kong and mainland
(as of 2019) China. Simoa technology can facilitate early diagnosis
of cancers, infectious diseases, immune inflammations,
neurological diseases, and cardiovascular diseases. It
also contributes to the development of new biomarkers
for in vitro and concomitant diagnoses. Combining ge-
netic data with biomarker data, CBT could produce more
valuable and comprehensive research results.

Whole genome test


The CBT GeneHealth Whole Genome Test includes
detection of genes associated with disease suscep-
tibility, individual traits, drug response, nutrition, and
other areas. Utilising internationally recognised gold
standard sequencing technology and high-throughput
gene chips together with a high-volume database and
analysis system, we provide customers with premium
whole genome detection services and immediate results
delivered directly to you.
The CBT GeneHealth Whole Genome Test consists of
500+ items including 120+ risk factors for disease, 110+
characteristics, and 270+ drug reactions.

Single molecular assay (Simoa)


We are on a mission to change the way in which health-
European care is provided by giving researchers the ability to
Member of Biotechnology closely examine the continuum from health to disease.
NET WORK
CBT

Oncology
Measuring biomarkers at every stage of tumour devel-
opment: The ability to detect oncology biomarkers at
ultra-low levels has the potential to enable new options
for diagnostics and treatment in cancer research. Simoa
assays have the potential to be used to monitor cancer
risk, identify early-stage cancers, and discriminate be-
tween benign and malignant cells.

Neurology
Advancing CNS (central nervous system) biomarker detec-
tion: The ability to detect neurological biomarkers, which
have traditionally only been detectable in cerebrospinal
fluid, at ultra-low levels has the potential to transform the
way brain injuries and diseases are diagnosed. Simoa as-
says can detect neurological biomarkers associated with
brain injury and disease at much earlier stages to under-
stand the long-term effects and disease pathology.

Cardiology
Powering advancements in heart health: The ability
to detect cardiac biomarkers at ultra-low levels is ad-
vancing the future of heart health. Simoa assays have
the potential to detect cardiac biomarkers, which are
instrumental for predicting major adverse cardiovascular
events, development of heart failure, or transition to end-
stage kidney disease, earlier than ever before.

Inflammatory markers
Measuring inflammatory markers in normal and disease
samples: Simoa assays can measure inflammatory and
anti-inflammatory molecules in serum and plasma with un-
precedented sensitivity, enabling new discoveries into the
role of inflammation in the biology of health and disease.

Infectious disease
Powering epidemic prevention: The ability to detect infec-
tious disease biomarkers before the onset of an immune
response, while a virus is most contagious and multiplying
rapidly, is critical for controlling the spread of disease.

Our vision
Reveal the secret to a healthy life – let China excel in the
world of precision medicine.

10th european biotechnology guide 2020 52 | 53


Name · Cellex CMT Manufacturing, Transport The CMT Cellex Manufacturing Transports and Logistics
and Logistics GmbH GmbH, founded in 2018, belongs to the Cellex group
of companies.
Address/P.O. Box ·
Mathias-Brüggen Str. 140
Postal Code/City ·
50829 Cologne The Cellex group offers a broad spectrum of services
Country ·
Germany for pharma, biotech, clinical, and research institutions
Contact Person ·
Ingrid Seidel in the field of cellular therapies.
Telephone ·
+49-221-4545702
Fax ·
+49-221-4545809 Our apheresis centres have all the techniques for collec-
Email Address ·
i.seidel@cellex.me tion of hematopoietic blood stem cells and lymphocytes
Internet Website ·
www.cellex.me from patients and healthy donors for clinical use and
Founded (year) ·
Company founded in 2001 research purposes.
Active in ATMP manufacturing since
2016 Our state-of-the art Cellex Cell Manufacturing Plant
2018 opening of the Cellex Cell (CCMP), based in Cologne, is the heart of CMT services
Manufacturing Plant in Cologne and offers GMP-compliant contract ATMP manufactur-
Ossendorf ing. Cellular subsets are separated, genetically modified,
Type of Laboratory · l Grade C and D cleanrooms and frozen.
l Isolators used for open manipulation
steps under clean room class A CCMP staff has expertise in cryopreservation and
conditions – S2 storage of cryopreserved products. Storage can take
l Quality control laboratories place at temperatures ≤ 140 °C in vapor phase over
l Cryo storage area liquid nitrogen in tanks with vacuum super insulation
l Additional special training facility or at – 80 °C in freezers. An alarm system monitors the
constant adherence to storage temperatures.
Areas of Activity · Full service provider with regard to
innovative cell therapies: Intermediates and final products are analysed. The qual-
l Manufacturing and storage ity control, including flow cytometry, cell count, viability,
l Logistics and scheduling blood count, etc., complies with the requirements of the
l Transports current EU and US regulations, ICH recommendations,
l Worldwide supply of cell products for and GMP guidelines.
R&D as well as within clinical trials
We import cell therapy products into the European
Specialised in transfer of activities Union, perform EU QP release, and distribute ATMPs
from academic invention to GMP- in member states.
compliant manufacturing and in
contract manufacturing of Advanced
Therapy Medicinal Products (ATMPs)

External · Large international pharmaceutical


Collaborations companies and academia.

Request for · Cellex is interested in collaborations


Further Collaborations with academic and industrial partners.
cellex

The Cellex range of services also includes scheduling


and coordination as well as AEO-certified worldwide
transportation of all cellular subsets including all related
GxP documentation.

Cellex has obtained manufacturing licences for multiple


cell therapy products for clinical applications.

All employees are highly qualified and have extensive


experience in the GMP-regulated environment. Their
training, performed on a regular basis in all GMP-relevant
areas, ensures the high standard of services and prod-
uct quality to our customers.

Our company has experience in GMP manufacturing of


autologous and allogeneic cell types, which are geneti-
cally modified with retroviral and lentiviral vectors. The
primary knowledge is for CAR-T technologies.

With a growing team of over 50 employees, we cover


project management, manufacturing, and quality control
and ensure the maintenance of our quality management
system.

10th european biotechnology guide 2020 54 | 55


Name · CellGenix GmbH High-quality GMP reagents for cell and
gene therapy manufacturing
Address/P.O. Box · Am Flughafen 16 CellGenix is a leading global supplier of high-quality raw
Postal Code/City · 79108 Freiburg and ancillary materials for the expanding market of cell
Country · Germany and gene therapy as well as regenerative medicine.
Contact Person · Prof. Dr Felicia Rosenthal
Telephone · +49-761-888 89-0 We develop, manufacture, and market human cytokines,
Fax · +49-761-888 89-800 growth factors, and other recombinant cell culture
Email Address · info@cellgenix.com components in preclinical and GMP quality, as well as
Internet Website · cellgenix.com proprietary serum-free media for further manufactur-
Social Media · I ing of ATMPs. Our products are used by academia and
Number of Employees · 60 industry partners in clinical trials and commercial manu-
Founded (year) · 1994 facturing throughout the world. As an ATMP developer
Type of Laboratory · GMP and manufacturer we have acquired in-depth cell culture
Clean Room facilities A/B/C/D knowledge and superior regulatory expertise. With this
S1/S2 unique background we understand the high require-
ments our customers face during product development
Areas of Activity · l E x vivo raw materials for and the regulatory approval process.
Cell & Gene Therapy
l Regenerative Medicine CellGenix is headquartered in Freiburg, Germany and
operates a subsidiary near Boston in Portsmouth, NH,
External · Distribution in Europe of Saint Gobain USA.
Collaborations FEP cell culture and cryopreservation
bags
Our mission & vision
Request for · l T cells Our mission is to enable and accelerate safe and ef-
Further Collaborations l MSCs ficient transition of cell, gene, and tissue-engineered
l iPSCs, ESCs products from preclinical to post-approval clinical appli-
cations for the benefit of patients worldwide. We foster
this by providing premium ancillary products, reagents,
tools, and expert regulatory support to our academic
and industry partners worldwide.

We aim to be a key provider in the fight against disease,


the preferred supplier of raw materials and tools, and a
trusted partner for large-scale manufacturing in cell and
gene therapy as well as regenerative medicine.

Our history
CellGenix has more than two decades of in-house
expertise in GMP manufacturing and the development
of products (for dendritic cells, HSC, cord blood cells,
and chondrocytes) in the field of cell and gene therapy
cellgenix

and regenerative medicine. The company was founded


CY in 1994 as a spin-off of Freiburg University Medical
TO Center and was the first European company to obtain
K
a GMP manufacturing authorisation for cell processing
I N

in 1995.
ES
&

CellGenix’s current Quality Management (QM) system


GROWTH FACT

was established for the manufacture of recombinant


protein investigational products (patient-specific
idiotype vaccines and recombinant tumour vaccines) in
compliance with GMP under manufacturing authorisa-
tion from German regulatory authorities. The QM system
has been adapted for the manufacture of recombinant
OR

raw materials and has been ISO certified since 2012


S

(currently DIN EN ISO 9001:2015).

With many years of experience in the field of cell and


gene therapy, CellGenix has always taken active inter-
est in supporting the advancement of the regulatory
framework in this evolving environment. We filed the first
SERU

FDA DMF for a cytokine as ancillary reagent in 2002 and


co-authored chapter <92> with the USP in 2010.
M-FREE

Regulatory excellence
CellGenix GMP products are based on three major
ME

A quality standards:
DI

·· Safety
Safe and qualified raw materials in compliance with
our animal-derived, component-free, and serum-free
policy.
·· GMP Compliance
Manufacturing and quality control following all ap-
plicable GMP guidelines to provide documented evi-
dence of purity, potency, consistency, and stability.
·· Regulatory Compliance & Support
GMP products are manufactured, tested, released,
and distributed under an ISO 9001:2008 certified
GM

Quality Management System and allow for safe use


PQ

in accordance with USP Chapter <1043> and Ph. Eur.


AL General Chapter 5.2.12. GMP cytokines are tested
U

ITY and released according to USP Chapter <92> as


applicable.

10th european biotechnology guide 2020 56 | 57

iotechguide_BioCom.indd 1 24.07.18 12:21


Name · CILcare A unique CRO entirely
dedicated to the hearing field
Address/P.O. Box · 378 rue du Professeur Blayac CILcare is the world’s leading CRO offering preclinical
Postal Code/City · 34080 Montpellier services and consultancy in ear disorders. Based in
Country · France Montpellier, Boston, and Paris, CILcare supports
Contact Person · Marie Peytavy pharma, medtech, nutraceutical, and veterinary indus-
Telephone · +33-7-69-74-19-05 tries to assess efficacy and safety of compounds, cell
Email Address · Marie.peytavy@cilcare.com & gene therapy, and medical devices on hearing loss,
Internet Website · www.cilcare.com tinnitus, and otic disorders.
Social Media · LI 
Number of Employees · 25 CILcare designs and performs pharmacokinetics, effi-
Founded (year) · 2014 cacy, and GLP ototoxicity studies in robust validated
Type of Laboratory · CRO with in vitro & in vivo testing animal models, combining:
platforms (GLP & non-GLP facilities)
·· Sophisticated surgical approaches for specific local
Areas of Activity · l Ear disorders: delivery, adapted to each species
l Hearing loss ·· Sampling of perilymph to assess the biodistribution
l Tinnitus of drugs in the inner ear
l Otitis ·· High throughput electrophysiology & electroacoustic
l Ototoxicity measurements
lP  reclinical studies: ·· Behavioural testing & imaging to detect tinnitus
l Efficacy ·· Histology with cochleogram, ribbon synapses count-
l Safety ing
l PK/PD ·· Specific expertise in analysis and interpretation with
lS
 upporting drug, medical devices, a large range of historical data
cell & gene therapy development
lC
 onsulting for external innovation in
the hearing field Hearing loss and tinnitus remain a
global unmet medical need
External · Strategic alliance with CBSET (MA, US) We face a future where hearing loss will concern around
Collaborations a biomedical research institute linked 1 billion people by 2050, according to the World Health
to MIT Organisation (WHO) forecast. This increasing preva-
lence, stemming from an ageing population and exces-
Request for · We partner with biotechs, medtechs, sive noise exposure, will pose a future public health
Further Collaborations and pharmaceutical industries to crisis that we cannot afford to ignore. Unaddressed
develop novel therapies for ear hearing loss has significant economic costs and serious
diseases consequences, notably for mental health: it doubles the
risk of developing dementia.

CILcare’s mission is to make hearing a priority by ac-


celerating research & development on novel therapeu-
tics to prevent and treat hearing loss and tinnitus.
cilcare

CILcare, your one-stop-shop for


external innovation in ear diseases
Based on a large industrial background, a fine under-
standing of the regulatory landscape, and a strong ex-
pertise in neurotology, we guide our clients as an end-
to-end solution provider to bring breakthrough thera-
peutics to the market:
·· Identification & ranking of the best drug candidates
for auditory indications
·· Target product profiling
·· Conduct of preclinical POC
·· Recommendations for clinical trials protocols

10th european biotechnology guide 2020 58 | 59


Name · Cobra Biologics Cobra Biologics
Centre of Excellence for ATMP Cobra Biologics is a leading international contract de-
Production- DNA and Viral Vectors velopment and manufacturing organisation (CDMO)
Address/P.O. Box · Stephenson Building providing biologics and pharmaceuticals for pre-clinical,
Postal Code/City · Keele Science Park, ST5 5SP clinical, and commercial supply.
Country · United Kingdom
Contact Person · Philip Ridley-Smith Cobra has two GMP-approved facilities in Sweden and
Telephone · +44-208-246-5895 the UK, each with specific expertise tailored to serving
Mobile · +46-60-7858-600 our customers around the world. We offer a broad range
Email Address · Philip.Ridley-Smith@cobrabio.com of integrated and stand-alone contract development
and manufacturing services for clinical trials and the
Centre of Excellence for ATMP commercial market.
Production- DNA and Microbiota
Cobra Biologics As a trusted provider and a key partner in the drug de-
Address/P.O. Box · Storjordenvägen 2 velopment and commercialisation process, we take
Postal Code/City · 864 31 Matfors pride in our manufacturing excellence and comprehen-
Country · Sweden sive range of services to the pharmaceutical and biotech
Contact Person · Alex Brownfield industries.
Telephone · +44-1782-714181
Email Address · Alex.Brownfield@cobrabio.com
Internet Website · www.cobrabio.com Expertise
Social Media · LI I Cobra is a Contract Development and Manufacturing
Number of Employees · ~200 Organisation (CDMO) supporting the global life sci-
Founded (year) · 1992 ences industry in the development and manufacture of
Areas of Activity · l Contract manufacturing proteins, DNA, viral vectors, and microbiota for clinical
l Contract development trials and commercial supply.
l GMP
l Viral vectors
l DNA Experience
l Microbiota We have a 20-year track record producing biologics and
l Technical proteins pharmaceuticals for use in pre-clinical to Phase III
l Fill finish clinical trials and commercial supply, which has given
l Advanced therapies our people a unique knowledge base as both manufac-
l Gene therapy turers and also service providers for the global life sci-
l HQ DNA ences market.
External · l CPI/Cobra/GE Healthcare –
Collaborations AAV purification system We offer a broad range of integrated and stand-alone
l Cobra/Symbiosis – development services, bespoke to individual customer
viral vector supply chain requirements, stretching from process development to
l Cobra/Pall/Cell & Gene Therapy the supply of investigational medicinal products for
Catapult – continuous manufacturing clinical trials and the commercial market.
of AAV for gene therapies
l Cobra/GE Healthcare –
next gen purification of plasmid DNA
Cobra Biologics

Excellence
Every programme complies with cGMP standards
worldwide and is conceived with an unmatched quality
derived from the know-how of Cobra’s highly qualified,
flexible, and dedicated people.

Cobra has two GMP approved facilities: in Sweden our


Microbiota Production and Fill Finish Facility in Matfors
and in the United Kingdom our Centre of Excellence for
Gene Therapy, specialising in DNA and viral vector
production, located in Keele. Our sites offer a compre-
hensive service to nurture your project from conception
to fill and finish.

Cobra takes pride in manufacturing excellence – deliver-


ing what we promise and helping our customers to de-
velop drugs for the benefit of patients.

For more information, to take a virtual tour, or to get in


touch with our team, visit: www.cobrabio.com

Contract
Manufacturing
Excellence
Comprehensive biologics and
pharmaceuticals service offering, with
multi-functional and experienced project
teams nurturing customers’ products
from pre-clinical through to clinical and
commercial manufacture within two
GMP approved facilities.

Visit our website


www.cobrabio.com

10th european biotechnology guide 2020 60 | 61


Name · CRS Clinical Research Services CRS. Experts. Early Phase.
Andernach GmbH CRS is a leading European full-service CRO in early
clinical development and has more than 40 years of
Address/P.O. Box · Rennweg 72 experience in the performance of clinical trials in healthy
Postal Code/City · 56626 Andernach volunteers and dedicated patient segments.
Country · Germany The excellent quality of CRS’s services is demonstrated
Subsidiaries · | Kiel by an outstanding track record of more than 2,000 suc-
| Berlin cessfully completed trials and numerous publications in
| Wuppertal prominent international scientific trade journals.
| Mannheim
Contact Person · Dr Volker Menschik All research units of CRS are located in the most im-
(Chief Business Officer) portant German metropolitan regions. CRS maintains
Telephone · +49-30-859-949-401 a database covering more than 50,000 entries with
Mobile · +49-151-526-416-33 healthy subjects or certain patient populations all over
Fax · +49-30-859-949-222 Germany. In addition, CRS has built up close collabo-
Email Address · volker.menschik@crs-group.de rations with numerous academic and clinical sites to
Internet Website · www.crs-group.de extend access to patients in dedicated indications, such
Social Media · IQ as cardiometabolic diseases.
Number of Employees · 250
Founded (year) · Merger 2006, Especially for settings of patient trials or complex designs,
Foundation of Legacy up to 1977 CRS provides a specific supersite concept, i. e. up to
Type of Company · Full-Service CRO four sites under one project and quality management
following the same SOP regulations. Due to the stand-
Areas of Activity · | Consultancy ardised and centralised project management, subject
| Project Management recruitment and quality control, CRS is able to handle
| Clinical Conduct multi-centre settings at highest standards.
| Quality Assurance
| Clinical Trial Supply Management CRS maintains close relationships to numerous opinion
| Medical Writing leaders and several outstanding academic institutions.
| Clinical Data Management Well established collaborations with specialised care pro-
| Statistics by external partners viders allows CRS to provide a wide range of diagnostic
| Laboratory/Bioanalytical Services tools like metabolic staging, PDFF-MRI, tissue biopsies,
by external partners or catheter investigations and many more.

In-house Capacity · 250 beds CRS Kiel is situated close to the University Hospital
Schleswig-Holstein (UKSH); the one in Berlin is close
Request for · Our Business Development team is to the famous Charité and the Federal Military Hospital.
Further Collaborations happy to discuss your project and to CRS Mannheim is located in a region that is home to
propose tailor-made solutions for the established research institutes as well as the renowned
clinical development of your product. University Hospital Heidelberg and University Medical
Please do not hesitate to contact us: Centre Mannheim (UMM).
WWW.CRS-GROUP.DE/CONTACT
CRS is regularly audited by sponsors and inspected by
the authorities (FDA, EMA, BfArM, AFSSAPS, etc.).
crs

CRS. Extensive Expertise.


Dr Torben Thomsen Dr Atef Halabi CRS is one of the leading experts in the performance of
Partner, President & Partner, Managing & all kind of first in human and early phase pharmacokinetic
Chief Executive Officer Medical Director and pharmacodynamic studies in healthy volunteers to
Proof of Concept in special indications like:

·· Renal & hepatic impairment


·· Cardiometabolic diseases
·· NASH
·· Diabetes
·· Obesity
·· Men’s & women’s health
·· Dermatology
·· Medical devices
·· Respiratory/inhalative devices
Prof. Dr Thomas Forst Ekkehard Herrmann
·· Vaccines
Chief Medical Officer Chief Financial Officer

CRS. Your CRO.


Full-service. A complete service solution out of one hand,
under one contract.

Customer-focused. Your needs and your satisfaction are


our motivation to deliver maximum performance.

Tailor-made. Our solution is individually customised


to your specific requirements. No one-size fits all ap-
Dr Volker Menschik proach.
Chief Business Officer
Shared expertise. Take advantages of more than 40
years of experience.

Small enough to be customer-centric and highly flexible


to act according to your needs.

Big enough to manage even complex and challenging


trials out of one hand.

www.crs-group.de

10th european biotechnology guide 2020 62 | 63


Name · Enantis s.r.o. About
Enantis was established as a university spin-off in 2006.
Address/P.O. Box ·Kamenice 771/34 Since then, we have been operating in the field of protein
Postal Code/City ·625 00 Brno and enzyme engineering using our vast expertise and
Country ·Czech Republic state-of-the-art software tools. This combination of exper-
Contact Person ·Alzbeta Cardova tise enables us to develop our own products with specific
(Business Development Manager) properties and also, it allows us to provide powerful and
Telephone · +420 511 205 287 unique protein optimization services to our clients.
Email Address · enantis@enantis.com Enantis was the first Czech biotech company which suc-
Internet Website · www.enantis.com ceeded in both phases of highly prestigious Horizon 2020
Social Media · L I SME Instrument programme.
Number of Employees · 13
Founded (year) · 2006
Type of Laboratory · l Molecular biology Protein Pro Team
l Protein chemistry We have a great deal of protein engineering experience
l Cell culture and cell analysis (protein chemistry, biotechnology, and bioinformatics).
Mutant proteins and enzymes are designed based on
Areas of Activity · l Protein engineering our robust analysis, where we combine in silico energy
l Computer-aided protein design predictions with our know-how in protein structure evo-
l Protein production and lution. As a result, just a handful of mutant proteins are
characterisation created instead of thousands. This in turn reduces the
l Protein formulation time and cost of screening and allows us to quickly
come up with the best mutants. We are able to improve
Biological Patents · l Thermostable fgf2 polypeptide, protein or enzyme thermostability, activity, selectivity,
use thereof and specificity.

Fibroblast growth factors


Our research activities focus on the family of fibroblast
growth factors (FGFs), with the goal of improving their
poor stability. Using our optimisation platform, we have
been able to dramatically improve the stability of FGF2
(bFGF). Full biological activity of our FGF2-STAB® is
retained while its standard half-life in human cell cul-
tures has increased more than 20 times in contrast to
its native counterpart. We are tirelessly working to
change the way stem cells are being cultivated through
a global FGF2-STAB® distribution deal we have in place.
Also, we are exploring other fields where our stable
FGF2 can help society – we are running preclinical tests
for wound healing application, and developing the for-
mulation of skin-care products in cosmetics. We have
European more FGFs in our portfolio with the goal of commercial-
Member of Biotechnology ising them based on the needs of the market.
NET WORK
enantis

Haloalkane dehalogenases
We are the world’s only supplier of recombinant and
engineered haloalkane dehalogenases. Dehalogenases
are robust catalysts that do not require any co-factors,
can be immobilised, and are engineered for higher activ-
ity, enantioselectivity, thermal stability, and resistance
to organic solvents. The members of this family have a
great potential for the biocatalytic preparation of opti-
cally pure compounds, bioremediation of environmental
pollutants, and decontamination of chemical agents.

Software
We are able to license out our proprietary software to
other commercial partners. We have a close collabora-
tion with Loschmidt Laboratories at Masaryk University,
Brno, Czech Republic, where state-of-the-art software
is being developed, and we are the sole source of the
following protein engineering software: HotSpot Wizard,
Caver Web, Caver Dock, and FireProt.

Services
Our expertise in protein engineering allows us to offer
our know-how to partners in the form of contract re-
search. We work on a confidential basis under CDA and/
or MTA and respect the IP and know-how of our partners.
Alternatively, we can collaborate in a mode of joint re-
search. Once we know all the info about the project and
the molecule, we run the first free-of-charge round of in
silico analysis to identify the feasibility of the tailored-
designed protein property (such as stability, activity,
etc.). Then we work on a pre-agreed milestone basis to
satisfy the project needs.

10th european biotechnology guide 2020 64 | 65


Name · Enzymicals AG Enzymicals AG
Enzymes I Chemicals I Solutions
Address/P.O. Box · Walther-Rathenau-Str. 49a Enzymicals is your experienced partner for biocatalytic
Postal Code/City · 17489 Greifswald synthesis. An interdisciplinary team of 18 scientists
Country · Germany and technicians is currently engaged in providing
Contact Person · Dr Rainer Wardenga integrated solutions for industrial biocatalysis. The
Telephone · +49-3834-515470 focus of the independent SME is the development and
Fax · +49-3834-515473 scale-up of robust chemo-biocatalytic processes for
Email Address · info@enzymicals.com the production of fine and specialty chemicals as well
Internet Website · www.enzymicals.com as the development and production of enzymes and
Social Media · I the chemo-biocatalytic synthesis of fine and specialty
Number of Employees · 18 chemicals on customer demand. These core areas are
Founded (year) · 2009 combined to realise tailor-made solutions for custom
Type of Laboratory · l S1 Biotech development and manufacturing. Our continuous activi-
l Chemistry & Analytics ties in academic partnering and industrial collaborations
l Process Engineering results in the delivery of state-of-the-art concepts which
l K ilo Lab & Small-Scale Manufacturing are applicable at commercial scale.

Areas of Activity · l Development and scale up of


chemoenzymatic processes incl. DSP Products & Services
l Customer specific solutions in Individual process solutions, tailor-made enzymes and
enzyme technology and customised chemicals
biotransformation Dedicated to designing, developing and implementing
l Development and production of innovative, cost-effective, and scalable chemo-biocat-
enzymes alytic routes to fine chemicals & APIs, Enzymicals offers
l Tailor-made fine chemicals, recognised expertise in the use of enzymatic processes
intermediates and APIs for complex chemical synthesis. We develop scalable
strategies for the synthesis of your desired compound,
Biological Patents · IP protected by international patent which includes feasibility studies as well as develop-
applications and granted patents ment and scale-up of the process, inclusive DSP. For
this we are able to combine efficient enzymatic and
External · l Stakeholders networks chemical synthesis steps.
Collaborations l 4-chiral Network
www.4chiral.de/de/start Enzymicals is an outstanding resource of enzymes
l CMO and CDMO network suitable for diagnostics, research, and development as
l Broad international academic well as for commercial production. Our enzyme portfolio
R&D collaborations contains a continually expanding biocatalytic toolbox,
with innovative biocatalysts from the class of e.g.
transaminases, monooxygenases, halohydrin dehalo-
genases, imine reductases, and hydrolases at desired
quality grades to solve customer-specific demands at
best performance. Selected products are incorporated
in our online-catalogue.
enzymicals

We deliver concept-to-completion comprehensive


solutions to create high-performance products based
on chemo-enzymatic processes. For this, we discover
and produce enzymes based on the demands of our
customers and partners. Our technology platform cov-
ers the identification of suitable catalysts from strain or
enzyme collections, databases, or metagenome libraries
as well their functional expression in a range of micro-
bial host systems. This enables us to offer tailor-made
protein expression and optimisation as a service. Thus
almost any biocatalyst of interest can be supplied on
an analytical and commercial scale. Within our network
we provide processes in up to 85 cbm fermenters or for
chemical products in multi kilogram or ton scale equip-
ment. A catalyst suitable for the production of your target
compound can be optimised via our protein engineering
technology to provide the best performance available.

Together with our network partners, we have expanded


our service to ASMF filing, regulatory affairs, cGMP pro-
duction, and bulk scale supply. The combination of best
catalysts with optimised chemistry and the integration
of processing aspects have enabled us to increase the
speed of delivery of effective solutions.

Management
Dr Ulf Menyes (CEO)

10th european biotechnology guide 2020 66 | 67


Name · EphyX Neuroscience Need to test your compounds on
reliable, functional assays?
Address/P.O. Box · 7 Allée de Chartres For neurology-related preclinical studies, electrophys-
Postal Code/City · 33 000, Bordeaux iology is the best way.
Country · France Located in the heart of Bordeaux in France, EphyX
Contact Person · Txomin Lalanne, President Neuroscience has the expertise, state-of-the-art equip-
Telephone · +33-7-859330-21 ment, and specialised facilities that enable it to deliver
Email Address · txomin.lalanne@ephyx-neuroscience.com reliable neuroscience research services centred on in
Internet Website · www.ephyx-neuroscience.com vitro electrophysiology. This approach provides critical
Founded (year) · 2018 functional data that are key to understanding a com-
pound’s efficacy and mechanisms of action in a physi-
Areas of Activity · l Electrophysiology ological context. EphyX Neuroscience hones the capa-
l CNS bility to provide a clear and detailed picture of the effects
l Preclinical of various compounds on neuronal physiology, from
l iPSCs brain circuits to single ion channels.

Make your preclinical study more


human: iPSC-derived neurons
EphyX Neuroscience is particularly recognised for its
routine use of human iPSC (induced pluripotent stem
cells)-derived neuronal cultures. By combining electro-
physiology and human cells at preclinical stages, EphyX
is leading the charge in the industry to tackle a key issue
in neuroscience-related pharmaceutical development:
cross-species differences. Providing functional data on
human tissues is a specificity that allows EphyX to arm
its clients with the most relevant data obtained in
highly physiological conditions, allowing them to opti-
mise the selection of compounds before the next
stages, thus drastically reducing the risk of failure.

Human neuronal cultures present a very well character-


ised genome and allow the acquisition of very reproduc-
ible data. iPSCs may come from healthy patients as well
as from patients suffering from a specific pathology
(Alzheimer’s, Parkinson’s, Huntington’s, Fragile X, etc.),
making these cultures the ideal preclinical model to test
your compounds in the most “real-world” and therefore
reliable conditions.

European
Member of Biotechnology
NET WORK
ephyx neuroscience

Our services
EphyX is specialised in in vitro electrophysiology. We
employ various highly reliable and physiological prepa-
rations:

In vitro
·· Rodent acute slices
·· Rodent neuronal dissociated cultures
·· Human iPSC-derived neuronal cultures

In vivo
We also work in close collaboration with a partner on
site allowing us to provide key in vivo data to perfectly
complement our in vitro approach:
·· Single and multi-unit recordings in awake or anaes-
thetised rodents.
·· Vast panel of state-of-the-art behavioural tests.

10th european biotechnology guide 2020 68 | 69


Name · ERBC ERBC – the non-clinical engine
(European Research Biology Center) ERBC has been created in 2019 by the merger of two
reference CROs in pharmacology and toxicology cre-
Address/P.O. Box · Headquarters: Chemin de Montifault ated in the 70’s: CERB, France and RTC, Italy.
Postal Code/City · 18800 Baugy ERBC is now a European leader in non-clinical studies
Country · France to de-risk innovation and improve R&D productivity,
Contact Person · Frank Visser (Chief Commercial Officer) offering all services from non-clinical proof-of-concept
Telephone · +39-06-91095263 to market of any type of drug-candidate or chemical
Fax · +39-06-9122233 compound:
Email Address · fvisser@erbc-group.com ·· Comprehensive suite of experimental capabilities,
Internet Website · www.erbc-group.com preclinical models, regulatory pre-IND package and
Social Media · I consultancy services
Number of Employees · 240 ·· Multidisciplinary team of experts (>200 FTE), includ-
Founded (year) · 1973 ing leaders in safety cardiology, DART, electrophys-
Type of Laboratory · Translational research, safety iology and pathophysiology
pharmacology, toxicology, from routine ·· >15,000 sqm facilities, with more than half dedicated
analysis to highly complex and to laboratories and animal housing
customized studies ·· Deeply engaged in animal ethics and welfare

Areas of Activity · l New Chemical Entity Every year, study reports from our two Centres are suc-
l Oligonucleotide cessfully used in support of market authorization and new
l Protein product approval submissions around the world, includ-
l Peptide ing the European (EMA, ECHA), US (FDA and EPA) and
l Monoclonal antibody Japanese (MHLW and MAFF) regulatory authorities.
l Vaccine Investment in outstanding scientific and technical man-
l Cellular therapy power, high-tech equipment and facilities are crucial
l Gene therapy cornerstones of our growth. The quality and reliability
l Excipient of our performance is reflected by the many ongoing
l Chemicals and long-lasting collaborations we maintain with leading
l Biocide international pharmaceutical and chemical companies.
l Plant protection products We innovate with 5 to 10 new models or methodological
l Food & Feed procedures every year.

External · Collaborations with pharmaceutical,


Collaborations biotech, chemical companies and Translational research
CROs, from preclinical proof of concept With over 200 validated methods and models, a facili-
to market tated access to patient samples and a world class aca-
demic and industrial network, ERBC is uniquely posi-
Request for · Our business development team is tioned to establish the preclinical proof-of-concept of
Further Collaborations happy to discuss your project and find any therapies.
tailor-made solutions for you challeng-
es. Please do not hesitate to contact
us at info@erbc-group.com
All animal models erbc

Safety pharmacology
Over the past 40 years, ERBC has become a leader in
safety pharmacology, conducting annually more than 400
non GLP or GLP-compliant safety pharmacology studies.

Core battery
·· Effect of the drug on vital functions in rodent and
non-rodent species

Follow-up studies
·· Cardiovascular System
·· Respiratory System
·· Central Nervous System
·· Autonomic Nervous System
·· Renal/Urinary System
·· Gastrointestinal System
·· Other Systems (immune, endocrine and hepatic func-
tions)
All routes of administration
Toxicology
ERBC offers a full range of services covering from ex-
ploratory programs to fully GLP-compliant toxicology
studies. The latter range from acute to chronic toxicity,
Conventional with different species and multiple routes of administra-
• Oral tion, to specialty toxicology.
• Intranasal ·· General Toxicology
·· Developmental & reproductive toxicology (DART)
• Intravenous bolus Advanced ·· Neonatal and juvenile toxicology
• Subcutaneous • Intratracheal ·· Endocrine toxicology
• Dermal • Continuous intravenous ·· Genetic toxicology
• Intradermal infusion ·· Carcinogenicity
• Intramuscular • Intra-duodenal ·· In vitro toxicology
• Intraperitoneal ·· Cardiotoxicity
• Intra-hepatic
·· Local tolerance
• Intravaginal • Intra-urethral ·· Immunotoxicology
• Intrarectal • Ocular (subretinal
• Intravascular and intravitreal)
• Ocular instillation • Cerebral
(stereotaxia)
• Intratechal
(cisterna magna)
• Intra-articular

10th european biotechnology guide 2020 70 | 71


Name · Eurasanté Eurasanté – one of the best innovative
hubs for biotech in Europe
Address/P.O. Box · 310 Avenue Eugène Avinée Eurasanté is a technology transfer tool, an incubator, an
Postal Code/City · 59120, Loos accelerator, and a cluster manager in the health field in
Country · France Northern France. Eurasanté assists French and foreign
Contact Person · Margaux Satola companies, entrepreneurs, scientists, and clinicians in
Telephone · +33-3-28-55-90-60 their innovation and development projects.
Email Address · msatola@eurasante.com
Internet Website · https://lille.eurasante.com/ The region includes over 1,100 healthcare companies
Social Media · LI with 31,700 employees in this sector. Their strengths are
Number of Employees · 81 in neurodegenerative diseases, cardiometabolic dis-
Founded (year) · 1994 eases, and medical chemistry.

Areas of Activity · l Tech transfer Eurasanté also promotes and develops the Eurasanté
l Business development Bio-business Park, which hosts 8 hospitals, 4 universi-
l Life sciences ties, 7 specialised schools, 170 companies, and 50
l Biology laboratories within a European-wide scientific and
l Health medical site.
l Nutrition
Eurasanté fosters technology transfer and collaborative
projects and supports the emergence of start-ups and
spin-offs. Two programmes have been created to
stimulate the creation of start-ups: the Eurasanté Bio
Incubator and Accelerator. They provide a range of
services and expertise to help international start-ups
wishing to penetrate the European healthcare market
and to join an ecosystem among the most fertile in Eu-
rope. The Eurasanté Bio Incubator is ranked among the
top 20 best European incubators fostering biotech start-
ups development (Labiotech.eu 2019). Since its creation
in 2000, the Eurasanté Bio Incubator has accompanied
180 projects, helped the creation of 110 start-ups that
generated 1,300 jobs, and raised €400 million equity.

Eurasanté facilitates the relocation of companies,


whether they plan to expand or to create a new activity
in France, and gives access to investment funds dedi-
cated to innovative start-ups: CAPTECH and French Tech
Seed. These investment funds strengthen co-investment,
by providing support of up to €3 million equity per project
in search of funding. For biotech start-ups wishing to start
clinical trials, the funding needs can be supported
through new fundraising, closed thanks to the public and
private investors involved in the investment funds.
eurasanté

BIOFIT
The leading European partnering event for early-stage
deals and investment rounds in the field of life sciences
Eurasanté also organises four international healthcare-
related partnering events that aim to increase and im-
prove interaction between academia and industry,
among them: BioFIT (Life Sciences), MedFIT (Medtech,
Diagnostic, Digital Health), NutrEvent (Food, Feed, Nutri-
tion, Health) and AgeingFit (Healthy Ageing).

As one of the top three European business conventions


thanks to its record figures, BioFIT is the leading partner-
ing event in Europe for technology transfer, academia-
industry collaborations, and early-stage innovation
deals in the field of Life Sciences. BioFIT is also the
European marketplace for pre-seed, seed, and Series
A investment in Life Sciences. During its previous edition
(8th), BioFIT welcomed more than 1,200 international key
players from 35 countries, such as Big Pharma, emerg-
ing and small biotech companies, diagnostic compa-
nies, pre-seed / seed / Series A investors, as well as
professionals from tech transfer, academia, and re-
search institutions.

BioFIT provides the ideal environment for academia and


industry actors to build partnerships, to source innova-
tive and competitive early-stage R&D projects, to facili-
tate the emergence of collaborative projects, to increase
licensing opportunities, to obtain funding, and to facili-
tate market access.

For more information and registration, please visit:


www.biofit-event.com

Pictures: 1, 2 + 4 by Richard Baron, 3 by Vincent Eschmann

10th european biotechnology guide 2020 72 | 73


Name · Eurofins BioPharma Product Testing Global BioPharma Product Testing
Munich GmbH within your reach

Address/P.O. Box · Behringstraße 6–8 As the largest international network of harmonised


Postal Code/City · 82152 Planegg near Munich GMP product testing labs, Eurofins BioPharma Prod-
Country · Germany uct Testing delivers a true local service experience.
Contact Person · Dr Bettina Katterle
Telephone · +49-89-899-650-0 Eurofins BioPharma Product Testing offers the most
Fax · +49-89-899-650-11 complete range of testing services, harmonised qual-
Email · info-munich@eurofins.com ity systems, and LIMS to more than 2,000 pharmaceu-
Website · www.eurofins.com/pharma-services tical and biopharmaceutical companies worldwide.
Founded (year) · 1984
Type of Laboratory · GMP/GLP Facilities
In our world, global is local
Areas of Activity · Testing services for bio-/ Our local presence ensures personal service backed by
pharmaceutical and medical device a unique global breadth of harmonised capabilities that
companies support all functional areas of bio/pharmaceutical drug
development and manufacturing, including method
External · BSL BIOSERVICE development, microbiology, process validation, and
Collaborations Scientific Laboratories Munich GmbH quality control.

With a global capacity of more than 150,000 square


metres and 35 facilities located in Australia, Belgium,
Canada, Denmark, France, Germany, India, Ireland, Italy,
Japan, Netherlands, New Zealand, Spain, Sweden, Swit-
zerland, UK, and the US, our network of GMP laboratories
and vast experience allow us to support projects of any
size from conception to market. Furthermore, we have
teams of scientists placed at more than 70 client facilities
worldwide through our award-winning Professional Sci-
entific Services® (PSS) insourcing programme.

Experience our expertise


Eurofins BioPharma Product Testing offers complete
testing services for the pharma and biopharma indus-
tries, including all starting materials, process intermedi-
ates, drug substances, drug products, and manufactur-
ing support, as well as broad technical expertise in Bio-
chemistry, Molecular & Cell Biology, Virology, Chemis-
try, and Microbiology.

Our focus in Germany lies on bioassays/Biacore, micro-


biology, in vitro toxicology, and immuno- and bioana-
Eurofins
Biopharma Product testing

lytical studies. Additionally we work in close cooperation


with BSL BIOSERVICE Munich, an internationaly active
contract research organisation, to assess biological
safety and activity of bio-/pharmaceuticals and medical
devices.

Our services at a glance


·· Toxicology/Pharmacology/Biocompatibility
·· Bioanalytics
·· Immunoanalytics
·· Bio-/Pharmaceutical Lot Release and Stability Testing
(GMP)
·· Microbiology
·· Bioassays/Biacore

In addition we offer the flexibility to manage your testing


programmes more efficiently with a choice of three
unique service models, including our award-winning
Professional Scientific Services ® (PSS), Full Time
Equivalent (FTE), or traditional fee-for-service. You can
choose the best, most cost-effective service solution
for your project goals.

International presence means global


regulatory compliance
Operating under the same strict quality procedures, our
worldwide laboratories offer a broad range of method-
ologies under GMP authorisation, ISO 17025 accredita-
tion, and ISO 9000 certification, and all analyses are
performed according to European and British Pharma-
copeia (EP), United States Pharmacopeia (USP), and
Japanese Pharmacopeia (JP), as well as specific cus-
tomer methods.

Our philosophy
Our fundamental philosophy is to help clients efficiently
allocate their research and manufacturing expenditures
by strategically engaging with them to meet their unique
outsourcing needs.

10th european biotechnology guide 2020 74 | 75


Name · EuroJobsites Ltd. EuroScienceJobs
Since 2007, EuroScienceJobs has been advertising
Address/P.O. Box · Unit 8, Kingsmill Business Park, hundreds of job opportunities for scientific researchers
Chapel Mill Rd. and postdocs. Universities, research centres, compa-
Postal Code/City · KT1 3GZ nies, government and international organisations recruit
Country · United Kingdom scientists through EuroScienceJobs.
Contact Person · Lars Peter Svane
Telephone · +44-20-3608-8800 International science researchers and other experts who
Fax · +32-2-790-32-00 can work in English are often willing to move abroad for
Email Address · info@eurojobsites.com the right opportunity in precisely their field.
Internet Website · EuroJobsites.com
Social Media · FL I Every week, we send the EuroScienceJobs Newsletter
Number of Employees · 20 to over 27,000 subscribers. Over 12,000 job alerts sub-
Founded (year) · 2003 scribers receive over 30,000 alerts every week. These
highly specialised jobseekers often share the extremely
Areas of Activity · Research Scientist and targeted e-mails with colleagues, friends from univer-
Pharma Expert Jobsites sity, and others with the same skills.

Nearly 70% of EuroScienceJobs’ users have a PhD


in science, in areas such as biochemistry, molecular
biology, microbiology, biotechnology, biostatistics, and
bioinformatics, as well as in medicine, immunology,
toxicology, and pharma. This is one of the reasons we
also launched EuroPharmaJobs six years ago. With over
3,500 LinkedIN followers, around 4,500 Facebook fol-
lowers and over 1,000 Twitter followers, your job ads are
also shared through EuroScienceJobs social media.

EuroScienceJobs has advertisers ranging from interna-


tional organisations like the European Patent Office (EPO),
the European Molecular Biology Laboratory (EMBL), na-
tional centres of research such as the Austrian Academy
of Sciences’ Ce-M-M-Centre for Molecular Medicine, and
Belgium’s CISTIM – Center for Innovation and Stimulation
of Drug Discovery to hundreds of European universities
announcing their PostDocs on EuroScienceJobs. Phar-
maceutical and biotech companies ranging from Abbott,
to Astellas, GSK, Janssen/Johnson & Johnson to Novo
Nordisk also use EuroScienceJobs to find researchers
through job ads and CV searches.

Over 5,000 research scientists are registered in the


EuroScienceJobs CV database, plus thousands of other
STEM candidates.
eurosciencejobs
europharmajobs

EuroPharmaJobs
EuroPharmaJobs is focused on Regulatory Affairs,
Clinical Trials, Biotechnology, Pharmacovigilance, Qual-
ity Assurance, as well as many other types of pharma
industry jobs.

EuroPharmaJobs reaches candidates all over Europe


working in the pharmaceutical industry. Candidates have
technical skills such as Clinical Research, Clinical Trials,
Medicine, Regulatory Affairs, Quality Assurance, Market
Access, and more general business competencies.

Advertisers include pharmaceutical and biotech com-


panies such as Fresenius KABI, Astra Zeneca, Ther-
moFisher Scientific, GSK, Roche, MSD, Novo Nordisk,
and Astellas, as well as organisations such as the Euro-
pean Patent Office (EPO) and the European Directorate
for the Quality of Medicines and Healthcare.

EuroPharmaJobs has over 15,000 visits every month,


over 6,000 weekly newsletter subscribers, and every
week more than 12,000 job alerts are sent to subscribers.
The EuroPharmaJobs Facebook group has over 7,500
followers, plus hundreds of twitter and LinkedIn follow-
ers, so your job ads will be shared widely. Thousands of
candidates are registered in the CV database.

EuroScienceJobs – Areas of interest


Biology
Chemistry
Biotechnology
Molecular Biology
Engineering
Medicine
Biochemistry
Environment
Pharmaceutical
Nano-Technology
Physics
Microbiology
Earth Science
0% 10% 20% 30% 40% 50% 60%

10th european biotechnology guide 2020 76 | 77


Name · Euronext Euronext is the leading pan-European exchange, cover-
ing Belgium, France, Ireland, the Netherlands, Norway,
Address/P.O. Box · 14 place des Reflets Portugal, and the UK. With close to 1,500 listed issuers
Postal Code/City · 92054 Paris La Défense worth €4.5 trillion in market capitalisation as of end
Country · France December 2019, Euronext has an unmatched blue chip
Contact Person · Mathieu Jalvé franchise that includes 26 issuers in the Morningstar ®
Telephone · +33-1-70-48-24-56 Eurozone 50 IndexSM and a strong diverse domestic and
Email Address · euronextinfo@euronext.com international client base. Euronext operates regulated
Internet Website · www.euronext.com and transparent equity and derivatives markets and is
Social Media · LI the largest centre for debt and funds listings in the world.
Number of Employees · 1,000+ In addition to its main regulated market, Euronext also
Founded (year) · 2000 operates Euronext GrowthTM and Euronext AccessTM,
simplifying access to listing for SMEs. The Norwegian
Areas of Activity · Finance stock exchange and its clearing & settlement subsidiary,
together operating as Oslo Børs VPS, joined Euronext
on 17 June 2019.

The leading European stock exchange


for biotechnology
The listing venue of choice for biotech companies
·· 63 biotech companies
·· €30.5bn market capitalisation
·· €29.9bn traded over the last 12 months
·· €29m average amount raised at IPO since 2015
·· +69% performance of the Next Biotech index since
2015

A wide pool of 1500+ institutional investors


Listed companies gain access to a rich ecosystem focused
on the Tech sector, with a large and international investor
base financing all growth profiles of Tech companies.

A specialised market for specialised investors


Euronext gathers the largest and most diversified peer
group in European Biotechnology and innovative medical
devices. Biotechnology companies listed on our markets
are specialised in oncology, neurology, cardiovascular
diseases, allergies, inflammatory diseases …

Discover our initiatives designed to help Tech compa-


nies reach the next step of their growth
Renowned actors for biotechnology
euronext

€2.2bn €1.3bn €258m €214m


raised raised raised raised

A strong aftermarket with high liquidity


TechShare
Money raised by biotech companies through secondary TechShare is a free educational programme dedicated
equity deals* (€m) 2,280 to Tech entrepreneurs across Europe. The programme
supports top executives from fast-growing companies
through a combination of academic seminars, workshop
1,065 1,036 sessions, and individual coaching over 8 months. Tech-
768
539 Share is a unique networking enabler, with a Tech net-
work of 80 partners from the financial industry.

2015 2016 2017 2018 2019 Equity Research


Through a unique partnership with Morningstar ®, Euro-
Number of biotech deals next provides all listed Tech SMEs with relevant financial
32 analysis on the stock exchange.
23 22 23
18
European Rising Tech Label and Tech40 Index
The European Rising Tech label recognises the highest
2015 2016 2017 2018 2019 performing Tech SMEs listed on Euronext markets. The
* Only private placement and public offer. All data as of December 30th, 2019
top 40 companies included in the Label are also part of
the Tech 40 index, which provides additional visibility
and corporate access.

Euronext historical presence Trade & Leverage: Increasing investor access for Tech
Euronext recent expansion companies
Trade & Leverage offers a set of tools to newly listed
7 Regulated markets companies* to increase their visibility towards investors
2 Technology centres and boost their stock’s liquidity.

A European Tech Community


With 418 listed Tech companies representing a total mar-
ket capitalisation close to €462 billion, Euronext is the
primary venue for innovative companies in Europe. Since
2015, €26 billion has been raised in equity by Tech com-
panies, including 110 IPOs and multiple secondary offer-
ings. Our strong Tech franchise includes companies from
Life Sciences (Biotech & Medtech), TMT, and Cleantech.

Contact us
Euronext’s team of listing specialists is happy to answer
any questions regarding our European equity capital
markets: www.euronext.com/listings/contact-us
Download your IPO guide at www.euronext.com/ipo-guide

*Eligible companies must be located outside of France, Belgium, The Netherlands,


Portugal, Ireland and Norway © 2020 Euronext N.V. – All rights reserved.

10th european biotechnology guide 2020 78 | 79


Name · Evotec SE Evotec is a globally operating drug discovery alliance
and development partnership company headquartered
Address/P.O. Box · Manfred Eigen Campus in Hamburg, Germany. The publicly listed stock corpo-
Postal Code/City · Essener Bogen 7 ration provides comprehensive one-stop drug discov-
22419 Hamburg ery solutions with a large pool of highly experienced
Country · Germany scientists, state-of-the-art technology platforms, and
Contact Person · Gabriele Hansen first-class scientific operations. The company has key
(SVP, Corporate Communications, therapeutic expertise in the areas of neuronal diseases,
Marketing & Investor Relations) diabetes (including complications), pain and inflamma-
Telephone · +49-40-56081-255 tion, oncology, infectious diseases, respiratory diseases,
Fax · +49-40-56081-222 and fibrosis.
Email Address · info@evotec.com
Internet Website · www.evotec.com Evotec aims to identify and develop first-in-class and
Social Media · L I best-in-class differentiated therapeutics for collaborators
Number of Employees · >3,000 or for its own pipeline development. With sites in France,
Founded (year) · 1993 Germany, Italy, the UK, and the USA, Evotec drives re-
Type of Laboratory · Chemical, biological, cell culture S1, S2 search and development projects in numerous alliances
Areas of Activity · Partnered drug discovery and and partnerships with pharma and biotech companies as
development solutions as well as well as academia and foundations. Its strategy follows a
proprietary R&D on a multimodality clear goal: to become the leading drug discovery solutions
platform offering a unique set of provider by building a partnered product pipeline based
technologies and services comprising on both scientific and operational excellence.
iPSC, CRISPR/Cas9, PanOmics,
artificial intelligence, integrated Evotec has set out to contribute innovation efficiency to
biologics design, CMC, compound the drug discovery and development process. Building
management, IND-enabling studies on its expertise in the field of drug discovery services,
(INDiGO) Evotec has evolved into a drug discovery engine in its
Annual Turnover · €375.4m (2018) own right with its two business segments; EVT Execute
Relevant R&D Budget · €35.6m (2018) and EVT Innovate. Both segments operate from Evotec’s
Biological Patents · A broad portfolio of patent families unique drug discovery and development platform, which
relating to compounds, targets, and aims to achieve multimodality by providing the right set
assays. of technologies and services for any given discovery or
External · Evotec is working with more than 700 development project.
Collaborations pharma and biotech companies, not-
for-profit organisations, academia, and
foundations on a global basis. EVT Execute –
Request for · Our team of business development speed, expertise, and new technologies
Further Collaborations managers are happy to discuss our Evotec’s drug discovery platform and development ser-
R&D solutions, in- and out-licensing vices deliver an industrialised, cutting-edge, comprehen-
opportunities, and how we can assist sive, and unbiased infrastructure to meet the industry’s
you in meeting your drug discovery needs for innovation in drug discovery and accelerated
and development needs. population of its drug development pipelines. The EVT
For more information, please contact Execute segment provides stand-alone or integrated
us at info@evotec.com. drug discovery and development solutions on a typical
evotec

fee-for-service basis or through a variety of commercial


structures including research fees, milestones, and/or
royalties. EVT Execute contributes efficiency, project
management, and speed to the drug discovery and de-
velopment process. The company continuously upgrades
its platforms and has recently extended its offerings with
technologies for molecule, process, and manufacturing
design for biologics to make multimodality a reality.

EVT Innovate –
source of new pipeline entries
The EVT Innovate segment focuses on building a long-
term co-owned pharmaceutical pipeline. Evotec’s pro-
grammes focus on first-in-class and best-in-class projects
based on innovative biology or chemistry. Through its
EVT Innovate segment, Evotec builds BRIDGEs with
academia as LAB282 (Oxford, UK), LAB150 (Toronto,
Canada), LAB591 (Seattle, USA), LAB031 (Toulouse,
France), and LAB555 (Jerusalem, Israel) , which identify
and translate promising projects out of academia through
access to Evotec’s industrial-scale discovery platforms
and expertise. Evotec expands its EVT Innovate segment
through equity participation in selected companies.

Paradigm shift in drug discovery


To continue operating at the forefront of drug discovery
and development, and to be prepared to deliver pre-
cision medicine, Evotec invests in technologies with
game-changing potential, such as induced pluripotent
stem cells (iPSCs), PanOmics data, as well as artificial
intelligence and machine learning. The company aims
to facilitate the industry’s transformation to a shared
economy by providing a comprehensive, easily accessible
platform across all modalities, small molecules as well
as biologics, which meets the needs of the most ambi-
tious discovery and development goals and increases
innovation efficiency.

10th european biotechnology guide 2020 80 | 81


Name · FGK Clinical Research GmbH Company overview
FGK Clinical Research is a Europe-based CRO of an
Address/P.O. Box ·
Heimeranstr. 35 ideal size for cooperation with smaller and mid-sized
Postal Code/City ·
80339 Munich biotech, pharmaceutical, or medical device compa-
Country ·
Germany nies. FGK was founded in 2002 and currently has 140
Contact Persons ·
Martin Krauss, Dr Edgar Fenzl employees – most of them located in our headquarters
Telephone ·
+49-89-893-119-0 in Munich, Germany. Covering all phases and areas
Email Addresses ·
martin.krauss@fgk-cro.com of clinical development, our focus is on phase II and
edgar.fenzl@fgk-cro.com III trials. We have experience in all important medical
Internet Websites · www.fgk-cro.com indications, including in particular in oncology, cardiol-
www.fgk-pv.com ogy, neurology, dermatology, and gastroenterology.
www.fgk-rs.com Broad knowledge in alternative therapies completes our
Number of Employees · 140 expertise. Besides our services for drug development,
Founded (year) · 2002 we also help to guide all kinds of innovative medical
devices through the increasingly demanding framework
Areas of Activity · Full service CRO (contract research of clinical investigations.
organisation) offering a complete
range of clinical development and Locations
consulting services: We directly supervise international projects and operate
l Regulatory Affairs Europe-wide, with staff located in our headquarters in
l Project Management and Monitoring Munich, Germany and in our subsidiaries in Berlin, the
l Medical Safety Czech Republic, Hungary, and Poland. Our in-house
l Data Management / Biostatistics CRAs monitor many European study sites themselves.
l Medical Writing For additional countries and sites in the US/Canada, we
l eSolutions for Clinical Trials have suitable long-term partners.
l Quality Assurance
Our approach to a project
FGK Clinical Research has two The main philosophy for FGK is to prepare and conduct
daughter companies: studies in close cooperation with the sponsor. Thus, we
“FGK Pharmacovigilance” and not only closely interact with our clients throughout the
“FGK Representative Service”, project but long beyond it, as maintaining a good rela-
enabling us to offer our clients tionship forms the basis for long-term cooperation. FGK
pharmacovigilance services including is a full-service CRO and can conduct a study from the
services of QPPV and PMSF planning to the final report and beyond. Our operational
management as well as legal team works hand in hand with all other departments
representation for non-European involved. Distances for internal information flows are
customers conducting clinical studies very short since most staff is in-house and located in
or seeking marketing authorisation the Munich HQ. This also applies for the project man-
within the EU/EEA. ager, who is the central contact person delivering all
required information to the sponsor. Timely approvals
and efficient trouble-shooting are achieved through a
combination of centralised project management and
local monitoring, as well as local expertise in regulatory
submissions within the country of study conduct.
fgk clinical research

Services
Consulting
·· Advice for drug and device development
·· Biostatistical support

Regulatory Affairs
·· Submission
·· All communication with competent authorities and
ethics committees

Project Management and Monitoring


·· Development of study documents
·· Study set-up and feasibility
·· Investigator meetings
·· Site management & monitoring
·· TMF handling

Medical Safety
·· Adverse Event Management and assessment/reporting
·· Drug Safety, medical monitoring and adverse event
coding

Data Management / Biostatistics


·· CRF design
·· Data collection, review, and analysis

Medical Writing
·· Generation and review of entire spectrum of
regulatory documents

eSolutions for Clinical Trials


·· eCRF with integrated IWRS, eTMF

Quality Assurance
·· Regularly reviewed and updated set of SOPs
·· Quality system audited on a regular basis
·· Audits on behalf of sponsors
·· Assistance during inspections

Since 2017, we have been participating in an independent


“GCP Qualification Programme”, offering our clients the
possibility to obtain an all-encompassing audit report
from a third party. Visit our website www.fgk-cro.com to
learn details about our complete portfolio.

10th european biotechnology guide 2020 82 | 83


Name · FILTROX Group Company profile
As the global leader in depth filtration, FILTROX offers
Address/P.O. Box · Moosmühlestr. 6 complete solutions and systems for the filtration of
Postal Code/City · 9000 St. Gallen valuable liquids. We are experts in the development
Country · Switzerland and manufacturing of Swiss quality products for a wide
Contact Person · Ralph Daumke range of applications in the pharmaceutical, biotechnol-
Telephone · +41-71-272-9236 ogy, chemical, and cosmetics industries. Since 1938,
Fax · +41-71-272-9100 filter media and filter systems have been developed and
Email Address · r.daumke@filtrox.ch produced at our corporate headquarters in St. Gallen.
Internet Website · www.filtrox.com Based on this experience, we offer a wide range of
Social Media · I products and customised solutions.
Number of Employees · 300 It is our pleasure to share our expertise in the area of
Founded (year) · 1938 application and filtration technology, to optimise your
processes. We offer filtration training, seminars, audits,
Areas of Activity · l Microfiltration and treatment of and training tailored to customer requirements.
high-value liquids The FILTROX Group has a worldwide distribution net-
l Depth filtration work, which provides comprehensive technical support.
l Single-use cell removal Our well-trained sales teams provide you with on-site
l Activated carbon filter assistance and ensure worldwide rapid product avail-
ability. For more information, please visit our website.
External · l ZHAW Wädenswil, Switzerland
Collaborations l FH Trier, Bioverfahrenstechnik, Products
Prof. Kampeis, Germany FILTRODICS™ BIO SD
lH  ES-SO, Institute of Life Technologies, FILTRODISC™ BIO SD is the first depth filter using the
Prof. Kalman, Switzerland advantages of the well-established method of alluvial
(cake or precoat) filtration technology in a disposable
Request for · Partners for business and product format. FILTRODISC™ BIO SD is used e.g. for single-
Further Collaborations development use cell removal, as the system is fully scalable and
disposable, fulfilling all validation requirements.

Depth filter sheets and lenticular filter modules:


PURAFIX® depth filter sheets have been specifically
developed for use in critical applications in the pharma-
ceutical or biological industries. They are characterised
by their extremely low levels of ions and pyrogens.

PURAFIX® PF-P filter sheets are reinforced with plastic


fibers and typically used when a very high wet strength
or stability is required. The new PURAFIX® PF-P has
been developed specifically for the high requirements
of the life sciences industry. With its very high stability,
easy handling, and efficient filtration properties it is
ideal for precoating or cake filtrations, e.g. in the plasma
fractionation industry.
filtrox

CARBOFIL™ sheets allow the user to handle immobi-


lised activated carbon in a much cleaner way than with
loose carbon powders. It offers significant potential for
API manufacturers around the world to optimise their
process.

Plate and frame filters and module housings:


NOVOX® systems are high precision stainless steel
CARBOFILTM plate and frame filters for heavy-duty use. The NOVOX®
CP filter is designed and built for pharmaceutical and
other critical applications. The plates are available in
BIO SD SKID stainless steel, polypropylene, or PVDF (other materials
on request). The NOVOX® CP is an enclosed filtration
system completely sealed for CIP without filter sheets.
This eliminates any drip loss and prevents the liquid from
NOVOX® CPPI having contact with the outside environment.

DISCSTAR™ is a highly precise stainless steel filter


housing for lenticular filter modules for everyday use.
With the DISCSTAR™ H, we have developed the new-
est generation of lenticular module housing, which is
much safer to operate and easier to handle due to its
horizontal working position. The enclosed system al-
lows depth filtration to be carried out without drip loss.
The DISCSTAR™ P with its tri-clamp connections and
pharma-approved valves and pressure gauges is the
ideal housing for highly sensitive applications in life
sciences, pharmaceutical and biotech applications
(biomass removal), APIs, and injectables.

Locations
DISCSTARTM H FILTROX AG Switzerland
All depth filter sheets and modules for pharmaceutical
applications manufactured here.
FILTROX France s.a.r.l., Sales office
FILTROX North America USA, Sales office
FILTROX Latinoamerica S.A. de C.V., Mexico, Sales office
FILTROX (Shanghai) Filtration System Co., Ltd. China,
Sales office
FILTROX UK & Northern Europe UK, Sales office
FILTROX Southern Europe Spain, Sales office
FILTROX Asia-Pacific Pte Ltd. Singapore, Sales office

10th european biotechnology guide 2020 84 | 85


Name · Fördergesellschaft IZB – Hotspots for life science start-ups
Innovations- und Gründerzentrum The IZB, founded in 1995, is the operating company for
Biotechnologie mbH the Innovation- and Start-up Centers for Biotechnology
located in Planegg-Martinsried and Freising-Weihen-
Address/P.O. Box · Am Klopferspitz 19 stephan, and has developed into one of the top ten bio-
Postal Code/City · 82152 Planegg/Martinsried technology centers in the world. Currently, in an area
Country · Germany totaling 26,000 m2, over 50 biotech companies with over
Contact Person · Dr Peter Hanns Zobel 600 employees are located. An essential criterion for the
Telephone · +49-89-5527948-0 success of the IZB is its close proximity to outstanding
Fax · +49-89-5527948-29 research at the Ludwig-Maximilians-University (LMU)
Email · info@izb-online.de and renowned biotechnology research establishments
Website · www.izb-online.de on the Campus Martinsried, such as the Max-Planck-
Number of Employees · 36 Institutes für Biochemistry and Neurobiology.
Founded (year) · 1995
Type of Laboratory · S2 labs Magnet for biotech start-ups
Areas of Activity · | Biotechnology Since 1995, the Planegg-Martinsried location, now
| Life Sciences covering 23,000 m2, has accommodated Start-ups fo-
cusing on medical biotechnology. Since 2002, the IZB
Number of Firms · over 50 start ups in Freising-Weihenstephan with 3,000 m2 of space offers
optimal conditions for establishing companies in the
External · Collaborations with the scientific sector of life sciences.
Collaborations faculties on the Campus Martinsried Here, young entrepreneurs and company founders come
upon an optimal infrastructure for transforming their
products or services into business propositions, within a
competence cluster for life sciences that is one of the best
in the world. S1 labs for fair rental prices, internal prop-
erty management, close contact to the venture capital
scene, as well as joint location marketing are also factors
for our success, as is the flexibility to adapt space require-
ments to the development of our tenants.

Top research at
the Campus Martinsried
Today the scientific and business Campus Martinsried
is one of the largest centres in Europe where teaching,
basic scientific and clinical research, as well as technol-
ogy innovation are combined on one campus. Located
in the direct vicinity are other institutes such as the Max-
Planck-Institutes for Biochemistry and Neurobiology, the
Helmholtz Zentrum Munich Hematology Unit and the
following institutes of the LMU: the Biology Faculty, the
Clinical Center Grosshadern, the Pharmacy and Chem-
istry Faculty, the Neurological Research Center, the
Center for Neuropathology and Prion Research (ZNP),
IZB

the Gene Center and Institute for Biochemistry, the Bio-


medical Center, the BioSysM Bavarian Research Network
for Molecular Biosystems and the Surgery Center of the
Clinical Center Grosshadern.

The close proximity of the scientific institutes around the


Campus Martinsried confers a huge competitive advan-
tage. Young scientists can profit from incorporating ex-
pertise in science and research into their own business
enterprises; short distances promote interaction and
cooperation between biotech companies – in terms of
globalisation both factors are essential requirements for
successfully entering world markets.

IZB Residence and Faculty Club G2B


The 28-meter high IZB Residence CAMPUS AT HOME
that opened in October 2014 is the architectural and
communicative centre point of the Campus Martinsried.
The sevenstorey building with 42 rooms and its own
restaurant will accommodate visiting scientists from all
over the world. The core element is the Faculty Club G2B.
Its purpose is to promote the transfer of research results
into marketable products and services, and intensify the
dialogue between top class scientists.

IZB – in brief
·· 2 6,000 m2 laboratory and office space for start-ups
and growing companies
·· Home for more than 50 start-ups
·· Business development support
·· In-house estate management
·· Center of an impressive research campus
·· Access to an international network
·· Flexible lab and office structures
·· Close contacts with investment partners
·· Joint location marketing
·· Attractive, modern conference rooms, also for exter-
nal booking
·· IZB Residence CAMPUS AT HOME (42 Rooms)
·· Faculty Club G2B
·· Restaurants: SEVEN AND MORE and
Café Freshmaker
·· 2 day care centres (Bio Kids & Bio Kids2)

10th european biotechnology guide 2020 86 | 87


Name · Fraunhofer Institute for Toxicology and Company overview
Experimental Medicine ITEM, As a service to clients, Fraunhofer ITEM develops bio-
Division of Pharmaceutical pharmaceutical manufacturing processes, performs
Biotechnology investigations into cause-and-effect processes, devel-
ops methods and concepts for disease diagnosis and
Address/P.O. Box ·
Inhoffenstr. 7 therapy, and conducts preclinical and clinical studies.
Postal Code/City ·
38124 Braunschweig All studies with drug regulatory status are performed in
Country ·
Germany compliance with current GXP regulations: preclinical
Contact Person ·
Prof. Dr Holger Ziehr development is performed in compliance with GLP,
Telephone ·
+49-531-6181-6000 clinical studies are conducted in compliance with GCP
Fax ·
+49-531-6181-6099 and biopharmaceutical active ingredients (APIs) and
Email ·
biopharmaceutical-services@item. final dosage forms are manufactured in compliance with
fraunhofer.de GMP requirements.
Number of Employees · Institute: 357
Pharmaceutical Biotechnology: 54
Founded (year) · 1981 Division of
Type of Laboratory · S1, S2, clean rooms of grades pharmaceutical biotechnology
D, C, and B The service portfolio of the Fraunhofer ITEM Division of
Pharmaceutical Biotechnology covers the development
Areas of Activity · Biopharmaceutical consultancy, cell of manufacturing processes for biopharmaceutical APIs
line development, GMP-contract such as proteins, antibodies and nucleic acids, as well
manufacture of cell banks and as manufacture of technical batches for preclinical
investigational biopharmaceuticals, research. Additionally, the division transforms API
bioprocess development, analytical manufacturing processes to comply with current Good
development and bioanalytical service, Manufacturing Practice (GMP) requirements. For its
aseptic fill and finish of investigational pharmaceutical clients the division performs manufacture
medicinal products of APIs and sterile investigational medicinal products
(IMPs) for use in early-phase clinical trials.
Annual Turnover · €28.9 million (2018)
The division’s GMP facilities have been licensed since
Request for · l C ollaborations concerning GMP 1997. They are equipped with stirred-tank bioreactors
Further Collaborations manufacture for clinical trials and of up to 400 litres volume, with process scale chroma-
analytical development tography systems and process filtration systems, ena-
l Manufacture of investigational bling GMP-compliant manufacture of investigational
medicinal products biopharmaceutical APIs in gramme quantities. Process
equipment is located in grade-D, grade-C, and grade-B
clean rooms that have been EU-licensed by the regula-
tory agencies but meet US regulatory standards (FDA)
as well.
Fraunhofer ITEM

Core elements of the GMP clean-room facilities are


clean-room grade-B (class-1000) suites housing laminar
flow hoods that represent class-100 work environments
(clean-room grade A) for manual aseptic fill and finish
operations or as restricted-access barrier system (RABS)
equipped with an automatic filling machine for vials and
ampoules of volumes between 1 and 20 millilitres.

Services
·· D evelopment of cell lines based on insect cells, mam-
malian cells (e.g. CHO), and microorganisms (e.g.
E. coli) for manufacture of biopharmaceutical APIs
·· GMP manufacture of master and working cell banks
·· N2 gas-phase storage and shipment of cell banks
·· D evelopment of manufacturing processes for bio-
pharmaceutical active ingredients based on proteins,
glycoproteins/antibodies, nucleic acids/plasmids,
virus-like particles, and bacteriophages
·· Validation of cultivation (USP) and purification (DSP)
unit operations and processes
·· D evelopment and validation (Q2) of bioanalytical
methods
·· ICH compliant stability testing of drug substances
and IMPs
·· N on-GMP and GMP contract manufacture of bio-
pharmaceutical active ingredients
·· Aseptic manufacture of final dosage forms as IMPs
for clinical trials
·· GCP
 labelling and QP release of IMPs for clinical trials

10th european biotechnology guide 2020 88 | 89


Name · Fundación MEDINA Fundación MEDINA is a non-profit public-private part-
nership between Merck Sharp & Dohme de España
Address/P.O. Box · Avda Conocimiento 34, S.A., the Regional Government of Andalucía, and the
Health Sciences Technology Park University of Granada to discover innovative com-
Postal Code/City · 18016 Granada pounds and therapies for unmet medical needs.
Country · Spain MEDINA was established in 2008 in the Health Sci-
Contact Person · Dr Olga Genilloud ences Technology Park in Granada from the former
Telephone · +34-958-993-965 Basic Research Centre of MSD de España (CI BE-MSD)
Fax · +34-958-846-710 in Spain, one of the longest operating and most suc-
Email · olga.genilloud@medinaandalucia.es cessful natural products (NPs) drug discovery pro-
Website · www.medinadiscovery.com grammes in the pharmaceutical industry.
Social Media · FL I  Leveraging this industrial-derived experience, highly
Number of Employees · 40 qualified research team, and cutting-edge technology
Founded (year) · 2008 platforms, MEDINA is a Centre of Excellence for re-
Type of Laboratory · Non-profit research organisation search and development in drug discovery and high-
Areas of Activity · l Natural Products Discovery: pharma- value biotechnology products. MEDINA scientists have
ceutical, agrochemical, biotechnology been attracted from the pharmaceutical, biotech, and
and cosmetics applications academic sectors, and they operate as part of a multi-
l Natural Products Microbiology: micro- disciplinary team with skills in molecular and cell bio-
bial diversity, fermentation and secon- logy, industrial and clinical microbiology, informatics
dary metabolism, genome mining, and and automation, compound management, analytics,
metagenomics and NPs chemistry.
l Natural Products Chemistry: isolation
and structural elucidation, analytical “Natural products are pivotal in inspiring chemists and
profiling providing innovative chemistry for novel therapeutic
l ADME and Bioanalytics: pharmacoki- agents.”
netics, early safety, toxicology meta- MEDINA is an internationally recognised leader in drug
bolomics, and biomarkers discovery from microbial natural products. We make
available for discovery of new NPs one of the world’s
External · Pharma and biotechnology companies most productive and diverse collections (190,000
Collaborations in human health, agri-food, and strains) and libraries (200,000 samples) that can be
cosmetics; academic centres, explored for mining new genes and unique enzymes
universities, and hospitals; EU consortia with broad biotechnological applications.
and PPPs MEDINA focuses its discovery programmes on novel
drugs for infectious and parasitic diseases, oncology
Request for · New collaborations/business opportu- and immunomodulation, and neurodegeneration. We
Further Collaborations nities in the discovery of novel drug have extensive experience in high throughput screening
leads and enzymes with applications in (HTS) with libraries of microbial NP extracts and syn-
pharma and other industrial sectors thetic compounds in a large diversity of assay formats,
(crop protection, agri-food, and cos- and we develop collaborative research in all these areas
metics). New partners in synthetic biol- with competitive funding from national and European
ogy with genome mining interests to programmes.
explore MEDINA’s microbial collections.

Member of European
Biotechnology
NET WORK
fundación MEDINA

MEDINA is developing unique NP library modules in


source diversity and chemical space, to be used in drug
discovery. Based upon our record of identifying drug-
like compounds from microorganisms, we offer oppor-
tunities to discover neglected and novel scaffolds un-
known in synthetic libraries. We offer to our partners in
the scientific community and the pharmaceutical, bio-
technology, cosmetics, and agrochemical sectors ac-
cess to a unique platform for NPs discovery derived
from a superbly diverse microbiological arsenal.

MEDINA is developing collaborative drug discovery


research programmes with international academic insti-
tutions, biotechs, and Big Pharma. MEDINA is actively
seeking to establish collaborative agreements that
could bring lead candidates into the preclinical stage:
“Our public-private model offers a privileged position
to establish successful partnering relationships with
research groups in the academic and biopharmaceuti-
cal sectors.”

MEDINA provides contract research services including


access to its libraries and the NP drug discovery plat-
form with expertise in HTS and structural elucidation of
complex small molecules, and a high throughput pre-
clinical ADME/safety platform for the evaluation of
potential cardiovascular liabilities and adverse drug
metabolism effects and PKPD of early development
drug candidates.

MEDINA bioanalytical and metabolomic platforms


perform both discovery and new biomarkers identifica-
tion studies in collaboration with international research
communities. The LC-MS platform allows high through-
put analysis of liquid and tissue biopsies from clinical
and animal model samples, as well as plant and micro-
bial extracts. Statistical analysis and predictive models
are applied for patient stratification and to identify meta-
bolic pathways involved in key biological processes.

10th european biotechnology guide 2020 90 | 91


Name · GenScript Biotech Corporation GenScript Biotech –
the leader in synthetic biology
Address/P.O. Box · BioPartner 4, Robert Boyleweg 4
Postal Code/City · 2333CG Leiden The advent of synthetic biology
Country · The Netherlands Ever since Dr Har Gobind Khorana first synthesised a
Contact Person · Jungsoo.Park@genscript.com stretch of poly(UC) and discovered the codons to win the
Telephone · +31-715690120 Nobel prize in 1968, synthetic biology has undergone
Email Address · info@genscript.com considerable growth in scope, expectation, and output,
Internet Website · www.genscript.com and has become a widely recognised branch of biological
Social Media · FI research without which we cannot talk about any modern
Number of Employees · 3,350 biotechnology. GenScript Biotech (GenScript) is the lead-
Founded (year) · 2002 ing company in synthetic biology with the largest market
Type of Laboratory · GMP share in the world. Founded in 2002, it is one of the first
companies to provide research-grade oligonucleotides
Areas of Activity · l Molecular biology and synthetic genes that can reach up to 200Kb in length.
l Protein engineering According to a recent market report, GenScript has a
l Gene editing market share of 30% of synthetic biology in the world.
l CDMO
The first COVID-19 full-length genome synthesis
Soon after the outbreak of COVID-19 in 2019, its full ge-
nome sequence was revealed by many groups worldwide.
GenScript started working on the synthesis of the artificial
genome of the virus in response to the request from the
Institute of Virology and Immunology in Switzerland. In a
couple of weeks, GenScript successfully completed the
synthesis of the 20Kb genome of the virus. It was cloned
into a yeast artificial chromosomes (YAC) by the Swiss
group, and it became the very first clone of COVID-19 in
the world, which is ready for another research such as
therapeutics and vaccine development. Among many
other companies who tried to synthesise, GenScript was
the first and the only company who successfully com-
pleted the synthesis of the whole genome of COVID-19. It
was possible thanks to the deep know-how accumulated
over decades of experiences of GenScript.

GenScript at the moment


Based on its strong foundation on synthetic biology, it suc-
cessfully expanded its business areas to diverse life science
sectors including cell biology, protein engineering, enzyme
optimisation using random mutation or rational design,
antibody development and production, immune and cell
therapies, gene editing (CRISPR-Cas9) and bioinformatics.
It currently retains more than 70 patents and over 200 patent
genscript

applications. In 2016, the company went public in the Hong-


Kong stock market (1548.HK) and raised 67M USD during
its IPO. GenScript currently has more than 3,000 employees
globally, and it has a number of leading commercial tech-
nologies developed in the fields of synthetic biology, As of
January 2019, GenScript’s products and services have been
cited by 36,500 scientific papers worldwide.

GenScript ProBio – a CDMO unit


GenScript ProBio is the bio-pharmaceutical Contract
Development and Manufacturing Organization (CDMO)
Har Gobind Khorana was the first scientist to chemically synthesize oligonucleotides. By segment of GenScript. The name of “ProBio” indicates 3
synthesizing poly(UC) RNA and in invtro translation he discovered that UCU and CUC codes
serine and leucine. This achievement, in the 1970s, was also the world’s first synthetic gene; core philosophies – being PROACTIVE, PROFESSIONAL
in later years, the process has become widespread. Subsequent scientists referred to his and PROCESS-oriented. GenScript ProBio shows its
research while advancing genome editing with the CRISPR/Cas9 system.
dedication to proactively provide end to end service (dis-
covery to commercialisation) with professional solutions,
and controllable quality process to accelerate drug devel-
opment for customers.

Key facts and figures


·· Estimated market share in gene synthesis: 30.54%
(QYResearch 2019)
·· The number of publications cited: 36,500 (Jan 2019)
·· The average number of new publications cited per
day: 5.8 articles per day (Feb 2020)
·· The total number of employees: 3350
·· Percent of employees with a higher degree: 28%
·· Gene synthesis capacity: over 100M bp per month
Rooted in strong foundation of synthetic biology, GenScript successfully expanded its business
area to biologics development and production. ·· Record-long gene synthesis: 200Kbases
·· Locations: Piscataway, NJ, USA / Leiden, the Neth-
erlands / Nanjing and Zhenjiang, China

Key business area


·· Gene synthesis
·· Peptide synthesis
·· Protein expression, purification, and modification
·· Antibody development and production
·· Gene editing (CRISPR-Cas9)
·· CDMO (Contract Development and Manufacturing
Organization)

References
GenScript’s US headquarter in New Jersey, US
https://doi.org/10.1021/ja00906a021
https://doi.org/10.1101/2020.02.21.959817

10th european biotechnology guide 2020 92 | 93


Name · GETEC PARK.SWISS AG GETEC PARK.SWISS AG offers real estate and services
for the chemical and life sciences industries. The site is
Address/P.O. Box · Rothausstrasse 61 ideally located close to Basel in the centre of Europe. To
Postal Code/City · 4132 Muttenz date 30 companies either active in the field of the R&D
Country · Switzerland and production of specialty chemicals as well as phar-
Contact Person · Dr Peter von Natzmer maceuticals or providing special services to this industry
Telephone · +41-61-264 02 84 are based at GETEC PARK.SWISS.
Email Address · sales@getec-park.swiss
Internet Website · www.getec-park.swiss Basel region: one of the world’s leading
Number of Employees · 330 destinations in life sciences
Founded (year) · 2011 Basel is one of the most dynamic economic regions in
the world. In the Basel area you will find an enormous
Areas of Activity · Chemical & Life Sciences Park concentration of innovative companies involved in life
sciences and many research groups from renowned
research institutes worldwide, an open-minded culture,
an international environment, business-friendly condi-
tions, and a quality of life that will fulfil the most stringent
requirements.

Excellent network of life sciences and


biotech industries & research institutes
Thanks to the network of GETEC PARK.SWISS, com-
panies located in our park can tap into an unrivalled life
sciences/biotech talent pool. The Basel area is home to
world-famous life sciences and chemical companies,
making the Basel region one of the most successful life
sciences locations in the world. More and more com-
panies are developing not only chemical but also bio-
logical processes for the manufacturing of active ingre-
dients. This includes the big global companies in the
Basel region, namely Novartis, Roche, BASF, Bayer, and
Syngenta, but also companies like Actelion, Basilea,
Idorsia, and Bachem, as well as promising biotech start-
up companies.

Real estate offers of GETEC PARK.SWISS


GETEC PARK provides the chemical and life sciences
industry with 50 hectares of outstanding developed real
estate. Besides existing buildings, which can be con-
verted to meet actual demand, around 14 hectares of
free plots are available to interested companies.
getec park.swiss

Custom-tailored services
To allow customers of GETEC PARK to concentrate on
their core business activities, we offer the benefits of a
comprehensive range of services:
·· Facility Management
·· Utilities (energy products and resources)
·· Waste Disposal (incineration of solid, liquid as well as
gaseous waste including source exhaust air, unique
wastewater pretreatment)
·· Solvent recovery
·· Health, Safety, and Environment: experts provide
solutions-led advice to our customers for their indi-
vidual projects as well as support the completion of
the groundwork and documents required to ensure
the viability of their investment planning for submis-
sion to the authorities
·· Analytics (with ISO 17025 accreditation)
·· Logistics (storage & handling of hazardous & danger-
ous goods)
·· Technical Services (engineering, repair, and mainte-
nance)

Our Services Speed


According to our customers, one of the decisive factors in
> Facility Management locating their enterprise at GETEC PARK in Muttenz is the
speed with which they can realise their business, be it the
> Utilities permit to start with the construction work of a production
building or the permit to start manufacturing chemical
> Waste2Energy
products. Compared to other European locations the au-
> Waste2Value: Solvent Regeneration thorities show a professional approach in dealing with
special requests and are very familiar with the processes
> Wastewater Handling incl. Pretreatment in the chemical and pharmaceutical industries.

> Analytical Services


GETEC PARK.SWISS: home to the chemical,
> Logistics pharmaceutical, and biotech industries
GETEC PARK offers all the advantages of a chemical
> Health, Safety, Security and Environment and life sciences park: services from a single source that
allow our customers to focus on their core compe-
> Engineering
tences. And our location is ideal: hardly any other region
> Maintenance in the world demonstrates a comparable concentration
of companies and research institutions in this fields. The
chemical, life sciences, and biotech industries are at
home here – at GETEC PARK.SWISS.

10th european biotechnology guide 2020 94 | 95


Name · glyXera GmbH glyXera GmbH is a Max Planck Society spin-off, specialised
in high performance glycoanalysis.
Address/P.O. Box · Brenneckestraße 20 – ZENIT We are utilising separation and mass spectrometry based
Postal Code/City · 39120 Magdeburg glycoanalytical tools and have substantial experience in
Country · Germany providing glycoanalytical products & services tailored to
Contact Person · Dr Erdmann Rapp (CEO & CSO) the specific needs of our customers.
Telephone · +49-391-6117-251 Worldwide exclusively glyXera provides the high-
Fax · +49-391-6117-255 performance glycoanalysis system glyXboxTM.
Email · info@glyxera.com
Website · www.glyxera.com Our clients include leading pharmaceutical, biotechnology
Founded (year) · 2011 and food companies throughout the world. We offer you
Type of Laboratory · | Glycomics our sophisticated technology platforms and our expertise
| Glycoproteomics with respect to glycoanalytical services, tailored to your
| Proteomics specific needs. We guide you for better decisions and help
you to perform better and faster during discovery phase,
Areas of Activity · High Performance Glycoanalytical & R&D, (clinical) trials and approval of your innovative
(Glyco)Proteinanalytical Services & products (biopharmaceuticals, vaccines, food additives,
Products functional food, etc.), and QA/QC in your production stages.

Expertise & pace


glyXera GmbH is specialised in glycoanalysis, utilising
state-of-the-art separation and mass spectrometry-
based glycoanalytical tools and has a strong back-
ground in providing glycoanalytical services. We run
modern analytical and synthesis labs, equipped with
state-of-the-art instrumentation.

glyXera offers high performance glycoanalysis to its


clients, providing sophisticated technology platforms and
expertise with respect to glycoanalytical services, tailored
to the specific needs of the variety of its customers from
academia, clinics, pharmaceutical and food industries.
We have substantial experience in glycomics, glycopro-
teomics and proteomics of biotechnological (e.g. recom-
binant glycoproteins (mAbs, fusion proteins, factors,
hormones, etc) or viral membrane glycoproteins) and
clinical (blood, milk and and other body fluids) samples.

High-performance glycoanalysis
glyXera provides exclusively worldwide fast and reliable
glycoanalysis utilising a “real” high-throughput system
(method/software/database) with superior performance
and capacity compared to other glycoanalysis tools
available on the market.
Glyxera

Our patented system glyXboxTM, based on multiplexed


capillary gelelectrophoresis with laser induced fluores-
cence detection (xCGE-LIF) enables generation and
comparison of glyco-fingerprints from large sets of
samples and structural analysis of glycans within these
samples.

High throughput, high resolution, high sensitivity, high


reproducibility, high reliability:
·· Up to 96 capillaries in parallel enable “real” high
throughput
·· Up to 3500x more sensitive and 450x faster, com-
pared to LC
·· An order of magnitude higher separation power,
compared to LC

High-performance glycoanalysis on 3 levels:


·· Glycofingerprinting: Glycosylationpattern analysis &
comparison
·· Standard Glycoprofiling: Identification of glycans in
complex mixtures via database matching
·· Extended Glycoprofiling: Extended structural analysis of
glycans in complex mixtures using exoglycosidase
sequencing in combination with repeated glycoprofiling.

Our services
·· Glycofingerprinting & Glycoprofiling by xCGE-LIF &
HILIC-FLR
·· MALDI-MS based Glycoprofiling
·· LC-MS based profiling of N- and/or O-glycans
·· Monosaccharide (Composition) Analysis
·· Site Occupancy Analysis
·· Proteomics
·· N- & O-Glycopeptide Mapping
·· N- & O-Glycoproteomics
·· General (Glyco)-Protein Characterisation by Protein
Gel Electrophoresis Pattern Analysis

Our products
·· glyXboxCE: High performance glycoanalysis system
based on xCGE-LIF (incl. glyXtoolCE software)
·· glyXboxLC: Standard glycoanalysis system based on
HILIC-FLR (incl. glyXtoolLC software)
·· Tailored standards & kits for glycoanalysis

10th european biotechnology guide 2020 96 | 97


Name · Hezelburcht Hezelburcht | Grant consultancy
For 25 years Hezelburcht has provided grant support to
Address/P.O. Box · High Tech Campus 10 assist our clients in achieving their strategic, financial,
Postal Code/City · 5655 Eindhoven and innovative ambitions. In addition to providing serv-
Country · The Netherlands ice in the Netherlands, we are experienced in applying
Contact Person · Petra Dijkman, PhD. for grants at the regional, national, and European levels
Telephone · +31-6-21-99-37-52 for clients throughout Europe and beyond.
Email Address · p.dijkman@hezelburcht.com
Internet Website · www.hezelburcht.com/en/ Our headquarters in Nijmegen works closely with
Social Media · LI the offices in Brussels, The Hague, Amsterdam, and
Number of Employees ·100 Eindhoven, all of them forging strong links between
Founded (year) ·1995 numerous academic and industrial parties and (regional)
Areas of Activity ·l Grant identification funding bodies.
l Feasibility assessment
l Grant writing
l Review Life Sciences, Health & Food team
l Consortium building The Life Sciences, Health & Food team consists of
l Project management ambitious and entrepreneurial consultants with high-
External · Hezelburcht has an extensive track quality backgrounds and provides support for both
Collaborations record regarding European subsidies, fundamental scientific research and commercial R&D.
in terms of writing applications and Their scientific backgrounds range from biomedical
consortium building as well as strategic engineering, health & nutrition, oncology, biology, and
consulting, project management, and eHealth to neuroscience. Besides a solid scientific
compliance. Please visit our website for background, most of them have extensive, practical,
examples of testimonials from some of sector-specific experience.
our clients.
l Eindhoven University of Technology –
H2020 Marie Skłodowska-Curie Supporting world-class universities &
project Photo4Future innovative companies with funding
l Omnigen B.V. – Eurostars Hezelburcht has an extensive track record regarding
l MaxWell Biosystems AG – H2020 SME European subsidies, in terms of writing applications,
Instrument consortium building as well as strategic consulting,
l PROMINENT by University Medical project management, and compliance. Our knowledge
Centre of Groningen (UMCG) and the of grants as well as our experience in both the public
Faculty of Science and Engineering of and private sectors enable us to offer a full spectrum of
the University of Groningen – H2020 services related to grants and incentives. Our specialists
Marie Skłodowska-Curie COFUND have broad experience in supporting every step of the
Request for · Researchers and innovative entrepre- grant application process for European programmes
Further Collaborations neurs from both industry and such as Eurostars and the H2020 Health programme,
academia are welcome to contact us SME Instrument, and Fast Track to Innovation.
for an informal introduction to our
support for grant acquisition.
European
Member of Biotechnology
NET WORK
hezelburcht

What our customers say


Eurostars for market-oriented R&D: Omnigen B.V. fo-
cuses on both scientific research and services within the
fields of genetics and bioinformatics. Using just a little
saliva, Omnigen can analyse your DNA. Omnigen has
received funding from the European grant programme
Eurostars to initiate a clinical decision-making and sup-
port platform for pancreatic cancer, called IMedFrame.
Hezelburcht coordinated the grant application for Om-
nigen and its partners.

“We have experienced the collaboration with Hezel-


burcht as pleasant. Thanks to the scientific background
of the grant experts, we have been able to submit a high
quality project application. We recommend working with
Hezelburcht for grant advice and acquisition!”
 Omnigen B.V.

Horizon 2020 MSCA international trainings network (ITN):


The project Photo4Future focuses on photochemistry,
has received funding from the Marie Sklodowska-Curie
subsidy programme, and is coordinated by the Eind-
hoven University of Technology (TU/e). In 4 years, 10
doctoral students have developed new photochemi-
cal applications through multidisciplinary research to
provide energy-efficient and green alternatives to the
chemical industry. In order to be able to focus on the
project’s primary activities, the TU/e is outsourcing the
project management to Hezelburcht.

“Working with Hezelburcht allows the researchers to


focus on the real work, namely the research. This means
that we can work more efficiently and results-oriented.
As coordinator, I am therefore extremely pleased with
the smooth collaboration with Hezelburcht!”
 Dr Timothy Noël, TU/e.

More information?
Should you have any questions or like to receive more
information about grant opportunities for academia or
industry, please contact us.

10th european biotechnology guide 2020 98 | 99


Name · IBA GmbH IBA GmbH – Solutions for Life Sciences
For more than two decades IBA Lifesciences develops
Address/P.O. Box · Rudolf-Wissell-Str. 28 and provides innovative solutions for your life science
Postal Code/City · 37079 Göttingen applications. IBA’s portfolio includes tools for Cell
Country · Germany Selection & Expansion, Protein Production & Assays as
Contact Person · Dr Mike Rothe well as Custom Oligos & Predefined DNA/RNA.
Telephone · +49-551-50672-0
Fax · +49-551-50672-181
Email · info@iba-lifesciences.com Product portfolio
Website · www.iba-lifesciences.com Cell selection & expansion
Social media · FL I  IBA’s Fab-TACS® technology allows quick and conven-
Number of Employees · ~50 ient cell selection directly from human blood, mouse
Founded (year) · 1996 splenocytes or other samples. Strep-tagged Fab-
Type of Laboratory · S1 fragments (Fab-Streps) reversibly capture and release
the target cells during the selection process. This sys-
Areas of Activity · l Cell Selection & Expansion tem delivers label-free, non-activated target cells in a
l Protein Production & Assays standardized manner with a highly reproducible qual-
l Custom Oligos & Predefined DNA/RNA ity. Isolated cells are suitable for various downstream
applications, including cell-based diagnostics or as-
Biological Patents · l Strep-Tactin®XT says. We offer kits for manual cell selection with our
l Twin-Strep-tag® Fab-TACS® Gravity columns or for a convenient auto-
l Streptamer ® mated procedure using our FABian® device. Our port-
folio also includes surface protein- or antigen-specific
External · Numerous in- and out-licensing cell selection and staining by reversibly binding cells
Collaborations contracts to magnetic bead- or fluorochrome-labelled Fab- or
MHC I-Streptamers®. In addition, we offer CD3/CD28
Streptamers® and various peptides for T cell expansion
and stimulation. Our cell selection and expansion prod-
ucts ensure cell functionality and viability and thereby
contribute to high quality research.

Protein production & assays


The Strep-tag ® technology is IBA’s proprietary and
versatile protein purification, detection, and immobilisa-
tion platform. It is one of the most widely used systems
for affinity purification, providing exceptionally pure
proteins. The system includes two affinity tags: Strep-
tag ® II and Twin-Strep-tag ®. By exploiting the highly
specific interaction of these affinity tags for either Strep-
Tactin® or its high affinity variant Strep-Tactin®XT, Strep-
tagged proteins can be isolated in one step from crude
cell lysates in unparalleled purity. The mild purification
and elution conditions enable structural and functional
investigations, protein-protein interaction studies,
IBA

ligand-receptor investigations or even separation of


living cells for re-culturing processes. The system is
suitable for a large variety of protein classes, e.g. met-
allo proteins and membrane proteins. The near covalent
affinity of especially the Twin-Strep-tag ® to Strep-
Tactin®XT can be used to efficiently immobilise proteins
for assay development and screening. This opens new
possibilities in the pharmaceutical and biotech industry
for example for screening of new diagnostic targets and
the development of diagnostic assays.

Custom oligos & predefined DNA/RNA


IBA’s nucleic acid division focuses on specialised nu-
cleic acid custom services. The tailor-made DNA and
RNA oligonucleotides, including modified and labelled
nucleic acids, require particular care in synthesis and
are of the highest quality. Applications can be found in
e.g. real-time PCR, FRET, gene silencing studies, im-
mobilisation, FCCS, or high-resolution microscopy. The
innovative Click Chemistry enables additional dye com-
binations with unsurpassed labelling densities. More
than 200 fluorescent labels and more than 80 modifica-
tions are available. With our expertise, we can also
produce custom DNA and RNA aptamers according to
your individual specifications.

Business model
·· Development and commercialisation of proprietary
products that are marketed worldwide
·· Contract service activities based on IBA’s innovative
technologies
·· Licensing products and/or technology for research
Serving international markets directly and through a
network of distributors

People
Dr Mike Rothe (Chief Executive Officer)
Dr Joachim Bertram (Chief Scientific Officer)
Dr Herbert Stadler (Head of the Advisory Board)

10th european biotechnology guide 2020 100 | 101


Name · Immunic Therapeutics Immunic is a clinical-stage biopharmaceutical company
developing a pipeline of selective oral immunology
Address/P.O. Box ·
Am Klopferspitz 19 therapies aimed at treating chronic inflammatory and
Postal Code/City ·
82152 Planegg-Martinsried autoimmune diseases, including relapsing-remitting
Country ·
Germany multiple sclerosis, ulcerative colitis, Crohn’s disease,
Contact Person ·
Jessica Breu and psoriasis. The company’s development pipeline
(Manager IR and Communications) consists of three small molecule products: IMU-838 is
Telephone · +49-89-2080-477-61 a selective immune modulator that inhibits the intracel-
Email Address · info@imux.com lular metabolism of activated immune cells by blocking
Internet Website · www.imux.com the enzyme DHODH; IMU-935 is an inverse agonist of
Social Media · FL I the transcription factor RORγt; and IMU-856 targets
Number of Employees · 25 the restoration of intestinal barrier function by inhibiting
Founded (year) · 2016 a new and yet undisclosed target. In November 2018,
Tokyo-based Daiichi Sankyo granted Immunic an ex-
Areas of Activity · l Immunology clusive global option to license a group of compounds,
l Chronic inflammatory and designated by Immunic as IMU-856. Immunic has the
autoimmune diseases exclusive rights to commercialisation of IMU-856 in all
countries, including the United States, Europe, and Ja-
External · l Daiichi Sankyo: in November 2018, pan. Immunic exercised the option in January 2020.
Collaborations the Japanese pharma company
granted Immunic an exclusive global
option to license IMU-856. Immunic Lead programme IMU-838
exercised the option in January 2020. Immunic’s lead development programme, IMU-838, is
l Japanese pharma company, an orally available, next-generation selective immune
University of Kyoto, quattro research: modulator that inhibits the intracellular metabolism of
in support of the InnoMuNiCH project, activated immune cells by blocking the enzyme dihy-
funded by the German Ministry of droorotate dehydrogenase (DHODH). IMU-838 acts
Education and Research, Immunic on activated T and B cells while leaving other immune
together with its partners initiated a cells largely unaffected and allows the immune system
three-year research project running to stay functioning, e.g. in fighting infections. In previ-
from August 2019 to July 2022. ous trials, IMU-838 did not show an increased rate of
infections compared to a placebo. In addition, DHODH
inhibitors such as IMU-838 are known to possess a
direct antiviral effect.

IMU-838 was successfully tested in two phase 1 clini-


cal trials in 2017 and is currently being tested in phase 2
clinical trials in patients with relapsing-remitting multiple
sclerosis and ulcerative colitis. Furthermore, Immunic’s
collaboration partner, Mayo Clinic, has started an
investigator-sponsored proof-of-concept clinical trial
testing IMU-838 activity in patients with primary scleros-
ing cholangitis (PSC).
immunic therapeutics

Clinical phase 1 programme of IMU-935


IMU-935 is a highly potent and selective inverse agonist
of RORγt with additional activity on DHODH. The nuclear
receptor RORγt is believed to be the main driver for
the differentiation of Th17 cells and the expression of
cytokines involved in various inflammatory and autoim-
mune diseases. This target is believed to be an attractive
alternative to approved antibodies for targets such as
IL-23, IL-17 receptor and IL-17, itself. IMU-935 shows
strong cytokine inhibition targeting both Th17 and Th1
responses in preclinical testing, as well as indications of
activity in animal models for psoriasis and inflammatory
bowel disease. Preclinical experiments indicate that,
while leading to a potent inhibition of Th17 differentiation
and cytokine secretion, IMU-935 did not affect thymo-
cyte maturation.

IMU-935 is currently in phase 1 single and multiple as-


cending dose trials. Immunic plans to extend these stud-
ies to assess safety and mechanism-related biomarkers
in patients with psoriasis.

From inception to Nasdaq in only 3 years


Immunic AG was founded in 2016 with headquarters in
Planegg-Martinsried, Germany. Since April 2019, the
company has been operating under the name Immunic,
Inc. with its registered office in the United States and
has been trading on the Nasdaq Stock Market under
the ticker symbol ”IMUX.” The listing followed a reverse
takeover transaction with US-based Vital Therapies,
Inc., as announced in January 2019. The company’s
research and development activities continue to be
conducted in Germany.

Concurrent with the closing of the transaction, an in-


vestor syndicate that comprises LSP, Omega Funds,
Fund+, LifeCare Partners, Bayern Kapital, High-Tech
Gründer fonds, and IBG Beteiligungsgesellschaft
Sachsen-Anhalt invested EUR 26.7 million in the com-
pany. In September 2016, Immunic completed a series
A financing round of 31.7 million euros.

10th european biotechnology guide 2020 102 | 103


Name · Indivumed GmbH Company overview
Indivumed, founded in 2002, is one of the first compa-
Address/P.O. Box · Falkenried 88 – Bldg. D nies in the field of personalised cancer therapy focused
Postal Code/City · 20251 Hamburg on the phenoytypic characterisation of cancer in indi-
Country · Germany vidual patients. A major challenge for researchers is that
Contact Persons · Prof. Dr Hartmut Juhl (CEO) cancer cells change expression profiles such as RNA,
Telephone · +49-40-4133-83-0 proteins, and phosphoproteins within minutes when
Fax · +49-40-4133-83-14 tissue is removed from the body.
Email · info@indivumed.com
Website · www.indivumed.com As a physician-led company with a deep understand-
Social Media · I ing of the clinical environment and challenges involved
Number of Employees · >200 implementing science-guided structures, Indivumed
Founded (year) · 2002 has resolutely addressed this problem. Since 2002, In-
Type of Laboratory · L2, S1 divumed has developed and implemented >130 SOPs in
Areas of Activity · Service and partnering in the field of a collaborative network of more than 50 cancer clinics in
personalized cancer medicine; Europe, North America, and Asia. Indivumed guarantees
international standardisation of tissue, identical collection and processing standards for tissue
blood and clinical data collection in and clinical data from all kinds of solid tumours from tens
>50 cancer clinics in Europe, North- of thousands of patients annually. There are no variances
America and Asia; multiomics analysis in biospecimen quality and clinical data regardless of the
of cancer tissue combining WGS with hospital and region where patients are treated.
proteomics, phosphoproteomics, and
immunophenotyping; Data analysis Besides this unique resource for R&D, Indivumed is
using bioinformatics, artificial collaborating with pathology institutes worldwide to
intelligence, and other tools. Various obain “Routine Pathology Samples” representing tissue
kinds of laboratory services for target and data used for routine diagnostics nowadays. This
and biomarker development resource enables us to translate findings and assays
Biological Patents · INDIVUMED has been granted several from the routine world of current pathology practice.
patents relating to cancer biomarkers.
External · INDIVUMED has developed a unique
Collaborations collaborative network with leading Service & partnering
cancer clinics in Germany, India, Two business units offer customers individualised serv-
Poland, and the US, as well as with ices and collaborative partnerships, respectively.
biopharmaceutical companies and
academic institutions worldwide, IndivuServ
including the Salk Institute, Georgetown At IndivuServ we provide a wide range of ISO-certified
University, University of Rochester and GCP-compliant services based on our biobank and
Medical Center in the US, and the Astar state-of-the-art laboratory. These services include:
Institute for Molecular and Cell Biology ·· access to biospecimens from our “Indivumed Stand-
in Singapore. ard” surgical biobank, routine pathology biobank,
Request for · INDIVUMED intends to enter into and our special longitudinal plasma biobank col-
Further Collaborations strategic collaborations with industry lected from medically treated cancer patients in on-
partners for the joint development of cology to perform nucleic acid testing (e.g. free cir-
cancer diagnostics and therapeutics. culating tumour DNA)
Indivumed

·· immunohistochemistry assay development and tissue


analysis for target validation and companion diagnos-
tics development
·· research services of various kinds including immuno-
oncology phenotyping of tumours and drug testing
in viable organoid tissue cultures (e.g., immuno-
oncology compound testing)

IndivuType
Understanding the full complexity of cancer biology
requires a comprehensive approach that goes beyond
genomics. Genes are transcribed and expressed in
different ways and only a multiomics view (integrating
whole genome sequencing, transcriptomics, proteom-
ics, phosphoproteomics, and immuno-phenotyping)
can provide the full picture. IndivuType is a global
database providing all this biological information and
related clinical data from thousands of cases across
multiple cancer entities worldwide. The high standardi-
sation in sample and data collection, growing number
of cases, depth of information, quality of bioinformat-
ics, and supporting analytical tools make IndivuType a
unique resource for cancer researchers and drug and
diagnostic developers. Broad access to IndivuType
and its tools is mainly provided as part of collaborative
partnership projects, although limited datasets are
available to cancer researchers worldwide based on
specific license agreements.

Executive managment team


Prof. Dr Hartmut Juhl (CEO)
Fernando Andreu (CBO)
Dr Susanne Arbogast (CMO)
Dr Nils Clausnitzer (COO)
Nils Schumacher (CLPO)

Financing
INDIVUMED generates revenue through the commerciali-
sation of its products and services. To build IndivuType,
the first multiomics cancer database, it has received
funds from private investors and the European Invest-
ment Bank.

10th european biotechnology guide 2020 104 | 105


innovating vaccines

Name · Intravacc Intravacc


Intravacc is a renowned, not-for-profit R&D organisation
Address/P.O. Box · Antonie van Leeuwenhoeklaan 9 with 100+ years’ experience in vaccine development.
Postal Code/City · 3721 MA Bilthoven We optimise vaccines, vaccine processes and vaccine
Country · The Netherlands technologies. Intravacc reduces the risks and costs
Contact Person · Tjeerd van Dijk involved with developing vaccines by bridging the gap
(Business Developer & Licensing) between concept and late-stage clinical studies.
Telephone · +31-30-7920300
Email Address · businessdevelopment@intravacc.nl
Internet Website · www.intravacc.nl Viral vaccine technology
Number of Employees · 150 For new viral vaccine development, we use established
Type of Laboratory · ML-II blue-prints and scalable platform production process-
BSL-2 es, including those based on an available scale-down
BSL-3 process for IPV. Our proven technologies are based
on Intravacc’s long-standing experience with oral and
Areas of Activity · l Vaccine development inactivated poliovirus vaccines and include virus seed
l Process and assay development strains recovery from synthetic viral genomes, cell and
l Animal models virus culture technology, virus harvest and clarification,
l (Pilot) Production, QC & QA purification, formulation, and freeze-drying, with all
l Clinical and regulatory affairs analytical assays required for in-process controls and
product release. Our viral vaccine platform makes use
External · l Academia of Intravacc’s established WHO pre-qualified Vero cell
Collaborations l Public health organisations (WHO, line. In this way, we can demonstrate fast-track proof-of-
BMGF) principle of a pilot process for various viral vaccines, as
l Biotech and pharmaceutical recently shown for Sabin-IPV, OPV, RSV, EV71, CVA16,
companies and Rota vaccine concepts, using a science-based
quality-by-design approach.

Bacterial vaccine technology


For the development of vaccines against bacterial
pathogens, Intravacc has designed and developed, in
addition to conjugate vaccine technologies, a unique
platform based on outer membrane vesicles (OMVs) –
spherical particles with natural adjuvant properties that
harbour many antigens. Using genetic engineering, the
OMVs can be decorated with the desired antigen(s) in
the required amounts that maintain their native confor-
mation. Heterologous OMVs are a suitable alternative for
pathogens that require a high containment, are difficult
to cultivate, or contain viral and/or parasitic proteins.
The antigens of choice are placed in an “empty” OMV.
We have developed genetic tools to increase yield,
reduce toxicity, and achieve the desired antigenic com-
Intravacc

position. A robust, scalable GMP production process is


operational.

Vaccine design
Our broad technological capabilities including (physico)
chemical analyses, molecular biology, proteomics, im-
munological read-out, and mass spectrometry allow us
to guide your innovative vaccine concept through the
development chain. Advanced LC-MS analysis allows
us to provide state-of-the-art knowledge and know-how
in protein characterisation.

As a front-runner in applied research on mucosal and


intradermal delivery we can create value for promising
delivery technologies. Our formulation team can help
to produce safe, affordable vaccines by using the right
excipients. The production of combination vaccines,
lyophilisation and spray-drying, stabilisation, and the
use of proprietary adjuvants (like modified aluminum and
our detoxified LPS mutants) can serve to complement
your concept.

Animal models and 3Rs


Intravacc has three state-of-the-art animal laboratory
facilities for housing different species of experimental
animals, e.g. (transgenic) mice, rats, cotton rats, ferrets,
guinea pigs, and rabbits. Moreover, it is Intravacc’s
ambition to replace the use of animals for routine lot
release testing of vaccines with innovative animal-free
techniques and to improve the scientific substantiation
of these methods. Therefore Intravacc has developed
several methods based on the 3R’s (reduction, refine-
ment & replacement).

You can find more information on www.intravacc.nl.

10th european biotechnology guide 2020 106 | 107


Name · InVivo BioTech Services GmbH Company Profile
InVivo is one of the leading contract manufacturing or-
Address/P.O. Box · Neuendorfstr. 24a ganizations in Europe, with more 20 years of experience
Postal Code/City · 16761 Hennigsdorf in mammalian cell culture and protein production.
Country · Germany
Contact Person · Dr Susanne Wolfenstetter
Telephone · +49-3302-883-769 Rely on our experience!
Fax · +49-3302-883-771 As a trusted provider of cost-effective outsourcing solu-
Email Address · info.invivo@bruker.com tions, InVivo has worked with a large number of satisfied
Internet Website · www.invivo.de clients worldwide. Companies of all sizes, including
Social Media · I small university spin-offs, major research institutes, and
Number of Employees · 70 biopharmaceutical companies, have taken advantage of
Founded (year) · 1998 our expertise as an independent contract manufacturer.
Type of Laboratory · S1, ISO 9001:2015, ISO 13485:2016 Our goal is to create lasting relationships by providing
outstanding services and highly customised solutions
Areas of Activity · l Contract manufacturing for every client’s needs.
l Production and development of
immunoassays
l Cell line development for pre-clinical We value quality!
and research use As an ISO 9001 and ISO 13485 certified company, we
always aim for the highest quality standard. Our experi-
External · Collaborations with research ence in downstream processing and protein purification
Collaborations institutions and industrial partners together with thorough quality control ensure that you
get exactly the product you’re looking for.

Service portfolio
InVivo’s service portfolio covers the full range of methods
and techniques commonly used in modern biochemistry,
cell culture, and large-scale protein expression.

Monoclonal antibody production


InVivo provides custom monoclonal antibody produc-
tion from your hybridoma line. Our facilities allow the
production of up to 1kg monoclonal antibodies for use
in research or preclinical development, human in-vitro
diagnostic, veterinary diagnostics, as well as food and
feed safety. Proprietary serum-free media and optimised
processes like high cell-density fermentation guarantee
the highest cost-effectiveness in production.

Challenging clones and antibodies receive expert at-


tention and all our processes can be adapted to your
specific needs.
invivo biotech services

Recombinant protein production


InVivo offers various different expression systems. Our
protein experts are happy to assist you in choosing the
right one for your application.

Mammalian expression systems


Bypassing the time-consuming and costly generation
of stable cell lines, InVivo’s optimised system for large-
scale transient gene expression, InVEST, facilitates the
rapid production of mammalian-derived recombinant
proteins in only a few weeks.

InVEST combines an optimised host cell line, customised


media, large-scale plasmid preparation, sophisticated
vector design, and a novel polycationic transfection rea-
gent. This allows an increase in production up to 80-fold
compared to other commercially available systems.
·· Complex proteins with post-translational modifica-
tions, such as antigens, recombinant antibodies,
antibody fragments, proteases, tumour markers, or
proteohormones
·· Yield: milligram to gram amounts
·· Timeline: 8–12 weeks

Bacterial expression systems:


The E. coli expression system for production of recom-
binant proteins offers several advantages: a shorter
timeline for the entire procedure from cloning to protein
recovery, inexpensive production process, and high
protein yields. InVivo offers large flexibility in scale, from
2L shake flask to 50L bioreactor, so you can choose
depending on your needs.
·· Smaller peptides and proteins without posttransla-
tional modifications, such as antigens, bacterial
proteins, hormones, pro-hormones, tumour markers,
or cytokines
·· High yield up to 5g/batch
·· Timeline: 4–8 weeks

Additional services
·· Hybridoma Development
·· Stable CHO cell line development
·· Immunoassay development and production

10th european biotechnology guide 2020 108 | 109


Name · KAIROS GmbH The KAIROS GmbH is an IT specialist with more than
ten years of experience in the development of IT system
Address/P.O. Box · Universitätsstraße 136 solutions for the healthcare sector. In addition to spe-
Postal Code/City · 44799 Bochum cial technological knowledge in the implementation of
Country · Germany medical middleware platforms, we have extensive know-
Contact Person · Dirk Link how in the IT-supported orchestration of workflows via
Telephone · +49-234-588821-15 workflow engines.
Fax · +49-234-588821-21
Email Address · dirk.link@kairos.de Especially in the areas of preclinical, biobanking, and
Internet Websites · www.kairos.de study management, our CentraXX product solution is a
www.kairos.us unique knowledge portal that covers all current require-
Social Media · FL I Q ments and is adapted and constantly expanded in line
Number of Employees · 40 with current requirements.
Founded (year) · 2008

Areas of Activity · Development of IT solutions for study CentraXX – so much more than “just”
management and biobanking a biotech solution
With CentraXX, KAIROS offers a biomedical research
portal that has already incorporated the principles of
personalised medicine into its product DNA.

The CentraXX research portal focuses on the structured


capturing of research content through the biobanking
and study management modules. In particular, the con-
nection to the treatment data is established by means
of a comprehensive data-capturing pipeline.

The provision of treatment data for research in particular


reveals new contexts of meaning. Thus, important find-
ings – such as the comparison of patients with similar
cases – can be offered via the portal. Features such as
age, diagnosis, therapy, pathological descriptions, and
laboratory values are no longer sufficient, as individual
values, for the comparison of diseases in the context
of personalised medicine. IT-supported predictions and
therapy suggestions, using the combined data, can then
be made from this symbiosis.

With the aim of developing a system IT solution that pro-


vides the overdue technical foundation for translational
biotechnological research, we have purposefully and
dynamically expanded CentraXX into a genuine research
portal for the entire field of medical research.
kairos

To this end, we have developed numerous modular


products that can be used as complex system solutions
if required from the pure biobank solution CentraXX Bio
through to the complete Clinical Trial Management System
(CTMS) with integrated tools such as the Meta Data Re-
pository (CentraXX MDR), the Raw Data Archive Module
(CentraXX RDA), and the CentraXX Patient App.

CentraXX – the expert system for


biobanking and research
Today CentraXX is used in 30 of the 35 university hos-
pitals in Germany. In addition to the largest nationwide
long-term study, the NAKO Health Study (NAKO), three
BIOBANKING | RESEARCH PORTAL | STUDY RECORDS | CONSENT MANAGEMENT | CENTRAXX BIO | SAMPLE DOCUMENTATION |
of the six German Centres for Health Research (DZG)
WORKFLOW ENGINE
PATIENT DATA | BIOSAMPLE MANAGEMENT | PERSONALIZED MEDICINE | WORKFLOW ENGINE | WORKFLOW ENGINE | SAMPLE DATA
are already using CentraXX.
RESEARCH PORTAL
| PSEUDONYMIZATION | BIOBANKING | RESEARCH PORTAL | STUDY RECORDS | CONSENT MANAGEMENT | CENTRAXX BIO | SAMPLE
DOCUMENTATION | PATIENT DATA | BIOSAMPLE MANAGEMENT | PERSONALIZED MEDICINE | WORKFLOW ENGINE | WORKFLOW
ENGINE | SAMPLE DATA | PSEUDONYMIZATION | BIOBANKING | RESEARCH PORTAL | STUDY RECORDS | CONSENT MANAGEMENT |
CENTRAXX BIO | SAMPLE DOCUMENTATION | PATIENT DATA | BIOSAMPLE MANAGEMENT | PERSONALIZED MEDICINE | WORKFLOW
Numerous renowned research institutes – but also
SAMPLE DOCUMENTATION
ENGINE | WORKFLOW ENGINE | SAMPLE DATA | PSEUDONYMIZATION | BIOBANKING | RESEARCH PORTAL | STUDY RECORDS |

CENTRAXX BIO
CONSENT MANAGEMENT | CENTRAXX BIO | SAMPLE DOCUMENTATION | PATIENT DATA | BIOSAMPLE MANAGEMENT | PERSONALIZED
increasingly prospering BIOTECH companies both in
MEDICINE | WORKFLOW ENGINE | WORKFLOW ENGINE | SAMPLE DATA | PSEUDONYMIZATION | BIOBANKING | RESEARCH PORTAL |
STUDY RECORDS | CONSENT MANAGEMENT | CENTRAXX BIO | SAMPLE DOCUMENTATION | PATIENT DATA | BIOSAMPLE MANAGEMENT
Germany and on the North American market – are now
BIOBANKING
| PERSONALIZED MEDICINE | WORKFLOW ENGINE | WORKFLOW ENGINE | SAMPLE DATA | PSEUDONYMIZATION | BIOBANKING
| RESEARCH PORTAL | STUDY RECORDS | CONSENT MANAGEMENT | CENTRAXX BIO | SAMPLE DOCUMENTATION | PATIENT
among the users of CentraXX.
DATA | BIOSAMPLE MANAGEMENT | PERSONALIZED MEDICINE | WORKFLOW ENGINE | WORKFLOW ENGINE | SAMPLE DATA |

PSEUDONYMIZATION
PSEUDONYMIZATION | BIOBANKING | RESEARCH PORTAL | STUDY RECORDS | CONSENT MANAGEMENT | CENTRAXX BIO | SAMPLE
DOCUMENTATION | PATIENT DATA | BIOSAMPLE MANAGEMENT | PERSONALIZED MEDICINE | WORKFLOW ENGINE | WORKFLOW

PERSONALIZED MEDICINE
ENGINE | SAMPLE DATA | PSEUDONYMIZATION | BIOBANKING | RESEARCH PORTAL | STUDY RECORDS | CONSENT MANAGEMENT
| CENTRAXX BIO | SAMPLE DOCUMENTATION | PATIENT DATA | BIOSAMPLE MANAGEMENT | PERSONALIZED MEDICINE | WORKFLOW
For this reason, KAIROS has also implemented a certified
STUDY RECORDS
ENGINE | WORKFLOW ENGINE | SAMPLE DATA | PSEUDONYMIZATION | BIOBANKING | RESEARCH PORTAL | STUDY RECORDS |
CONSENT MANAGEMENT | CENTRAXX BIO | SAMPLE DOCUMENTATION | PATIENT DATA | BIOSAMPLE MANAGEMENT | PERSONALIZED
QMS according to DIN EN ISO 13485 for the development
PATIENT DATA
MEDICINE | WORKFLOW ENGINE | WORKFLOW ENGINE | SAMPLE DATA | PSEUDONYMIZATION | BIOBANKING | RESEARCH
PORTAL | STUDY RECORDS | CONSENT MANAGEMENT | CENTRAXX BIO | SAMPLE DOCUMENTATION | PATIENT DATA | BIOSAMPLE
of medical products. Research data can only be returned
MANAGEMENT | PERSONALIZED MEDICINE | WORKFLOW ENGINE | WORKFLOW ENGINE | SAMPLE DATA | PSEUDONYMIZATION |
to the treatment process via this path, which is specified
BIOSAMPLE MANAGEMENT
BIOBANKING | RESEARCH PORTAL | STUDY RECORDS | CONSENT MANAGEMENT | CENTRAXX BIO | SAMPLE DOCUMENTATION |
PATIENT DATA | BIOSAMPLE MANAGEMENT | PERSONALIZED MEDICINE | WORKFLOW ENGINE | WORKFLOW ENGINE | SAMPLE DATA
in accordance with DIN EN ISO 13485.
| PSEUDONYMIZATION | BIOBANKING | RESEARCH PORTAL | STUDY RECORDS | CONSENT MANAGEMENT | CENTRAXX BIO | SAMPLE

SAMPLE DATA
DOCUMENTATION | PATIENT DATA | BIOSAMPLE MANAGEMENT | PERSONALIZED MEDICINE | WORKFLOW ENGINE | WORKFLOW ENGINE
| SAMPLE DATA | PSEUDONYMIZATION | BIOBANKING | RESEARCH PORTAL | STUDY RECORDS | CONSENT MANAGEMENT | CENTRAXX

CONSENT MANAGEMENT
BIO | SAMPLE DOCUMENTATION | PATIENT DATA | BIOSAMPLE MANAGEMENT | PERSONALIZED MEDICINE | WORKFLOW ENGINE |
WORKFLOW ENGINE | SAMPLE DATA | PSEUDONYMIZATION | BIOBANKING | RESEARCH PORTAL | STUDY RECORDS | CONSENT

10th european biotechnology guide 2020 110 | 111


Name · Labor Dr. Merk & Kollegen GmbH Excellence in virology
Labor Dr. Merk & Kollegen GmbH (LMK), GMP and GLP
Address/P.O. Box · Beim Braunland 1 certified, is a centre of excellence for virology, pioneer-
Postal Code/City · 88416 Ochsenhausen ing viral characterisation, MVB and WVB establishment,
Country · Germany raw material testing, microbial and viral disinfectants
Contact Person · Dr Ingrid Rapp testing, vaccine release testing, and viral clearance
Telephone · +49-7352-911930 studies, with more than 40 different high titre purified
Fax · +49-7352-911940 viruses from animal and human origin available.
Email Address · info@labormerk.de
Internet Website · www.labormerk.de History
Founded (year) · 1971 Founded in 1971, LMK is a family-owned company
Type of Laboratory · S2 based in Ochsenhausen, Germany with more than 90
employees with outstanding expertise, training, and
Areas of Activity · l Process development specialisation in virology, with EMA approval for release
l GMP manufacturing of viral testing of vaccines produced outside of Europe, serving
therapeutics the health and welfare of our global population.
l Biosafety testing in virology and
microbiology Viral therapeutics
l Cell-based assays LMK offers process development and GMP manu-
l Analytics facturing of viral gene therapeutics and oncolytic viral
therapeutics as well as vaccines. LMK operates as a full
CDMO with end-to-end process development, manu-
facturing of drug substances and drug products with
analytical characterisation, and regulatory support.

Upstream processing
For manufacturing of a broad range of viral therapeutics
such as adenoviruses, adeno-associated viruses, lenti-
viruses, VSV, and parapox viruses, LMK has established
adherent cell technologies in T-flasks, cell factories,
and iCELLis, and suspension cell culture technologies
with chemically defined media, and feeding systems in
SUB. LMK also has the expertise to convert adherent
processes to safer and simpler scalable suspension
processes up to BSL-2.

LMK performs MCB and WCB of a broad range of cell


lines suitable for viral propagation and has an extended
media screening programme for cell line growth and
virus titre performance.

Harvest systems by depth filtration are available, as well


as cell disruption for release of viruses, if required.
labor dr. merk & Kollegen

Downstream processing
In downstream processes LMK operates AIEX and CIEX
chromatography as well as adsorber membranes, al-
lowing separation of full and empty capsids as well as
affinity chromatography for capturing viruses from cell
culture fluid in high purity, low HCP content, high titre,
and high yield. For formulation LMK offers thermo-stable
formulations for viral therapeutics as well as fill & finish
in liquid or lyophilised form up to BSL-2. Stability testing
is performed according to ICH guidelines. All processes
are scalable for industrial manufacturing for clinical
supply by LMK.

Analytics
LMK offers a broad spectrum of analytical methods for
determining purity, efficiency, and safety of viral thera-
peutics and vaccines, including a variety of bio- and
cell-based assays. This also includes but is not limited
to the determination of empty and full capsids, infectious
and genomic virus particles, and virus aggregates.

CRO/CDMO business
Customers of LMK range from biotech startup com-
panies to Big Pharma. LMK has collaborations with
academia to improve their state-of-the-art technologies,
including universities in Aachen, Biberach, Hannover,
Tübingen, Ulm, and Vienna.

LMK as end-to-end CDMO


·· Analytical method development
·· MVB/WVB
·· Adherent and suspension cell screening
·· Media optimization
·· MOI optimization
·· Innovative process development
·· GMP manufacturing of DS
·· Formulation development
·· Analytical characterisation
·· Regulatory support
·· Compliance with relevant guidelines

10th european biotechnology guide 2020 112 | 113


Name · Losan Pharma GmbH We make APIs perform
Losan is an innovation-driven, pharma-technology
Address/P.O. Box · Otto-Hahn-Strasse 13 company dedicated to developing and manufacturing
Postal Code/City · 79395 Neuenburg drugs that exhibit demanding formulation properties as
Country · Germany well as to significantly improving drugs in order to gen-
Telephone · +49 7631 7906 0 erate added value for customers and patients. For more
Email Address · info@losan.de than 25 years, our experienced R&D unit in Neuenburg
Internet Website · www.losan.de has supported our clients all over the world with their
Number of Employees · 570 specific and challenging projects.
Founded (year) · 1992
We offer high-quality solutions
Areas of Activity · Development and manufacture of to enhance bioavailability, improve the stability of APIs,
cutting-edge medicinal products with and provide targeted and sustained release delivery of
improved API performance and/or pharmaceutical products by applying modern pharma-
convenient application. ceutical technologies. Taste masking and new dosage
l Formulation development forms such as stick packs that increase patient compli-
l Analytical development ance are Losan’s core competencies.
l Clinical trial supply
l Contract manufacturing for We lessen the complexity for pharma
commercial supply companies
with our talented team of experts, cutting-edge tech-
Request for · We offer our services for start-ups, nologies, broad service offering, and complete scale-up
Further Collaborations small, mid-sized, and multinational capabilities from concept to commercialisation.
pharmaceutical companies worldwide.
Our highly-skilled team of formulation We provide full service supply
development experts can manage your that includes material procurement, tech transfer, pro-
pharmaceutical project requirements cess optimisation, validation, and a broad range of
from the preclinical stage right up to analytical methods testing (method transfer, method
the full-scale manufacturing of your validation, and stability studies).
product.
We can handle every aspect
For more information, please contact of manufacturing your medicinal products by offering a
us at info@losan.de. high service level and an excellent inspection history.
For our clients, Losan manufactures products that are
distributed in more than 70 countries worldwide.

In addition to the local authority inspections every two


years, Losan has also successfully passed several key
inspections, among them:
·· US-FDA
·· ANVISA
·· Russian Authority
·· Turkish Authority
losan pharma

From concept to commercialisation


As a capable and reliable one-stop innovation partner
of choice, we offer solutions for early stage formulations,
for cGMP scale-up, for innovative commercial manufac-
turing and packaging, as well as for product lifecycle
extensions.

Our technologies
·· nanomilling (wet ball)
·· hot melt extrusion
·· pellet production with extrusion spheronisation
·· fluid bed granulation / drying / coating
·· silica amorph embedding (granules)
·· dry granulation (compaction)
·· high shear wet granulation / drying
·· hot melt coating
·· spray drying
·· film coating

Our dosage forms


·· pellets
·· granules
·· effervescent granules and tablets
·· tablets, mini tablets
·· orodispersible tablets
·· buccal / sublingual forms
·· MUPS tablets
·· capsules
·· suspensions
·· suppositories

Our drug packaging


·· stick packs
·· sachets
·· blisters
·· tubes
·· bottles (plastic or glass)
·· enemas
·· specialty packaging, anti-counterfeiting, child resist-
ance
·· serialisation and aggregation

10th european biotechnology guide 2020 114 | 115


Name · Merck Biodevelopment SAS Many parameters along your journey
No two drug developments are ever the same. We un-
Address/P.O. Box · 1 rue Jacques Monod derstand you need to adapt to an unpredictable journey
Site Montesquieu with changing priorities along the way. Whether you
Postal Code/City · 33650 Martillac have never brought a product to market before or need
Country · France a CDMO that can build upon your experience, we help
Contact Person · Dr Sébastien Ribault you make the critical decisions that will impact your drug
Telephone · +33-5-57-960-960 development journey, conscious about time and cost.
Fax · +33-5-56-64-99-56
Email Address · Sebastien.ribault@merckgroup.com Adaptive CDMO Solutions
Internet Website · www.merckmillipore.com/adaptive-CDMO We offer CDMO solutions adapted to your project’s
Social Media · L (#E2EBIO) needs, even if your needs are changing. Because we are
Number of Employees · Approx. 350 a small and flexible organisation backed by Merck with
Founded (year) · 1987 more than 56.000 employees, we bring you a wealth of
Type of Laboratory · Biodevelopment center in-house expertise. We are the CDMO within Merck that
helps biotechs develop their biologic drug candidates
Areas of Activity · l Cell line development from DNA to market. We are BioReliance® End-to-End
l Cell banking Solutions.
l Process development
l Analytical development BioReliance® End-to-End Solutions
l GMP manufacturing We are an adaptive contract developer and manufac-
l Regulatory advice turer that helps start-ups and small biotechs reach their
l Process validation next milestone with the right balance between cost, risk
l Scale-up and transfer and speed to clinic and offers custom solutions and
expertise from pre-clinical to commercial:
Request for · BioReliance® End-to-End Solutions ·· Cell line development
Further Collaborations offers adaptive contract development ·· Cell banking
and manufacturing for start-ups and ·· Analytical development
small biotechs who need support and ·· Process development
expertise for their biologic drug ·· GMP manufacturing
development from DNA to market. ·· Product characterisation
·· Lot release testing
·· Process validation, scale up and transfer
·· Regulatory and Quality support

Our History
Our biodevelopment center in Martillac started in 1987
as a CDMO, which was acquired by Serono to become
an in-house discovery, development, and manufacturing
function for Merck Healthcare. Since 1995 the Martillac
site is GMP certified. The site was upgraded to a fully
single-use platform in 1992, when we began offering
again services externally and creating GMP batches
for clients. Biodevelopment centers were opened in
merck

Boston, USA and Shanghai, China in 2017 for non-GMP


clinical production. In 2020, we will open our GMP facil-
ity in Shanghai.

Our experience
·· 33 years in process development, 23 in GMP production
·· 250+ biologics (antibodies, hormones, fc-fusion and
recombinant proteins)
·· 75+ GMP Drug Substance for unique molecule re-
leased since 2012
·· 80% Fed batch, 20% Perfusion
·· 100% scale up success rate
·· 97% Clinical GMP production success rate
·· Build or expand Single-Use PD/GMP facility in <1 year

How we work with you


We start with establishing your strategy and offer cus-
tom solutions that take into account our clients’ project
needs. How fast do you need to go? What is the level
of risk you are willing to take? These are questions we
address and based on our experience we help our cli-
ents balance cost, risk and speed to clinic without ever
sacrificing quality. Our regulatory advisers represent
our clients in front of regulatory bodies to show that
patient safety is guaranteed throughout the process. Our
dedicated project managers allow us to function like an
extension of your team. We emphasise transparency and
connect you directly with our experts. When you decide
to transfer your process, we support your tech transfer
to your facility or to any partner.

What you can expect


·· A flexible approach to balancing cost, risk and speed
to clinic
·· In-house expertise that helps you take informed deci-
sions
·· Complete end-to-end or à la carte services
·· No upfront payment or booking fees
·· Freedom to tech-transfer at any stage, to any partner
·· Optionality through access to the latest technologies
and deep development expertise

Did you just get funding? Or are preparing to get to clinic and
IND filing? Contact us today to talk about your next steps.

10th european biotechnology guide 2020 116 | 117


Name · Microcoat Biotechnologie GmbH Company profile
Microcoat offers a wide range of individual and special-
Address/P.O. Box · Am Neuland 3 ised services for the diagnostic and pharmaceutical
Postal Code/City · 82347 Bernried industry. In close cooperation with our customers, we
Country · Germany aim for best performance, building on a complete range
Contact Person · Dr Andrea Gräntzdörffer of advanced technologies and uncompromised quality
(Business Development) standards.
Telephone · +49-8158-9981-34 For pharmaceutical companies, we leverage our pro-
Fax · +49-8158-9981-10 found expertise in in-vitro diagnostics and assay devel-
Email · a.graentzdoerffer@microcoat.de opment in order to become a preferred partner in early
Website · www.microcoat.de development, pre-clinical and clinical phases of drug
Social Media · I development and patient sample testing.
Number of Employees · > 150 For food safety, environmental testing and other spe-
Founded (year) · 1992 cialised diagnostic fields, Microcoat aims to be the
Type of Laboratory · S1/S2, GLP, GCP, GMP, ISO 9001, preferred OEM-partner for the development and manu-
EN ISO 13485 facturing of reliable test components and kits.

Areas of Activity · | Contract manufacturing Contract manufacturing


| Custom development Microcoat is an approved original equipment manufac-
| Laboratory services turer (OEM) for diagnostic test kits, bulk and finished
| Endotoxin and pyrogen testing service components. We manufacture according to ISO and IVD
standards. Since all critical test components are pro-
External · Business-to-business with industrial duced and modified in house, we are able to control
Collaborations partners in the pharmaceutical quality at all stages of the production process.
industry, diagnostic industry and life
science industry Production technologies:
·· Fermentation (30 litre scale)
Request for · Microcoat seeks joint projects and ·· Downstream processing
Further Collaborations service partnership with ·· Protein chemistry
pharmaceutical, biotech and ·· Microplate and particle coating
diagnostic companies, as well as with ·· Dispensing/filling/labelling
players in the field of food safety ·· Freeze-drying
testing, crop science and ·· Kit assembly
instrumentation (medical devices).
Product categories:
·· Coated microplates
·· Lateral flow test strips
·· Recombinant proteins/antigens
·· Antibody/protein conjugates
·· Liquid components
·· Dried/lyophilized components
·· Diagnostic kits
Microcoat

Custom development
Microcoat offers unique expertise in diagnostic assay and
product development. A broad spectrum of methods, skilled
staff and intensive communication with the customer are
the cornerstones of successful project execution.
Development projects are based on detailed milestone
plans and follow standardised development guidelines
through the five project phases (feasibility, development,
verification, validation and manufacturing).

We develop for you:


·· Immunological assays
·· Molecular assays
·· Sample and matrix preparation protocols
·· Depletion protocols

Laboratory services
In our certified facilities, we conduct a broad spectrum
of GLP/GCP services to support drug development
starting from early discovery to post-marketing surveil-
lance. As an independent contract research organisation
and preferred provider we serve pharma and life science
industries worldwide. Based on long lasting experience

B2B Diagnostics
in endotoxin and pyrogen testing, Microcoat offers a set
of proprietary methods and skilled scientific personnel
for non-routine projects. Services are run as flexible
customer-specified projects including the search for
root causes, exploration of realization alternatives, de-
velopment of product-specific adaptions and GMP
comliant validation of newly established methods.

Our services include:


·· Biomarker testing
·· Immunogenicity/PK assays
·· Endotoxin and pyrogen testing
·· Assay development and validation

Business model
Microcoat is focused on business-to-business with in-
dustry customers, seeking a reliable and long-lasting
partnership for outsourcing projects such as contract
manufacturing (OEM), assay and product development,
and bioanalytical testing in the context of pre-clinical
and clinical studies.

10th European biotechnology guide 2020 118 | 119


Name · Microsynth AG The Company
Microsynth is a leading European company in the field
Address/P.O. Box · Schützenstrasse 15 of nucleic acid synthesis and analysis. Its main activities
Postal Code/City · 9436 Balgach are oligonucleotide synthesis, DNA/RNA analysis and
Country · Switzerland sequencing, as well as contract research and outsourc-
Contact Person · Christof Wunderlin and ing. For three decades, the company’s goal has been to
Dr Markus Schmid (Co-CEOs) serve its customers by delivering products and services
Telephone · +41-71-722-83-33 of the highest quality, on time and with outstanding
Fax · +41-71-722-87-58 service – and all this at competitive prices. Microsynth
Email Address · info@microsynth.ch has subsidiaries in Germany (Microsynth Seqlab GmbH),
Internet Website · www.microsynth.ch Austria (Microsynth Austria GmbH), and Switzerland
Founded (year) · 1989 (ecogenics GmbH). Altogether Microsynth employs a
Type of Laboratory · S1/S2, GMP/GLP staff of about 100 people.

Areas of Activity · l Oligonucleotide synthesis


l Sanger sequencing Products and Services
l Next generation sequencing Oligonucleotide synthesis
l DNA/RNA isolation, qPCR, Customers can choose from a broad range of different
digital PCR, genotyping backbones (DNA, RNA, 2’-MOE, 2’-OMe, LNA, PTO),
l Contract research/outsourcing modifications (MGB, GalNac, >250 in total), and purifica-
tions. From small scales for primers to probes for mo-
Applications · l Contract manufacturing lecular diagnostic kits up to pilot scale for therapeutic
(e.g. ASOs, probes) oligonucleotides, Microsynth is your complete solution
l Assay development provider in the field of oligonucleotide synthesis.
l Assay validation (ICH guidelines)
l GxP(-like) analysis of customer test DNA/RNA analysis
items (Sanger, NGS, qPCR, & dPCR) With more than 25 years of experience in DNA Sanger se-
l Process outsourcing quencing, Microsynth has become one of the leading se-
l Genomics research quencing suppliers in Europe. Having established Sanger
sequencing labs in Switzerland, Austria, and Germany, we
are able to offer this service in these countries with un-
matched speed and environmentally friendly pickup ser-
vice. Microsynth’s decentralised approach results in
shorter sample delivery routes and thus to the predominant
use of bicycle- and train-based courier logistics.

Microsynth offers a wide range of high-quality next


generation sequencing services. Microsynth focuses
on the small- to medium-sized Illumina sequencing
platforms. In the fields of microbial sequencing, me-
tagenome sequencing (16S/ITS), RNA sequencing, and
deep amplicon sequencing, Microsynth offers an un-
matched service. The proprietary bioinformatics analy-
sis pipelines deliver reliable and ready-to-use results.
microsynth AG

The fast turnaround times and first-class consulting


differentiate Microsynth from its competitors.

Beyond DNA sequencing, Microsynth has built up criti-


cal expertise in related analytical areas such as nucleic
acids isolation, PCR (from classic to qPCR to digital
PCR), and genotyping (e.g. STR DNA profiling, genotyp-
ing by sequencing).

Contract research / outsourcing


Microsynth has vast experience in running many differ-
ent research projects for its customers, including the
development of new protocols. Successful projects in
basic, preclinical, and clinical research range from one-
month to multi-year projects. Experienced researchers
with a solid track record in microbiology, genomics,
molecular biology, and bioinformatics help you to define
the best strategy to address your research questions.

A broad portfolio of validated techniques and protocols


is available at Microsynth. Professional project manage-
ment, high-throughput sample logistics, and close coop-
eration with the customer ensure that every outsourced
project is completed cost-efficiently and on time.

Quality Management System


Microsynth puts every effort into constantly improving
the underlying production processes. All branches
of Microsynth are EN ISO 9001:2015 certified. The NGS
and Sanger sequencing department as well as the
parentage testing and fragment length analysis of
Microsynth AG are additionally ISO/IEC 17025:2017 ac-
credited (STS 0429). Microsynth AG is also authorised
by SwissMedic to perform quality control of medicinal
products using GMP Sanger sequencing. Further,
Microsynth AG is EN ISO 13485:2016 certified for the
analysis, production, and distribution of nucleic acids,
in-vitro diagnostic (IVD) assays, and applications.

People
Dr Markus Schmid, Christof Wunderlin (Co-CEOs)
Dr. Christoph Grünig (Head of Contract Research)

10th european biotechnology guide 2020 120 | 121


Name · Molzym GmbH & Co. KG Molzym is committed to the development of innovative
solutions for molecular biological research and diagno-
Address/P.O. Box · Mary-Astell-Straße 10 sis of pathogens. Developmental efforts of our product
Postal Code/City · 28359 Bremen lines are particularly focused on new processes ena-
Country · Germany bling and facilitating the culture-independent molecular
Contact Person · Marina Linow analysis of bacteria and fungi. High-quality products are
Telephone · +49-421-696162-0 available for pathogen DNA enrichment, isolation, and
Fax · +49-421-696162-11 molecular microbial analysis by PCR- and NGS-based
Email Address · info@molzym.com methods in 30 countries worldwide.
Internet Website · www.molzym.com
Social Media · I
Number of Employees · 20 Expertise
Founded (year) · 2003 Molzym manufactures ultra-clean and highly active
amplification reagents and kits for microbial nucleic
Areas of Activity · Manufacturer and supplier of products: acid extraction from a variety of clinical specimens.
l Microbial DNA extraction Reagents and consumables are supplied free of
(manual and automated) contaminating microbial DNA – guaranteed lot by lot.
l PCR assays and master mixes Our customers appreciate the ability to increase the
l DNA-free PCR reagents and number of amplification cycles and thus lower the limit
polymerases of detection dramatically without false positive results
l CE IVD kits for infection diagnosis arising from contaminating microbial DNA. Another core
l Customised master mixes expertise is Molzym’s unique MolYsis™ technology for
the depletion of host DNA from usually sterile human
Request for · Molzym is interested in collaborations and animal samples, a well-known factor negatively
Further Collaborations that are directed to the development influencing sensitive PCR and microbiome analysis at
and manufacturing of individualised, low microbial loads. As a result, molecular analysis is
pre-analytic, and analytic solutions, greatly increased in sensitivity and specificity.
including automation.

Research reagents
MolYsis™ is Molzym’s proprietary technology of host
DNA depletion and targeted isolation of microbial
DNA from a variety of liquid and tissue samples. The
latest development is a walk-away robotic system,
SelectNA™plus, for the fully automated host DNA
depletion and extraction of microbial DNA from clini-
cal and other material. SelectNA™plus provides the
utmost technical advances for contamination-free and
low-hands-on processing of samples for the highest
sensitivity in the detection of microbes.

Ultra-clean PCR reagents for microbe detection are free


of any contaminating microbial DNA, which prevents
false positive results, and include a highly active Taq
molzym

DNA polymerase. PCR and real-time PCR assays with


universal 16S and 18S rDNA primers are offered for the
sensitive detection of bacterial and fungal DNA, as are
basic master mixes for use with custom-designed prim-
ers and probes. Additionally, a service for the decon-
tamination of customised master mixes from microbial
DNA for improved assay performance is offered.

Clinical diagnostics
With SepsiTest™-UMD and Micro-Dx™, Molzym of-
fers two CE-marked in-vitro diagnosis solutions for
the culture-independent detection of pathogens that
cause various diseases. Both kits include reagents for
the depletion of human DNA and the targeted isolation
of microbial DNA from a variety of clinical samples, e.g.
whole blood, CSF, BAL, joint aspirates, tissue biopsies,
abscesses, and other materials. Manual DNA isola-
tion can be accomplished with SepsiTest™-UMD, and
with Micro-Dx™ the process is fully automated on the
SelectNA™plus robot. Precise detection is performed
with broad-range 16S/18S PCR and sequencing analysis
to identify the pathogens down to the species level. Both
assays are especially applicable for samples which were
negative after culturing, e.g. due to prior antibiotic treat-
ment or fastidious growth requirements.

The Molzym team appreciates your interest and is at your


disposal for further information about our products and
developmental issues. Please call at: +49-421-696162-0
or send your inquiries to info@molzym.com.

10th european biotechnology guide 2020 122 | 123


Name · MyData-TRUST Company overview
MyData-TRUST is a company specialised in data pro-
Address/P.O. Box · Boulevard Initialis, 7/3 tection and exclusively dedicated to the life sciences
Postal Code/City · 7000, Mons industry.
Country · Belgium MyData-TRUST provides strategic, operational, and
Contact Person · Gautier Sobczak organisational support, making an important contribu-
Telephone · +32-493-09-97-04 tion both legally and technically to the success of data
Email Address · g.c.sobczak@mydata-trust.com protection implementation and your company as a
Internet Website · www.mydata-trust.com whole.
Social Media · FL I  We provide service solutions aligned with both health
Number of Employees · 25 R&D and data protection requirements: GDPR, HIPAA,
Founded (year) · 2017 CCPA, Privacy Shield, and many other data protection
regulations.
Areas of Activity · l Data Protection
l Data Privacy ·· 100% dedicated to the life sciences industry: Bio-
l GDPR tech, Pharma, MedTech, CROs, eHealth, Diagnostic,
l Clinical Trials and others
·· 60% of our clients are conducting clinical trials in the
Annual Turnover · €2.5m EU
·· More than 150 customers worldwide
·· 180 compliance projects already completed and
validated by data protection authorities
·· Offices in the US and EU to facilitate communication
and operational interactions with customers
·· A unique combination of IT, legal and life sciences
experts

Our mission
MyData-TRUST has an extensive knowledge of EU
regulations and territorial scope. All our experts are
internal collaborators, certified in data protection with
experience in pharmaceutical or healthcare industries.
With our wealth of experience, we provide adapted and
personalised services according to the specific situation
of each organisation.

MyData-TRUST is committed to devoting the time and


efforts needed to deliver high-quality services and de-
velop a long-term relationship with organisations. Our
goal is to work in tandem towards both pharmaceutical
R&D and data protection compliance.
Mydata-trust

Our services
We can provide, at any stage of your data protection
implementation programme:
·· Trainings & Workshops: on site, remote, or using our
e-learning tool
·· Assessments: Gap Analysis, DPIA, Validation Assess-
ment, and Provider Audit
·· DPOaaS and DPRaaS: dedicated experts for exter-
nalisation of DPO and DPR functions
·· Legal support: for every question related to a data
protection regulation, SOP creation, contract, or
consent review

MyData-TRUST offers different collaboration models to


match your expectations and needs:
·· Fixed price projects
·· Adapted and flexible packages
·· Consulting on demand
·· On-site consultancy

MyData-TRUST guarantees full compliance with data


protection requirements and brings innovative solutions
(e.g. e-Consent, Patient Intimacy Management) that will
lead to the optimisation of your study.

10th european biotechnology guide 2020 124 | 125


be drive stay
INSPIRED DISCOVERY GENUINE

Name · New England Biolabs GmbH New England Biolabs –


be Inspired | drive Discovery | stay Genuine
Address/P.O. Box · Brüningstr. 50 – Geb. B852
Postal Code/City · 65926 Frankfurt am Main Founded in the mid-1970s as a collective of scientists
Country · Germany committed to developing innovative products for the life
Contact Person · Dr Thomas Möllenkamp sciences industry, New England Biolabs is now a rec-
Telephone · +49-69-305-23140 ognised world leader in the discovery, development,
Fax · +49-69-305-23149 and commercialisation of recombinant and native en-
Email · info.de@neb.com zymes for genomic research.
Website · www.neb-online.de
Social Media · FL I  H New England Biolabs – putting science first
Founded (year) · 1981 Created “by scientists for scientists”, NEB is renowned
for consistently providing exceptional product quality
and unsurpassed technical support. For over four dec-
ades, NEB has been shaping the landscape of bio-
science research by discovering, developing, and sup-
porting superior research reagents. In addition to NEB’s
commitment to scientific innovation and customer sat-
isfaction, NEB notably ensures the environmental sus-
tainability of the company’s business practices. Our
passion is our promise. A supplier-of-choice for scien-
tists across the globe, NEB offers the largest selection
of recombinant and native enzymes for genomic re-
search. While restriction enzymes remain part of our core
product portfolio, our ever-expanding offering also in-
cludes products related to PCR and qPCR, gene expres-
sion, sample preparation for next-generation sequencing,
synthetic biology, and CRISPR/Cas9 gene editing, as well
as glycobiology, epigenetics, and RNA analysis. A rec-
ognised leader in the field of enzymes and reagents, NEB
has earned a world-wide reputation for setting the high-
est standards for quality and value.

Basic and applied science


New England Biolabs’ laboratories more closely resemble
those of a research institute than a biotech company, and
with good reason: NEB’s scientists are engaged in re-
search in areas that include enzyme analysis and engineer-
ing, epigenetics, RNA biology, and parasitology. As a re-
sult, NEB researchers have authored or co-authored over
1,000 publications, many of which have been published in
peer-reviewed journals. To foster science education, NEB
scientists also supervise post-doctoral associates,
student interns, and PhD students engaged in research
new england biolabs

projects. With this dual focus on both basic and applied


research, NEB’s culture is collaborative and academic.

Latest innovation in enzyme technology


Our outstanding expertise in protein engineering and
evolution has led to the creation of unrivaled enzymes
and unique workflows in the library preparation and target
enrichment for the NGS space. These products set the
benchmarks for optimal performance and ease-of-use in
modern molecular biology laboratories. Moreover, NEB’s
specialised offerings for alternative DNA Assembly &
Cloning methods as well as novel reagents for CRSIPR/
Cas9 based Genome Editing makes us a first-choice
supplier for today’s molecular biologists.

Quality, customer service,


and the environment
NEB is dedicated to providing research products of the
highest quality. We are committed to processes that
ensure the protection of the environment and our inte-
grated quality and environmental management systems
are certified to meet the requirements according to the
standards ISO13485, ISO9001, and ISO14001.

Customised Solutions/OEM/GMP
NEB’s OEM business unit has been delivering custom-
ised manufacturing, tailor-made enzyme formulations,
and packaging solutions to customers for over 25 years.
Enzymes & Reagents for: Relying on this extensive experience, we have recently
completed building a new GMP manufacturing facility
Sample Preparation for Genome Editing to offer a select set of tailor-made products enabling
Next-Gen-Seq RNA Analysis OEM customers and partners to use NEB’s top-class
Genomics

qPCR
Synthetic Biology
Amplification DNA products directly in their specific applications, or to bring
them to regulated markets.

Glycobiology Cloning PCR Modification New England Biolabs GmbH

RNA Epigenetics
The NEB subsidiary in Germany represents the service
Cellular Analysis Competent Cells hub for Central Europe. From our location in Frankfurt,
Gene Expression we serve scientists and industry customers in Germany,
Protein Expression and Austria and support our network of distribution
Nucleic Acid Purification CRISPR/Cas partners across Europe.

For up-to-date information please visit our web site at


www.neb-online.de www.neb-online.de.

10th european biotechnology guide 2020 126 | 127


Guide_2017.indd 1 26.09.17 15:13
Name · Novaliq GmbH The organisation
Novaliq is a pharmaceutical company focusing on the
Address/P.O. Box · Im Neuenheimer Feld 515 development and commercialization of first- and best-
Postal Code/City · 69120 Heidelberg in-class ocular therapeutics based on EyeSol ®, the
Countrry · Germany worldwide first water-free eye drop technology.
Contact Person · Dr Christian Roesky
Telephone · +49-6221-502590
Fax · +49-6221-5025921 Business strategy
Email · info@novaliq.com Novaliq’s mission is to transform Active Pharmaceutical
Website · www.novaliq.com Ingredients (APIs) into highly effective ocular therapeu-
Number of Employees · 50 tics for both the front and the back of the eye.
Founded (year) · 2007 All product developments are based on Novaliq’s pro-
Type of Laboratory · l Chemical prietary, water-free technology called EyeSol®.
l Pharmaceutical

Areas of Activity · l Specialty pharma Water-free technology


l Ophthalmology EyeSol® is the first and only technology to overcome
the limitations of water-based eye drops, creating novel
Biological Patents · 42 patent families with a total drugs with added value such as better bioavailability,
of 106 patents issued for all key efficacy, stability, and tolerability.
pharmaceutical markets EyeSol® is clinically validated by several NovaTears®,
NOV03 and CyclASol® trials.
External · l Johns Hopkins University,
Collaborations Baltimore, USA
l Universidad Miguel Hernandez-CSIC, Product pipeline
Sant Joan d’Alacant, Spain Novaliq offers an industry-leading portfolio addressing
l University of Auckland, Australia today’s unmet medical needs of millions of patients with
l University of Cologne, Germany eye diseases.

Request for · With its fast and proven drug


Further Collaborations development process and its rich NOV03
pipeline of differentiated products, NOV03 (perfluorohexyloctane) is being developed as
Novaliq provides a unique opportunity a treatment for patients with dry eye disease (DED)
for industry and academic partners. associated with Meibomian gland dysfunction and
has a novel mode of action that has been confirmed in
various studies.

Several clinical trials have demonstrated that NOV03


stabilizes the tear film lipid layer and protects from
excessive evaporation. In addition, it has been shown
to penetrate into the meibomian glands and liquefy
secretions there, improving the quality of the meibum
and the tear film lipid layer.
novaliq

NOV03 is being developed in phase 3 (SEECASE-2 trial)


for the treatment of dry eye disease associated with
Meibomian gland dysfunction (MGD) in the USA.

CyclASol®
CyclASol® is an anti-inflammatory investigational drug
for patients with moderate to severe DED with an inflam-
matory disease component.

CyclASol® contains cyclosporine A 0.1% in EyeSol® and


holds the promise of unfolding cyclosporine A’s full po-
tential on the ocular surface enabling clinicians to treat
more patients successfully.

CyclASol® is in phase 3 development for the treatment


of dry eye disease in the USA.

NovaTears®
NovaTears® is the first and only treatment specifically
designed to treat dry eye disease. It
·· Immediately stabilizes lipid layer without vision blurring
·· Restores the tear film by increasing tear film and lipid
layer thickness for patients with a tear-lipid dysfunction
·· Is pure – contains no surfactants or preservatives

NovaTears® is based on Novaliq’s proprietary drug de-


livery technology EyeSol® which enhances the topical
bio-availability and stability of unstable APIs improving
the delivery, efficacy and convenience of treatments
for ocular surface diseases, including dry eye, through
preservative-free, multi-dose formulations.

Management
Dr Christian Roesky (CEO)
Dr Oliver Schlüter (CFO)

Important notice: NOV03 and CyclASol® are investigational new


drugs. NOV03 & CyclASol® are in late stage clinical evaluation in the
US with an open IND by the US Food and Drug Administration.

10th european biotechnology guide 2020 128 | 129


Name · NSF International The Company
Pharmaceutical and biotech companies are being chal-
Address/P.O. Box · The Georgian House, 22/24 West End, lenged by increasingly complex supply chains, ever-
Kirkbymoorside changing regulations, and a volatile and uncertain
Postal Code/City · YO62 6AF, York global environment where patients and health care
Country · United Kingdom providers expect affordable, high quality medicines.
Contact Person · John Johnson At NSF we have over 30 years of industry experience.
Telephone · +44-1751-432-999 We have stood in your shoes and we understand your
Email · johnjohnson@nsf.org challenges. Our education programmes are designed
Website · www.nsfpharma.org to change behaviours and improve workplace practices,
Social Media · I not just to pass on information. Our consultancy and
Founded (year) · 1944 auditing services have one objective in mind, to help
improve your productivity (efficiency and profit) and
Areas of Activity · l Auditing regulatory compliance. Let us help you to future-proof
l Consulting your organisation.
l Training
What Makes NSF Different?
·· Relationships matter to us. We care about you, the
client, which is why over 85% stay with us – because
we care about their future.
·· We don’t believe in off-the-shelf solutions; we provide
customised solutions and improvements that work
for your organisation.
·· We leave you feeling prepared. We work with you to
improve your internal skills and competences to build
your own sustainable quality systems.
·· Our unique team of ex-regulatory agency inspectors
and industry experts allows us to combine global
regulatory knowledge with industry best practices.

Consulting
Contact us if you want to be proactive and drive improve-
ment, or if you require guidance on a specific regulatory
or technical issue. Our consultancy services include:
·· Development and implementation of cost-effective,
compliant pharmaceutical quality systems
·· Advice on design, qualification, and validation of new
facilities, equipment, computerised systems, and
processes
·· Legal and regulatory issue guidance
·· Assistance with responses to regulatory inspection
reports
·· Simplification of quality processes, SOPs, and batch
records
NSF International

Auditing
Whether you are looking for an in-depth assessment of
a specific technical issue or to outsource your entire
supplier audit programme, our specialist auditing serv-
ices can be tailored to your specific needs and include:
·· Due diligence audits
·· Compliance auditing – assessment of activities against
standards
·· Inspection readiness audits
·· Auditing your supplier and your internal audit proc-
esses

We provide auditing services for active pharmaceutical


ingredients, excipients, medicinal product manufactur-
ers, distributors, QC laboratories, computerised sys-
tems and more.

Training and Education


We offer customised on-site pharmaceutical training,
residential courses, and eLearning covering a range of
topics.
Our GMP for Biological and Biotechnology Products
course takes place at NIBRT’s award-winning biotech
facility in Dublin, Ireland. By interacting with our experts
and taking part in plant tours, you will gain insight into
internationally recognised current Good Manufacturing
Practice (cGMP) expectations concerning a range of
bioprocesses.
New for 2020 is our Introduction to Biological and Bio-
tech Drug Substances Including ATMPs course. This
training will provide you with a unique introduction to the
key cGMP expectations associated with the manufac-
ture and QC characterisation of biological and biotech-
derived drug substances.

For our full list of courses visit:


www.nsf.org/info/pharma-training.

For more information about our services, visit:


www.nsfpharma.org, email pharmamail@nsf.org,
or call +44 1751 432 999.

10th european biotechnology guide 2020 130 | 131


2
Name · OP2 Drugs SAS (“OP2”) Persons collapses every 40 sec in the US, felles by a
heart attack. And their heart muscles will never recover
Address/P.O. Box · PTIB, Hôp. Xavier Arnozan their original contractility, leading to death or heart
Av. du Haut Lévêque failure, one of the major causes of expenses for the US
Postal Code/City · 33600 Pessac and EU healthcare systems.
Country · France
Contact Person · Fred Marin OP2 Drugs SAS (“OP2”), founded in 2015 by cardiolo-
Telephone · +33-685-833-905 gists and entrepreneurs who believe that energy dereg-
Email Address · Fred@op2drugs.com ulation is key in the development of heart dysfunctions,
Number of Employees · 4 designs, develops, and seeks to register and market
Founded (year) · 2015 breakthrough drug therapies for cardiac disorders,
characterised in collaboration with the LIRYC Institute
Areas of Activity · Drug development until registration, (FR) and the Buck Institute for Aging (US).
repositioning, cardiology, diabetes

External · IHU LIRYC (FR) Cardioprotection, a still unmet need


Collaborations after 50 years of drug candidate failures
Myocardial infarction (MI) is an irreversible necrosis
(as of 2019) lesion starting with the obliteration of a coronary artery
due to a blood clot, leading to a loss of the contractil-
ity of the lesion area in the muscle. The necrosis area
develops in two phases; the final, called the reperfusion
phase, after removal of the clot, is due to the release of
large amounts of reactive oxygen species (ROS) from
muscle cells, leading to their death.

Our first market is made of the 300,000 MI patients


yearly treated by angioplasty, the MI reference emer-
gency treatment. Indeed, our lead product, called
Myosave*, is perfused as an add-on to the angioplasty
procedure after reperfusion, during the hospital stay of
the patient, and dramatically protects against reper-
fusion damage.

European
Member of Biotechnology
NET WORK
op2

1st active ingredient to specifically


modulate mito-ROS production
OP2 has been working over the last 3 years on a first-
in-class molecule, OP2113, which has been shown to
inhibit the main source of ROS release from the mito-
chondria. On a large animal model of MI, OP2113 has
been generating impressive preclinical results.

That molecule also benefits from 70 years of marketing in


the EU in a chronic clinical setting, in an oral formulation,
and has been shown to be extremely safe.

1st ever in silico clinical development for


NDA
With the aim of supplying the first cardioprotective drug
in MI to the US market by 2023, OP2 is innovating with
the FDA to develop and validate modeling and simulat-
ing algorithms to secure Myosave* clinical development,
increase the success rate at registration, and speed up
access to the US market.

10th european biotechnology guide 2020 132 | 133


Name · OPIS s.r.l. Our organisation
OPIS is a European clinical CRO providing premium
Address/P.O. Box · Via Matteotti 10 clinical trial management for multi-country trials. In ad-
Postal Code/City · 20832 Desio dition to phase I-IV drug-related trials, OPIS also man-
Country · Italy ages pre- and post-marketing clinical investigations for
Contact Person · Giovanni Trolese medical and diagnostic devices, as wela as nutraceuti-
Telephone · +39-0362-633-1 cal/food supplement studies.
Fax · +39-0362-633-633 Founded in 1998, OPIS is a premium European CRO,
Email Address · office@opiseurope.com with roughly 240 employees. The company operates
Internet Website · www.opiseurope.com from its Italian headquarters and eight offices located
www.clinical.net in Europe (Spain, France, Germany, UK, Belgium, Swe-
Social Media · I den, Poland, and Switzerland).
Number of Employees · ca. 240
Founded (year) · 1998
Our expertise
Areas of Activity · Premium support for clinical drug In 21 years of combining medical, regulatory, statistical,
and device development and technological expertise, OPIS has assisted a huge
number of different clients with interventional and ob-
Annual Turnover · € 24 m servational trials.
Full-service projects in a wide range of therapeutic ar-
External · Pharma eas include various rare disease indications as well as
Collaborations pediatric studies. Currently, over 40% of trials managed
by OPIS are oncology or onco-hematology trials. Other
Request for · l Pharma major therapeutic areas include ophthalmology, neurol-
Further Collaborations l Biotech ogy, and cardiology.
l Medical device OPIS has established a solid collaboration with numer-
l Food supplements ous international sponsors on multi-country trials.

Our mission
We draw on our know-how, experience, professionalism,
and ethical values to assist our partners in developing
drugs in compliance with laws and regulations, and
quickly. Our strength lies in the passion for what we do
and in the quality with which we do it. We believe that
clinical studies, particularly those incorporating scientific
and methodological innovation, can significantly contrib-
ute to medical progress and a better quality of life.
opis

Our core business


OPIS provides clinical research services and drug de-
velopment consultancy to pharma, biotech, and medical
device clients.
From early phase clinical trials through proof of concept
and up to late phase and post-market research, projects
are executed in compliance with regulatory require-
ments, ICH-GCP E6 guidelines, and with therapeutic-
specific attention. Operational staff that include medical
writers, regulatory experts, project managers, and
monitors as well as data managers, biostatisticians, and
SAS programmers assist sponsors with full-service
study management of multi-country trials.
The clinical trial data handling solution Clinical.net is
fully FDA 21 CFR Part 11-compliant and modular in
design to digitally manage EDC, protocol deviations,
patient randomisation, safety reporting, and study drug
handling.

Study types
·· Early phase trials
·· Phase II and III studies
·· Post-market studies
·· Observational research
·· Real World Evidence studies
·· Investigator Initiated Trials
·· Medical Device Clinical Investigations
·· Nutraceutical studies

Services
·· Medical Affairs and Medical Writing
·· Regulatory
·· Trial Start-Up
·· Data Management
·· Pharmacovigilance
·· Quality Assurance
·· e-Clinical Platform
·· Project Control
·· Statistical Analysis and Consultancy
·· Study Management and Monitoring
·· Preclinical and Drug Development Consultancy
·· Training

10th european biotechnology guide 2020 134 | 135


Name · PeproTech EC Company profile
PeproTech creates the building blocks of your life sci-
Address/P.O. Box · 29 Margravine Road ences research by manufacturing high-quality products.
Postal Code/City · W6 8LL London Since 1988, we have grown into a global enterprise with
Country · United Kingdom state-of-the-art manufacturing facilities in the US, and
Contact Person · Gareth Bolitho offices around the world. With over 2,000 products,
Telephone · +44-20-7610-3062 PeproTech has developed and refined innovative proto-
Fax · +44-20-7610-3430 cols to ensure quality, reliability, and consistency.
Email Address · info@peprotech.co.uk
Internet Website · www.peprotech.com
Social Media · FL I Quality policy
Number of Employees · 125 (Worldwide), 30 (UK) PeproTech is committed to supplying our custom-
Founded (year) · 1988 (US), 1993 (UK) ers with the highest-quality products and services to
achieve customer satisfaction, as well as to ensure
Areas of Activity · l Cell culture compliance with the requirements of the quality man-
l Stem cell and cell line development agement system and its continuing improvement.
l Cell preparation
l Fermentation
l Antibody production Cytokines
l Process development ·· GMP – PeproTech ensures that all aspects of our
l Molecular biology quality management system – from management of
l Kit development raw materials and equipment to facilities maintenance
(environmental monitoring), manufacturing processes,
Biological Patents · Production and vector patents internal audits, and inspection processes – are in
compliance with GMPs and all applicable regulatory
External · Researchers from academia and and standards requirements. We perform extensive
Collaborations industry quality control testing to verify that PeproGMP ®
Cytokines meet rigorous standards for purity, iden-
Request for · PeproTech is keen to discuss with tity, safety, activity, and consistency.
Further Collaborations researchers, production scientists, and ·· Animal-Free Product Line – This product line is de-
kit developers their research projects signed to minimise potential risks that can arise from
and specific requirements. trace amounts of animal-derived adventitious agents.
These proteins maintain identical high biological
activity and purity to the corresponding proteins that
are produced using standard techniques.
·· RUO – Full-length and fully biologically active Re-
search Use Only cytokines are developed in-house
by our experienced protein scientists. The process
starts in our molecular biology labs with gene design
and expression, continues to cell banking, and on to
fermentation/cell culture, purification, QC testing, and
finally QA review and release.
PeproTech

Antibodies, ELISA Kits & Media


·· Polyclonal Antibodies – These are purified through
the isolation of specific polyclonal antibodies from
antiserum by antigen affinity chromatography, which
typically yields >95% pure specific antibodies.
·· Biotinylated Antibodies – Produced from the polyclo-
nal antibodies mentioned above, these products are
ideal for use in any analytical procedures that require
biotinylated antibodies.
·· Monoclonal Antibodies – PeproTech’s monoclonal
antibodies are raised against full-length recombinant
antigens and have been thoroughly screened for
performance in a variety of applications.
·· ELISA Development Kits – PeproTech’s ELISA Devel-
opment Kits contain the necessary key components
for the quantitative measurement of natural and/or
recombinant proteins in a sandwich ELISA format.
·· Media – We offer a comprehensive line of cell culture
media products, designed around our high-quality
recombinant growth factors and manufactured by
PeproTech in state-of-the-art cell culture laboratories.

BioGems
BioGems is a PeproTech brand supplementing the
PeproTech product offering with complimentary lines
of high-quality products.
·· Small Molecules – A select portfolio of high-purity
small molecules for life science research, with a spe-
cial emphasis on the field of stem cell research, in-
cluding reagents that target the ROCK, Hedgehog,
and WNT pathways.
·· Flow Cytometry Products – These Flow Cytometry
antibody and support products have been carefully
selected to ensure consistent and reliable results. In
addition, BioGems offers a complementary line of
SAFIRE functional antibodies that are carrier and
sodium azide free, with minimised endotoxin levels,
for in vivo and in vitro applications.
·· ELISA Kits (Pre-Coated) – These are a line of pre-
coated ELISA Kits that are “ready to use” and contain
all the components required for the quantitative
measurement of the target protein.

10th european biotechnology guide 2020 136 | 137


Name · Polpharma Biologics S.A. From Discovery through to commercial
Polpharma Biologics is a rapidly expanding biopharma-
Address/P.O. Box · Gdansk Science and Technology Park ceutical company dedicated to improving patients’ lives
Trzy Lipy 3 bld A by providing affordable, high-quality biologics.
Postal Code/City · 80-172 Gdańsk
Country · Poland We operate four state-of-the-art facilities across Europe,
Contact Person · Roland Hecht (Head BD CDMO Europe) located in Utrecht, Gdańsk, Warsaw, and Munich.
Telephone · +48-58-770-95-59
Email Address · roland.hecht@PolpharmaBiologics.com We use our considerable market knowledge to select
office@polpharmabiologics.com biosimilars and new biologic entities to develop a pipe-
Internet Website · www.polpharmabiologics.com line of commercially valuable targets – all of which are
Social Media · I available for out-licensing through flexible partnership
Number of Employees · +500 models.
Founded (year) · 2013
Type of Laboratory · State-of-the-art biopharmaceutical de- Our most recent global commercialisation deal with
velopment centre for process develop- Sandoz AG for a natalizumab biosimilar underlines our
ment and optimisation; production of commitment to collaboration and quality.
clinical trials materials as well as
commercial supply of DS and DP. Through the development of biosimilars, we have deep-
Areas of Activity · l Cell line development based on ened our expertise, insights and experience. We are well
proprietary CHOBC® platform positioned to efficiently and expertly support your entire
l Full analytical methods and process project at all stages of biopharmaceutical development.
development Our dedicated team will tailor unique, customised solu-
l Process optimisation, scale-up and tions that fit your needs, bringing your products to
characterisation market faster.
l GMP DS production out of mammalian
cell culture at up to 2,000L scale Our flexible approach, reliability and in-depth knowledge
l GMP DS production in microbial means we are suited for a wide range of collaborations,
systems at up to 500L scale from fee-for-service contract development and manu-
l DP formulation development facturing projects to more long-term partnerships. We
l F&F (vials, pre-filled syringes, care about your products, your experience with us and
lyophilisation) your success.
External · Polpharma Biologics has entered a
Collaborations global commercialization agreement
with Sandoz AG for a natalizumab bio- Your biopharmaceutical one-stop-shop
similar. Under this agreement, Polp- We offer a truly integrated biopharmaceutical one-stop-
harma Biologics will be responsible for shop, which encompasses all required services from cell
the research & development (including line development all the way to sterile fill & finish, there-
clinical development) and manufactur- by shortening your time to market, reducing managerial
ing and supply of the biosimilar complexity and eradicating risky handovers between
Request for · l Contract development and multiple service providers.
Further Collaborations manufacturing of biopharmaceuticals
lO  ut-licensing and co-development of Our proprietary CHOBC® expression platform enables
biosimilars and novel biological entities rapid generation of high-quality cell lines at the highest
Polpharma biologics

titres for both protein-based innovative molecules and


biosimilar products.

By applying cutting-edge analytical methods and power-


ful process optimisation techniques, we are able to fully
characterize your product and start tailoring process
development towards your targeted profile in order to
maximize final commercial production yield from the very
beginning.

We perform high-quality, GMP-compliant manufacturing


of drug substance for both clinical and commercial sup-
ply using either mammalian cell culture (fermentation
scale of up to 2,000L) or microbial expression systems
(fermentation scale of up to 350L). Our flexible approach
includes the exclusive use of disposable equipment,
ensuring your demand is met on time, to the highest
possible standard.

Global demand for biopharmaceuticals is growing. To


serve this, we have built commercial-scale GMP produc-
tion facility for drug substance manufacturing in Warsaw.
The facility will become operational in 2021 and will have
a total capacity of 10 x 2,000 L cell cultures for drug
substance production.

Expertise and experience you can rely on


Polpharma Biologics’ is led by a team with decades of
international experience and a proven track record in
biologics development, clinical and commercial produc-
tion, registration and commercialisation.

Our dedicated and skilled scientists and engineers pro-


vide invaluable expertise and insightful advice, and our
Project Management Team ensures complete transpar-
ency, providing you with access to all the information you
may require to drive your project forward on your terms.
Polpharma Biologics brings expertise and flexibility to
every project. Rely on us to partner with you and tailor
solutions that fit your needs, bringing your high-quality
biologics to market faster and improving patients’ lives.
We care.

10th european biotechnology guide 2020 138 | 139


Name · ProBioGen AG Intelligent biopharmaceutical solutions
Internationally renowned specialist for developing and
Address/P.O. Box · Herbert-Bayer-Str. 8 manufacturing complex therapeutic glyco-proteins;
Postal Code/City · 13086 Berlin state-of-the-art service packages plus innovative plat-
Country · Germany form technologies. Manufacturing authorisation for
Contact Person · Dr Wieland Wolf (CEO) human biopharmaceuticals and operating to quality
Telephone · +49-30-322-935-100 standards of the EMA and FDA.
Fax · +49-30-322-935-400
Emails · info@probiogen.de Experience & client feedback
cmo@probiogen.de Over 25 years a successful development partner for leading
Website · www.probiogen.de biotechs & pharmas on novel products, biosimilars, and
Social Media · FIQ biobetters, e.g. Fc-fusion proteins, clotting factors, en-
Number of Employees · 160 zymes, or others. Clients value our scientific expertise, ex-
Founded (year) · 1994 cellent working relationships, and outstanding flexibility.
Type of Laboratory · S1, S2
Areas of Activity · |B  iopharmaceutical development and Services
GMP Production Facility Quality development services
|B  iopharmaceutical contract Offer as true “one-stop-shop” complete service packages
development and manufacturing from early lead optimisation, rapid and integrated develop-
| T echnologies for improving product ment of high-producer cell lines, processes and analytical
characteristics and process methods, up to full GMP manufacturing programmes.
efficiency Comprehensive analytics portfolio, incl. standard in-
process & release tests, and in vitro bioactivity assays.
Biological Patents · ProBioGen holds numerous Innovative technology platforms to optimise yields, boost
international patents on technologies product potency, increase development speed, or cut
to improve product quality/potency manufacturing costs; all independently licensable.
and enhance cellular productivity.
Integrated cell line and process development
External · With many international companies Pharmaceutical cell line development platform based
Collaborations and research organisations, e.g. LTC, on proprietary, royalty-free expression vector technol-
Boehringer-Ingelheim, Max-Planck- ogy, various pre-selected CHO host cells, and own
Institutes, etc. chemically defined media platform. Excellent reputation
of cell line development skills based on fine-tuned, in-
Request for · ProBioGen works with biotech and dividually adjusted clone selection procedures and
Further Collaborations pharma companies developing early integration of upstream and downstream selection
complex therapeutic glycoproteins or parameters. This allows selecting the optimal expres-
viral vaccines. Services include cell sion strategy for each protein and enables rapid, eco-
line and process development, up to nomic upstream process development.
GMP-manufacturing, based on animal
or human cell lines. In addition, Reliable and flexible contract manufacturing
proprietary product/process-improving Offers GMP production in fully state-of-the art dispos-
technologies are out-licensed. able systems in fed-batch and continuous processes in
up to 1,000 L bioreactors, incl:
·· Downstream Process Development
Probiogen

·· Cell Banking (MCB/WCB)


We
Wemake
makeour
ourexperience
experienceyours.
yours. ·· GMP Manufacturing
·· Analytical Development

Cell-based activity assays


An range of cell-based activity assays for potency and
mode-of-action analyses is established.

Technologies
GlymaxX® ADCC Enhancement
Glyco-engineering technology preventing cellular fucose
synthesis and thus antibody fucosylation for maximised
ADCC cell-killing activity against tumour and infected
cells. Works for novel and existing producer cell lines,
external expression platforms, or can be licensed alone.

Glyco-engineering
Fucose, galactose, and sialic acid levels of glyco-pro-
teins can each be adjusted, e.g. in biosimilar projects.

Transposase technology for superior titres


Novel, proprietary, epigenetic-guided transposase tech-
nology for transgene insertions into highly active genomic
regions; available for licensing or service projects.

Productivity-boosting pathway modulator


Stable introduction of an engineered cdc42 enzyme
typically increases cellular productivity 2-fold. Applica-
ble to existing cell lines and expression platforms, inde-
pendently licensable.

Human artificial lymph node: immunofunction


Fully human mini-bioreactor technology to test long-
term drug effects on the immune system in vitro. Unique
3D-matrix-assisted system uses primary cells to mimic
immune reactivity in vivo, to analyse immunogenicity,
immune-modulation, and -toxicity.

AGE1.CR® viral vaccine manufacturing platform


AGE1.CR® duck cell line replaces primary chicken fibro-
blasts for GMP-compliant viral vaccine production, incl.
highly attenuated ones, e.g. MVA and viral vectors.
Chemically defined media platform and scalable suspen-
sion processes for industrial production.

10th european biotechnology guide 2020 140 | 141


Name · Recipharm Recipharm is a leading contract development and
manufacturing organisation (CDMO) headquartered in
Address/P.O. Box · Box 603 Stockholm, Sweden. We operate development and
Postal Code/City · 10132 Stockholm manufacturing facilities in France, Germany, India, Is-
Country · Sweden rael, Italy, Portugal, Spain, Sweden, the UK, and the US,
Telephone · +46-8-602-52-00 and are continuing to grow and expand our offerings for
Email · info@recipharm.com our customers.
Website · www.recipharm.com
Social Media · I Employing around 7,000 people, we are focused on
Number of Employees · 7,000 supporting pharmaceutical companies with our full
Founded (year) · 1995 service, taking products from early development through
to commercial production. For over 20 years we have
Areas of Activity · l Drug substance development been there for our clients throughout the entire product
l Drug product development lifecycle, providing pharmaceutical expertise and man-
l Analytical chemistry aging complexity, time and time again.
l Clinical trial material
l Contract manufacturing for clinical Despite our growing global footprint, we conduct our
trial material and commercial supply business as we always have and continue to deliver
value for money with each customer’s needs firmly at
the heart of all that we do.

We provide support to pharmaceutical companies of all


sizes with their outsourcing requirements, with our com-
pany operating in two core areas.

Contract development services


Our development & technology segment offers clients a
comprehensive range of services, with the aim of sup-
porting the customer from the initial product concept to
the approved pharmaceutical drug, in some cases,
through various forms of risk sharing. We can offer both
experience and expertise in various services including:
·· Medicinal chemistry
·· Custom synthesis
·· Radiochemistry
·· ADC and bioconjugates
·· Drug product development
·· Recipharm Pathway to Clinic®
·· Extractables & leachables testing
·· Impurity identification
·· Stability studies
·· Inhalation development
European ·· Tablet formulation
Member of Biotechnology ·· Clinical supply
NET WORK
Recipharm

·· Project management
·· Regulatory support

Contract manufacturing services


Recipharm’s largest business stream is manufacturing
services. Our pharmaceutical manufacturing expertise
means we can deliver a large number of pharmaceuticals
in a variety of dosage forms requiring the use of a broad
range of technologies, including:
·· Solids
·· Semi-solids
·· Liquids
·· Inhalation
·· Injectables
·· Ophthalmics

As part of our manufacturing services, we also provide


our customers with a comprehensive packaging service
in a large number of variants.

We also help our customers by simplifying their proc-


esses and managing complexities. We do this by offering
additional services such as quality assurance, regula-
tory services, and logistics solutions, including Vendor
Managed Inventory (VMI).

For many of our clients that utilise our manufacturing


capabilities, it is important that we have a solid founda-
tion in drug development. We are proud to possess a
broad pharmaceutical expertise that is essential in de-
veloping and supplying drug products.

Within this business area, there is also a portfolio of


product rights, which forms the basis of distribution
through external partners.

Through an integrated knowledge exchange between


Recipharm’s manufacturing and development units, the
skills and experience we have are used to improve the
development organisation. Furthermore, this operating
model helps to achieve a degree of efficiency and en-
sures quality when a pharmaceutical drug transitions
from the development phase through to the manufactur-
ing phase. That’s the Recipharm way.

10th european biotechnology guide 2020 142 | 143


Name · Redx Pharma Plc About Redx Pharma Plc
Redx Pharma Plc is an exciting UK-based biotech focused
Address/P.O. Box · Block 33F Mereside on developing novel precision medicines that have the
Alderley Park potential to transform treatment in oncology and fibrosis.
Postal Code/City · SK10 4TG Macclesfield Redx uses its proven drug discovery expertise to generate
Country · United Kingdom development candidates that it will take into early clinical
Contact Person · James Mead (CFO) trials to drive future partnering and licensing opportuni-
Telephone · +44-1625-469909 ties. Our main programmes include:
Email Address · j.mead@redxpharma.com
Internet Website · www.redxpharma.com
Social Media · I Oncology: RXC004 (Porcupine inhibitor)
Number of Employees · 52 – Phase 1/2 Clinical Trial ongoing
Founded (year) · 2010 Porcupine is a key enzyme in the Wnt signalling pathway.
Type of Laboratory · l Drug discovery Aberrant Wnt signalling contributes directly to tumour
l Medicinal chemistry growth and plays a key role in immune resistance to treat-
l Pharmacology ment with immuno-oncology agents such as checkpoint
l DMPK inhibitors.

Areas of Activity · l Oncology RXC004 is a potent, selective, and orally bioavailable in-
l Immuno-oncology hibitor of the enzyme Porcupine and the ligand-dependent
l Fibrosis Wnt signalling pathway and has the potential to be used in
immuno-oncology treatment paradigms as monotherapy
External · l Jazz Pharma or as a combination partnering asset with immuno-
Collaborations (pan-RAF inhibitor programme) oncology agents such as anti-PD-1 checkpoint inhibitors.
Additionally, RXC004 has potential as a biomarker-guided,
Request for · Small molecule precision medicines targeted therapy in genetically defined cancers, such as
Further Collaborations with potential immuno-oncology or colorectal, pancreatic, and biliary cancers.
anti-fibrotic activity
The first-in-human clinical phase 1 trial of RXC004 aims to
evaluate the safety and tolerability of RXC004 in patients
with advanced malignancies (ClinicalTrials.gov Identifier:
NCT03447470). In the ongoing trial, we will establish the
optimal dose of RXC004 to use going forward, followed by
investigating the combination of RXC004 with anti-PD-1/
PD-L1 checkpoint inhibitors.

Fibrosis: RXC007 (Selective ROCK2


Inhibitor) – Clinical Trial starts 2021
ROCK2 (Rho Associated Coiled-Coil Containing Protein
Kinase 2) is an intracellular kinase with multiple cellular
functions. ROCK2 signalling plays a key role both in the
European inflammatory component and in the tissue re-modelling
Member of Biotechnology that drives disease progression in many fibrotic condi-
NET WORK
redx pharma

tions. ROCK2 expression and activity have been shown


to be upregulated in acute inflammatory injury and in
chronic diseases such as diabetes, metabolic syndrome,
and idiopathic pulmonary fibrosis (IPF). Furthermore,
ROCK2 activity is also upregulated in liver, lung, and
kidney models of fibrosis. Selective inhibition of ROCK2
prevents the hypotensive side effects typically associated
with systemic pan-ROCK inhibitors (dual ROCK1 and
ROCK2 inhibition).

In H1 2020, we nominated RXC007, a novel, orally active


ROCK2 inhibitor, as our next drug development candidate
in fibrosis, to be developed as a best-in-class treatment
with potential to address multiple diseases with underlying
fibrosis, including IPF, NASH, and diabetic nephropathy.
We aim to initiate a phase 1 study with RXC007 in H1 2021,
whilst evaluating clinical development pathways in IPF and
potentially in other disease areas.

Fibrosis: RXC006 (Porcupine Inhibitor)


– Clinical Trial starts 2021
Another area where Porcupine’s activity in the Wnt sig-
nalling pathway is relevant is in fibrosis. Aberrant Wnt
signalling is involved in fibrogenesis, and inhibition of Wnt
signalling is likely to prevent several mechanisms impor-
tant for fibrotic disease progression. Recent publications
have shown that Porcupine inhibitors are effective in
preclinical models and could be beneficial in the treat-
ment of fibrotic indications, including renal, heart, lung,
and skin conditions.

Our scientists have demonstrated that RXC006 potently


inhibits Porcupine, resulting in striking anti-fibrotic effects
in animal models of kidney, liver, and lung fibrosis. RXC006
has been nominated as a drug development candidate in
IPF, and IND-enabling studies have been initiated, with
first-in-human clinical trials expected to begin in 2021.
RXC006 is from a different chemical series to our lead
oncology asset RXC004 and is protected by a separate
composition of matter patent.

10th european biotechnology guide 2020 144 | 145


Name · Rentschler Biopharma SE A world-class biopharmaceutical CDMO
Rentschler Biopharma is a leading contract develop-
Address/P.O. Box · Erwin-Rentschler-Str. 21 ment and manufacturing organisation (CDMO), focused
Postal Code/City · 88471 Laupheim exclusively on client projects. From its headquarters in
Country · Germany Laupheim, Germany, and its site in Milford, MA, USA,
Contact Person · Dr Cora Kaiser (Senior Director Rentschler Biopharma offers process development and
Corporate Communication) manufacturing of biopharmaceuticals. The company’s
Telephone · +49 7392 701-0 high quality is proven by its long-standing experience
Fax · +49 7392 701-300 and excellence as a solution partner for its clients.
Email Address · communications@ Rentschler Biopharma is a family-owned company with
rentschler-biopharma.com about 1,000 employees.
Internet Website · www.rentschler-biopharma.com
Social Media · FIQ
Number of Employees · 1,000 Your trusted partner
Founded (year) · 1927 from concept to market
Type of Laboratory · S1 Rentschler Biopharma’s end-to-end offering includes
biopharmaceutical process development and manufac-
Areas of Activity · l Contract development and turing as well as related consulting activities. Rentschler
manufacturing organization (CDMO) Biopharma also provides project management and
for biopharmaceuticals regulatory support. With a focus on mammalian cell
l Focus on mammalian cell culture lines, Rentschler Biopharma is highly experienced in
the development and cGMP manufacturing of mono-
External · Strategic Alliance with LEUKOCARE AG, clonal antibodies, fusion proteins, and other therapeutic
Collaborations located in Munich, Germany, for best- proteins in compliance with international standards
in-class formulations (EMA/FDA).

Request for · Rentschler Biopharma offers Working collaboratively with its clients, Rentschler
Further Collaborations bioprocess development and cGMP Biopharma provides customised solutions with opti-
manufacturing solutions from concept mised work packages for each development stage.
to market for pharma and biotech State-of-the-art cGMP facilities and cell culture process-
companies in long-term collaborations es allow manufacturing for both, clinical studies and com-
and strategic partnership settings. mercial supply. Ongoing monitoring of the international
regulatory landscape and in-depth understanding of the
necessary regulatory documentation (CMC) ensures that
each project is properly documented in accordance with
regulatory requirements.

In order to offer best-in-class formulation development


along the biopharmaceutical value chain, the company has
entered into a strategic alliance with LEUKOCARE AG.
Rentschler biopharma

Bioprocess development
·· State-of-the-art cell line development
·· Fast and efficient supply for multiple candidate
screening
·· Robust and scalable CHO cell lines for cGMP manu-
facturing
·· Efficient cell culture and purification processes
·· Well-established analytical methods
·· Advanced formulation development exclusively by
LEUKOCARE AG

Best-in-class formulation development


Rentschler Biopharma’s strategic alliance with LEUKOCARE
offers best-in-class formulation development considered
at every step of the biopharmaceutical development and
manufacturing process. The rational and tailored process
applies a maximum design space, including LEUKOCARE‘s
proprietary Stabilising and Protecting Solutions (SPS®),
resulting in products with superior formulations and
administration routes. This comprehensive database-
driven approach and algorithm-based formulation selec-
tion provide clients significant competitive advantages,
enabling them to exploit the full commercial potential of
their products.

cGMP biomanufacturing
·· Multiple stainless steel bioreactor lines, including a
twin system with 2x 3,000 L
·· Flexible single-use bioreactor lines up to 2,000 L
·· State-of-the-art purification processes
·· Guaranteed product quality and purity in accordance
with cGMP guidelines

10th european biotechnology guide 2020 146 | 147


Name · RheinCell Therapeutics GmbH The field of cell therapy is one of the most promising
developments in modern medicine. But autologous ap-
Address/P.O. Box · Berghausener Straße 98 proaches – based on cells made patient-by-patient – are
Postal Code/City · 40764 Langenfeld extremely expensive and time-consuming and thus, un-
Country · Germany suited for routine applications. Instead, regenerative cell
Contact Person · Jürgen Weißer therapy requires allogenic off-the-shelf therapeutics.
Telephone · +49-2173-32820
Fax · +49-2173-3282015 RheinCell Therapeutics GmbH specialises in the GMP-
Email Address · contact@rheincell.de compliant generation of human-induced pluripotent
Internet Website · www.rheincell.de stem cells (iPSC) from HLA-homozygous allogeneic
Social Media · I umbilical cord blood (CB).
Number of Employees · 18
Founded (year) · 2017 Our main focus is on setting up an iPS cell library con-
sisting of various HLA-homozygous iPS master cell
Areas of Activity · l iPSC banks. The key idea behind this is that only a limited
l Cell therapy number of iPSC lines are needed to set up an allogenic
resource which prevents immune rejections in a large
number of recipient patients. Thus, this master cell
library serves as an “off the shelf” platform for various
types of cell therapeutics and has the potential to be-
come the starting material of any future iPSC-based cell
therapy in the western world – and beyound.
rheincell therapeutics

Our expertise covers the entire spectrum of the medi-


cally oriented iPSC workflow and is based on our long-
standing expertise in human iPSC technology. This
includes cellular reprogramming under GMP conditions,
GMP/ATMP-grade iPSC expansion and cryopreser-
vation, targeted genetic manipulation (optional), and
directed differentiation.

Our interdisciplinary team of scientists and engineers is


composed of experts in the areas of iPSC technology,
stem cell differentiation, cell banking, medicine, GMP
production, and regulatory affairs. RheinCell scientists
have outstanding expertise in cellular reprogramming
and R&D of stem cells at an international level.

10th european biotechnology guide 2020 148 | 149


Name · Richter-Helm BioLogics GmbH & Co. KG German reliability and thoroughness
Richter-Helm is a Hamburg, Germany-based contract
Address/P.O. Box · Suhrenkamp 59 manufacturing company specialised in GMP-compliant
Postal Code/City · 22335 Hamburg microbial production, with a proven 30-year track
Country · Germany record. Clients worldwide have already benefited from
Contact Person · Dr Antje Weingarth our commitment to good manufacturing practice and
Telephone · +49-40-55290-436 total transparency. Our work focuses on recombinant
Fax · +49-40-55290-888 proteins, plasmid DNA, antibody fragments, and vac-
Email Address · a.weingarth@richter-helm-biologics.eu cines with a strong focus on the supply of material for
Internet Website · www.richter-helm.eu late clinical studies and commercial demand.
Number of Employees · ~240
Founded (year) · 1987 Count on us to provide a comprehensive range of
services and customised solutions. Our seasoned,
Areas of Activity · Contract development and 240-strong team supports you with process develop-
manufacturing of biopharmaceuticals ment, supply of products for clinical trials, and com-
derived from microbial systems mercial production. We operate two GMP-compliant
production plants with bioreactor capacities of up to
Biological Patents · Several patents on manufacture of 1,500 litres, enabling GMP manufacturing for phase I to
recombinant proteins III up to commercial supply. Our large equipment fleet
and extensive experience with many product types en-
External · Richter-Helm is working with Biotech able us to very flexibly meet your needs.
Collaborations and Pharma companies worldwide
As a biopharmaceutical manufacturer we are keenly
Request for · Richter-Helm’s Business Development aware of our responsibility towards patients. To meet
Further Collaborations team will be pleased to learn more the high quality requirements, Richter-Helm consistently
about your needs for development works to the highest standards of pharmaceutical qual-
and GMP manufacturing services to ity. This has been verified by major regulatory bodies
bring your project one step further. including EMA, FDA, ANVISA, PMDA, and MFDS, as
well as by numerous customer audits.
For more detailed information please
contact us.
Richter-helm

Products and services


The highly motivated and experienced teams at Richter-
Helm have excellent expertise in development and
GMP-compliant production of biopharmaceuticals. To
ensure efficient and transparent work, we apply pro-
fessional project management methods. Our process
development team possesses extensive experience in
developing and optimising fermentation and purifica-
tion processes. For initial strain development, a variety
of proprietary E. coli expression systems is available to
support strain selection. Small scale models of existing
processes provide helpful tools for trouble shooting,
process characterisation, and validation. Furthermore,
small scale models also ensure a smooth scale-up to
large-scale GMP-compliant manufacture.

The quality system at Richter-Helm meets the strictest


standards of quality in biopharmaceutical production.
Our in-house QC testing covers development and vali-
dation of a variety of analytical methods (incl. biological
assays), performance of stability studies, and charac-
terisation of reference standards.

Richter-Helm offers a full range of biopharmaceutical


manufacturing services, including:
·· Establishment of cell banks (MCB/WCB)
·· GMP manufacturing for phase I to III
·· Commercial GMP manufacturing

Thanks to the broad knowledge of Richter-Helm’s


experts and many years of experience gained from
different kinds of projects, Richter-Helm works out
tailor-made solutions for its worldwide customers,
which include large pharmaceutical companies as well
as advanced biotech companies. We treat each of our
customers’ projects individually and with the highest
flexibility – guaranteeing a successful partnership.

10th european biotechnology guide 2020 150 | 151


Doing now what patients need next

Name · Roche Diagnostics GmbH Company profile


Penzberg is the Bavarian location of Roche Diagnostics
Address/P.O. Box · Nonnenwald 2 GmbH. Situated south of Munich on 434,000m2, and
Postal Code/City · 82377 Penzberg with a workforce of around 6,400 employees, it is one
Country · Germany of Europe’s largest biotech centres for research, devel-
Contact Person · Dr Johannes Ritter opment and the production of active pharmaceutical
Telephone · +49-8856-60-2600 ingredients and diagnostics. With more than 45 years
Fax · +49-8856-60-3417 of experience, this site is a pioneer in the industrial scale
Email · penzberg.allgemein@roche.com of the biotechnology discipline. At the same time, Roche
Website · www.roche.de at Penzberg is the largest employer with significant
Number of Employees · 6,400 economic impact in the region. Roche continues to
Founded (year) · 1896 (Group) expand the biotechnology competence in Penzberg.
Type of Laboratory · S1–3 This is how the site has been strongly expanded over
the past five years. Investments focused on production
Areas of Activity · Biotechnology based research, capacities for active pharmaceutical ingredients, diag-
development, production of nostics and overall infrastructure. This well exceeds a
diagnostics and raw materials total of €1.3bn in the last five years that Roche has in-
(including Custom Biotechs), vested in the Greater Munich biotechnology.
active pharmaceutical ingredients
Personalised Healthcare
Annual Turnover · CHF 61.5 bn (Group) The Penzberg Biotech Center is the only Roche location
Relevant R&D Budget · CHF 11.7 bn (Group) in the world that performs research, development and
production for both Roche Divisions: Diagnostics and
Request for · www.roche.com/partnering.htm Pharma. This results in extensive synergetic cross-net-
Further Collaborations working between the two divisions and thus Roche is
uniquely positioned to drive Personalised Healthcare
(PHC) forwards. PHC is about providing the right treat-
ment for the right group of patients. Roche’s strengths in
pharmaceuticals and diagnostics along with advances in
science and technology have made fitting treatments for
patients possible. Previously, only five out of ten patients,
on average, benefited from their treatment. Today, up to
80% of patients respond to their targeted therapies.

Targeted treatments are based on the molecular caus-


es of disease. That means treatments are based on the
presence of biomarkers and through companion diag-
nostic tests indicating mutations or genetic expressions
in the patients’ tissue. For example, in the past, non-
small cell lung cancer (NSCLC) was just diagnosed as
NSCLC. Today, over a dozen gene mutations are known
to play a role in this type of cancer. The detection of
biomarkers via diagnostic tests allows for a more tar-
geted treatment that patients can benefit from.
Roche Diagnostics

Diagnostics
For the Roche Professional Diagnostics business unit,
Penzberg performs research, development and produc-
tion of systems reagents and control sera for automated
analysers in a professional lab environment or hospital
related use. Growth drivers are immunological tests, the
development of new biomarker tests and enzymatic
clinical chemistry tests. Examples are thyroid parame-
ters, lipid analysis, glucose metabolism, osteoporosis
markers, cardiovascular diseases, women’s health and
fertility, infectious diseases and tumour markers. All
components of the immunological tests and control sera
are manufactured on site. Operations in Penzberg there-
fore produce over 1,800 different raw materials for all
Diagnostics business units. It is safe to say that nearly
all Roche Diagnostics tests contain components from
Roche Penzberg. Furthermore, Roche is a renowned
partner for custom biotech solutions in various fields.

Pharma
The Greater Munich site also stands for units of Pharma
Research and Early Development. The Roche Innovation
Center Munich focuses on therapeutic proteins, includ-
ing next generation monoclonal antibodies. The portfo-
lio comprises Roche’s five major focus areas: oncology,
immunology, infectious diseases, ophthalmology and
neuroscience. Biological and preclinical research for
immuno oncology, biomarkers, the identification of tis-
sue markers and histopathology are also located here,
as is the management of clinical studies up to phase II.

The department Technical Development Europe is at the


cutting edge in the manufacturing processes of drug sub-
stance, parenteral drug product and devices for clinical
trials and brings therapies from clinical phase I into the
market. As an important link between pharmaceuticals
research and commercial, the core business of this unit is
the development and optimisation of manufacturing proc-
esses, formulations, devices, analytics and packaging.
And finally, Roche at Penzberg in the Greater Munich area
is a large scale biotechnological production facility of
active pharmaceutical ingredients (API), including mono-
clonal antibodies. Therapeutic APIs made in Penzberg
target disease areas like cancer, anemia and hepatitis.

10th european biotechnology guide 2020 152 | 153


Name · Rotoinox d.o.o. Innovative solutions for the biggest
challenges in the process industry
Address/P.O. Box · Prvomajska ulica 39 Over the last four decades Rotoinox has designed,
Postal Code/City · 5000 Nova Gorica manufactured, and commissioned innovative solutions
Country · Slovenia for the largest pharmaceutical companies worldwide,
Contact Person · Mr Blaz Pavsic and has set standards in the industry on every level.
Telephone · +386-5-330-63-55 What makes the company outstanding are its high
Fax · +386-5-330-63-56 quality and pioneering solutions, a genuine passion for
Email Address · blaz.pavsic@rotoinox.com the work, and a commitment to a reliable partnerships
Internet Website · www.rotoinox.com that put people and relationships first.
Social Media · I
Number of Employees · 34 Rotoinox works with the most renowned biotechnology,
Founded (year) · 1979 chemical, and pharmaceutical companies on everything
from preclinical development to commercial projects.
Areas of Activity · Engineering, manufacturing, and
assembling systems and equipment for
pharmaceutical, chemical, and Dedicated to providing the highest
biotechnology companies. quality products and services
Core products: With its deep understanding of specific processes,
l Bioreactors engineering and manufacturing know-how, and a long
l Fermentors track record of expertise in the field, Rotoinox offers a
l Process vessels wide range of services and products.
l Process systems
l CIP/SIP units
Services
External · Collaborations with pharmaceutical, ·· Consulting (best technical solutions, audits, quality
Collaborations chemical, and biotechnological control)
companies, process engineering ·· Design (concept, basic, detail)
companies, and universities. ·· Process Engineering
·· Customised Process Systems
Request for · Our business development team is ·· Realisation and Construction
Further Collaborations happy to discuss your project and find ·· Qualification and Validation
tailor-made solutions for your
challenges.
Core products
Please do not hesitate to contact us at ·· Bioreactors
info@rotoinox.com. ·· Fermentors
·· Process vessels
·· Process systems
·· CIP/SIP units
rotoinox

Quality statement
Rotoinox has been ISO 9001 certified since 2005,
demonstrating its commitment to consistently providing
high-quality products and innovative services that meet
the needs and expectations of its clients.

All facilities, equipment, and critical materials are under


control and are cGMP and ASME BPE-compliant. Other
key quality certificates include the Quality Welding
Management System certified according to EN 3834-2
and manufacturing pressure equipment according
to the Pressure Equipment Directive 2014/68/EU and
AD 2000.

Leading experts in the field


The commitment the production and design of high-
quality and innovative solutions can only be achieved
with the support of experts. That’s why Rotoinox employs
only the best-qualified and most competent individuals
in the field.

Over the last four decades the company has designed,


manufactured, and commissioned many highly ambi-
tious European projects, setting industry standards at
every level.

10th european biotechnology guide 2020 154 | 155


Name · Rottapharm Biotech Experienced with Innovation
Rottapharm Biotech is a large biotech based in Italy, in
Address/P.O. Box · Via Valosa di Sopra, 9 Monza the Monza – Milano area. Born as a research-and-
Postal Code/City · 20900 technology-driven company, Rottapharm Biotech
Country · Italy consists of about 100 scientists dedicated to drug dis-
Contact Person · Lucio Rovati, MD covery and development, with all R&D assets and fa-
Telephone · +39-039-9066-104 cilities (>4,000 m2 laboratories). As the spin-off of the
Fax · +39-039-9066-161 entire R&D operations of the former Rottapharm|Madaus,
Email Address · lucio.rovati@rottapharmbiotech.com it has a track record of 19 marketed proprietary products
Internet Website · www.rottapharmbiotech.com (described in >1,000 peer-reviewed publications), over
Number of Employees · 100 80 patent families, and ca. 600 single patents.
Founded (year) · 2014

Areas of Activity · Drug discovery and development Expertise


(new target validation, development of Rottapharm Biotech operates with a mixed discovery
animal models, pharmacological and model of new chemical entities (small molecules) and
pharmacokinetic characterisation of biologics obtained using a proprietary technology for
new drug candidates, original the generation and selection of therapeutic monoclonal
formulation, design of innovative antibodies against innovative targets.
clinical trials) of small molecules and
biologics in the following therapeutic The R&D expertise covers rheumatology (osteoarthritis
areas: rheumatology (osteoarthritis and rheumatoid arthritis), pain and inflammation, im-
and rheumatoid arthritis), pain and munomodulation and immuno-oncology, selected on-
inflammation, immunomodulation and cology areas, and the central nervous system. Expertise
immuno-oncology, selected oncology includes new target validation, development of animal
areas, and the central nervous system. models, pharmacological and pharmacokinetic char-
acterisation of new drug candidates, original formula-
tion, and design of innovative clinical trials.

Business model
Rottapharm Biotech’s business model consists of a
flexible approach, where drug development is carried
out mainly on internal proprietary discoveries, but also
on external projects deriving from early-stage in-licens-
ing or other forms of collaboration. Opportunities for
out-licensing are considered during any development
phase, but are pursued systematically once the clinical
proof of concept has been achieved.
Rottapharm biotech

Projects
CR6086 is a novel immunomodulator acting as an an-
tagonist at the PGE2 receptor EP4 subtype. CR6086 is
in Phase II clinical development as a DMARD for rheu-
matoid arthritis.
Immuno-oncology has emerged as an additional thera-
peutic area for CR6086. The PGE2-EP4 axis plays a
major immunosuppressive role in the tumour microen-
vironment, favouring cancer progression. An important
application is the combination of CR6086 with immune
checkpoint inhibitors in patients who have advanced
cancer and/or inadequate response to anti-PD-1/PD-L1
therapy in selected indications (e.g. microsatellite stable
colorectal cancer).

CR4056 is a first-in-class imidazoline-2 (I2) receptor


ligand with potent analgesic activity in a broad spectrum
of animal pain models. I2 ligands facilitate the noradren-
ergic inhibitor y pain pathways with an innovative
mechanism, and have a marked opioid-sparing activity
(synergism with opioids, delay/reversal of tolerance,
decreased opioid-induced adverse effects and abuse
potential).
Clinical proof of concept for CR4056 as a non-opioid
analgesic has been obtained in chronic pain associated
with osteoarthritis. Potential therapeutic indications span
from nociceptive to neuropathic chronic pain and use as
an opioid-sparing drug in multimodal analgesia.

CR13626 is a novel potent inhibitor of tyrosine kinases


relevant to glioblastoma. CR13626 efficiently crosses
the blood-brain barrier and is not a substrate of multid-
rug efflux transporters.
CR13626 decreases the proliferation of different human
glioblastoma cell lines and reduces tumour growth,
eventually prolonging survival, in mouse models of
glioblastoma.

Osteoarthritis (OA) discovery pipeline. OA is a hetero-


geneous disease: patients belong to different disease
phenotypes. The investigation of OA phenotypes (with
a focus on metabolic and inflammatory phenotypes) is
the approach we are following at Rottapharm Biotech.

10th european biotechnology guide 2020 156 | 157


Name · Socorex Isba SA Your partner in precision volumetry
Socorex Isba SA is a Swiss manufacturer of highly reli-
Address/P.O. Box ·
Chemin de Champ-Colomb 7a able laboratory instruments used for measuring, dosing,
Postal Code/City ·
1024 Ecublens transferring, dispensing, and injecting liquids in a large
Country ·
Switzerland number of applications.
Contact Person ·
Yves Lachavanne Manual and electronic micropipettes, single and multi-
(Marketing & Sales Support Manager) channel pipettors, repeater pipettes, dispensers, pi-
Telephone · +41-21-651-6000 pette controllers, and re-usable syringes, together with
Email Address · socorex@socorex.com pipette tips, consumables, and accessories, constitute
Internet Website · www.socorex.com the heart of the programme.
Social Media · FL I  The company is committed to manufacturing the most
Number of Employees · 55 reliable products and to offering the best services.
Founded (year) · 1963 “A to Z” Quality Management includes quality checks
and individual instrument performance control in the
Areas of Activity · Liquid handling instruments metrology laboratory, attested by an individual ISO 8655
certificate.
Warranty coverage is three years on all manual pipet-
tors and two years on electronic pipettes, dispensers,
and repeaters.

The efficient service centre offers a global maintenance


programme in its Ecublens-accredited laboratories.
The selection ranges from basic checks to ISO 17025
accredited calibrations of all micropipettes and dispens-
ers – whatever their brand.

Selected amongs the best laboratory equipment sup-


pliers, an international network of distributors carries
a stock of products and provides technical support,
repairs, and calibration services.

Key products for biotech labs


Acura® manual micropipettes – exceptional ergonomics
The adequate shape of the finger rest maintains the
micropipette in position without hand stress. The ad-
justment button allows easy volume setting, even when
using a glove. Located at the front of the instrument, the
display window is visible at all times during pipetting.

The soft springs and tightness ring with PTFE sleeve


reduce friction and make plunger activation smoother
than ever. Ergonomically positioned, the large-surface,
soft-padded ejector button allows low-pressure activa-
Socorex Isba

tion. In addition, JustipTM shaft height adjustment system


allows a wide selection of tips to tightly fit the nozzle.

Qualitix® – pipette tip programme


Made from virgin polypropylene and free from DNAse,
RNAse, pyrogens/endotoxins, and ATP, the tips provide
for a very high purity degree. In addition, sterile tips are
certified free of human DNA.
Intended for accurate liquid delivery, the Qualitix® ideally
combines with the Socorex® and all major micropipette
brands.
The tipfill rack filling system enables easy rack loading.
Each insert is instantly transferred into an empty rack
without risk of contamination. Its simplicity of use makes
tipfill a convincing choice.
Handling of viscous liquids is facilitated when using
low-protein binding tips. Certified protease free, they
are well adapted in the proteomic field. Sterile tip users
now have the choice between models with and without
a protection filter.

Bottle-top dispensers – excellent chemical resistance


Intended for safe and reproducible liquid distribution, the
CalibrexTM dispenser line includes 7 different sizes: 0.1–1 /
0.25–2.5 / 0.5–5 / 1–10 / 2.5–25 / 5–50 / 10–100 mL.

·· CalibrexTM organo 525 suited for organics and non-


crystallising solutions.
·· CalibrexTM solutae 530 for trouble-free distribution of
salt solutions, weak and strong acids, and bases.

Volume setting with a spring-loaded sliding cursor, softly


moving up and down along the dual scale. Thanks to the
optional flow control stopcock for priming dispenser,
reagent is recycled without loss or contamination.
Valves, plunger, barrel, and delivery jet are removable
in seconds for cleaning. The printed QR code allows
instant access to the chemical resistance chart. Fully
autoclavable at 121°C.
Access to calibration mechanism is protected by a
safety seal sticker. The integrated key is located under
the plunger cap.

10th european biotechnology guide 2020 158 | 159


Name · Swiss Biotech Association The central resource for
the Swiss biotech industry
Address/P.O. Box · Stauffacherstrasse 16 The Swiss Biotech Association represents the interests
Postal Code/City · 8004 Zurich of the Swiss biotech industry. To support its members
Country · Switzerland in a competitive market, the Swiss Biotech Associa-
Telephone · +41-44-455-56-78 tion works to secure favourable framework conditions
Email Address · info@swissbiotech.org and facilitate access to talent, novel technologies, and
Internet Website · www.swissbiotech.org financial resources. To strengthen and promote the
Number of Employees · 2.5 (FTE) Swiss biotech industry, the Swiss Biotech Association
Founded (year) · 1998 collaborates with numerous partners and life science
clusters globally under the brand Swiss Biotech™.
Areas of Activity · National cluster development
powered by Swiss Biotech Association The association’s core objective is to ensure that the
value generated by the Swiss biotech industry con-
External · National and international tinues to grow and that the industry contributes to the
Collaborations stakeholders of the Swiss biotech well-being of the socio-economic ecosystem, thereby
industry enabling Switzerland to be a key player at the forefront
of bioscience innovation.

To this end, the Swiss Biotech Association is dedicated


to supporting Swiss biotech companies by:

Developing favourable and competitive framework


conditions
·· Creating awareness of the biotech industry’s needs
and interests with policy makers
·· Advocating a competitive tax system alongside lean
and pragmatic regulations
·· Fostering life science education, technology transfer,
and intellectual property

Attracting talent, know-how, and financial resources to


drive innovation and growth
·· Promoting and facilitating access to funding oppor-
tunities
·· Connecting investors and attractive biotech invest-
ment opportunities
·· Facilitating access to national and international talent
swiss biotech

United forces lead to the Fostering networking through strategic, national, and
summit – We offer many international partnerships
paths to success ·· Connecting industry stakeholders and life science
clusters
·· Organising and co-promoting national and interna-
Join the tional life science events
·· Providing access to privileged information through
Swiss Biotech Association industry platforms and working groups
swissbiotech.org
Promoting the accomplishments of the Swiss biotech
industry
·· Disseminating the value-creation of Swiss biotech
companies
·· Visualising the diversity and competitiveness of Swiss
biotech companies
·· Presenting innovative products and technologies and
their contribution to quality of life

Join the Swiss Biotech Association


As a Swiss Biotech Association member you profit from
our engagement with national and international stake-
holders, receive privileged information, share knowledge,
improve your network, and optimise business efficiency.
You also gain more visibility and receive discounts at
events, as well as favourable rates with business solution
providers and for promoting your company.

Become a member of the biotech community and apply


now for a membership at www.swissbiotech.org.

1 Nation 1 Biotech Cluster

10th european biotechnology guide 2020 160 | 161


ech-Ins-97x232-2020-V2.indd 1 27.01.20 21:02
Name · Taconic Biosciences GmbH Taconic Biosciences is a fully-licensed, global leader
in genetically engineered rodent models and services.
Address/P.O. Box · Marie-Curie-Strasse 10 Founded in 1952, Taconic provides the best animal
Postal Code/City · 51377 Leverkusen solutions so that customers can acquire, custom gen-
Country · Germany erate, breed, precondition, test, and distribute valuable
Contact Person · John DelliSanti research models worldwide. Specialists in genetically
Telephone · +45-70-23-04-05 engineered mouse and rat models, microbiome, im-
Fax · +45-69-80-35-99 muno-oncology mouse models, and integrated model
Email Address · info@taconic.com design and breeding services, Taconic operates three
service laboratories and six breeding facilities in the US
US Division: and Europe, maintains distributor relationships in Asia,
Name · Taconic Biosciences and has global shipping capabilities to provide animal
Address/P.O. Box · One Discovery Drive, Suite 304 models almost anywhere in the world.
Postal Code/City · Rensselaer, NY 121144
Contact Person · Kelly Owen Grover, MB Taconic’s main goal is always to provide our custom-
Telephone · +1-518-697-3900 ers with the best solution, and this begins with superior
Fax · +1-518-697-3905 products. From high-performance standard strains, to
Email Address · info@taconic.com exclusive best-in-class models, to the most compre-
hensive genetic and health quality programme, Taconic
Internet Website · www.taconic.com sets customers up for success. In addition to offering
Social Media · FL I  superior products, Taconic also has the most compre-
Number of Employees · 800 worldwide hensive gene modification toolkit in the industry. Offer-
Founded (year) · 1952 ing CRISPR gene editing, Easi-CRISPR, homologous
Type of Laboratory · S1 recombination gene targeting, shRNAi silence targeted
gene expression, pronuclear injection, and targeted
Areas of Activity · Taconic Biosciences is a fully-licensed, transgenesis, Taconic’s model generation team is able
global leader in genetically engineered to help customers find the right solution by being able to
rodent models and services leverage all relevant technologies, in combination with
20 years of experience.
taconic

Aerial view of Taconic’s Germantown facility Finally, Taconic is the only comprehensive and integrated
model design and breeding services provider, allowing
seamless planning and integration of model generation
and breeding projects. With PhD scientists manag-
ing and dedicated to each project from start to finish,
Taconic starts each breeding discussion with a clear
understanding of the customer’s goal and then creates
a custom breeding plan with defined milestones. From
the routine to the highly customised, Taconic’s quality
and dedication to help customers succeed is what has
made us an industry leader for over 60 years.

10th european biotechnology guide 2020 162 | 163


Name · Talk Biotech Ltd About us
With a combined experience of over 30 years in the Life
Address/P.O. Box · Birkdale House Sciences industry we thrive on putting you first with our
Postal Code/City · CW2 6NY Cheshire ethos of customer care, collaboration, and support,
Country · United Kingdom listening to fully understand your needs. We provide
Contact · Customer Care the most appropriate human biospecimens & biomarker
Telephone · +44-1270-749196 research services to help support your in-house teams
Email Address · customercare@talk-bio.com and advance your human health research strategies.
Internet Website · www.talk-bio.com
Social Media · FL I
Founded (year) · 2017 Personal hypoxia cell culture workstation
Regulating the oxygen environment using the partial
Areas of Activity · l Biomarker Assay Services pressure of oxygen (mmHg or kPa), our pioneering, sci-
l Image Analysis entifically rigorous approach eliminates errors due to at-
l Opti-OX mospheric pressure variations or geographical altitude
l iPSCs & sets the benchmark for the most accurate hypoxia
l Hypoxia Workstations workstation available. A fully humidified, temperature
l Human Biospecimens and CO2-controlled hypoxia environment is achieved
in less than 15 minutes from switch-on.

Biomarker imaging assay services


From autoimmune diseases to the Zika virus, we provide
assay development and optimisation, including partial
validation of nucleic acid and protein biomarker assays
for almost any human tissue sample type.

European
Member of Biotechnology
NET WORK
talk biotech

Digital pathology &


image analysis services
We provide image acquisition and analysis, from basic
H&E annotations and measurements to bespoke identi-
fication, localisation, quantification, and spatial analysis
algorithms for complex multimodality & multiplexed
biomarker studies including immuno-oncology, neurol-
ogy, and infectious disease panels.

We love to talk bio all day, but when we’re talking about
your important projects, we keep the talk focused and
with your end goal always in mind. We know you need
results, we know you need them quickly, and we’re here
to help!

10th european biotechnology guide 2020 164 | 165


Name · Technologiepark Heidelberg GmbH World-renowned life science site
Heidelberg Technology Park is one of Germany’s premier
Address/P.O. Box · Im Neuenheimer Feld 582 sites for innovative high-tech companies. Heidelberg
Postal Code/City · 69120 Heidelberg Technology Park offers flexible infrastructure for biotech-
Country · Germany nology, pharmaceuticals, digital health, medical technol-
Contact Person · Dr André H.R. Domin ogy, bioinformatics, organic electronics, environmental
Telephone · +49-6221-50257-00 technologies, and IT. Researchers, developers, and pro-
Fax · +49-6221-50257-11 ducers alike find fitting working conditions, an outstanding
Email Address · technologiepark@heidelberg.de network, and hands-on support for their activities.
Internet Website · www.technologiepark-heidelberg.de
Social Media · IL Strong partners at your side
Number of Employees · 12 Since 1984, Heidelberg Technology Park has been of-
Founded (year) · 1984 fering lab space, clean rooms, and offices to science
Type of Laboratory · S2 standard, GLP, and GMP labs and technology-driven companies. Today, more than
90 companies and over 2,800 employees share 85,000
Areas of Activity · l Biotechnology sqm across six locations. Tenants leverage the close
l Pharmaceuticals proximity to Heidelberg University, German Cancer
l Digital health Research Center (DKFZ), European Molecular Biology
l Medical technology Lab (EMBL), and twelve university hospitals with more
l Bioinformatics than one million patients per year.
l Organic electronics
l Environmental technologies Startup support office
l IT Heidelberg Technology Park operates an inter-institutional
External · l Association of University Research and inter-disciplinary startup support office. A dedicated
Collaborations Parks (AURP) team supports entrepreneurs in raising public funding,
l BIO Deutschland e.V. finding partners and investors, and starting a sustainable
l Biotechnology Innovation business. Various events like startup weekends, hacka-
Organisation (BIO) thons, fireside chats, talks, and seminars enable easy ac-
l BioRN Network e.V. cess to a thriving regional startup scene. The startup sup-
l Bundesverband Deutscher port office is also headquarters to the Heidelberg Startup
Innovations-, Technologie- und Partners network, a joint initiative including Heidelberg’s
Gründerzentren e.V. (BVIZ) leading research and educational institutes.
l Heidelberg Startup Partners e.V.
l International Association of Science Accelerator programmes
Parks and Areas of Innovation (IASP) Two accelerator programmes at Heidelberg Technology
Request for · l Biotechnology Park offer a fast lane for life science and IT startups: the
Further Collaborations l Pharmaceuticals Life Science Accelerator Baden-Wuerttemberg is an ex-
l Digital health clusive twelve-month programme consisting of a series
l Medical technology of seminars, workshops and mentoring by seasoned
l Bioinformatics entrepreneurs and market experts. The Up2B Accelera-
l Organic electronics tor for IT startups with a business-to-business focus
l Environmental technologies includes various programmes for business modelling,
l IT product development, and fundraising. Both accelerator
programmes are non-diluting and free of charge.
technologiepark
heidelberg

International network
Heidelberg Technology Park has been the root of BioRN,
the regional life science research and industry cluster.
Additional memberships include the Association of
University Research Parks (AURP), BIO Deutschland
e.V., Biotechnology Innovation Organisation (BIO), Bun-
desverband Deutscher Innovations-, Technologie- und
Gründerzentren e.V. (BVIZ), and the International Asso-
ciation of Science Parks and Areas of Innovation (IASP).
Active participation ensures optimal representation of
our tenants and members.

Space to grow
The newly built Business Development Center Heidel-
berg (BDC HD) offers 7,000 sqm of wet lab, cleanroom,
and office space. The new building is part of the up-
coming Heidelberg Innovation Park (HIP), Heidelberg’s
latest campus for collaborative research and eceonomic
development. The BDC HD offers specialised real estate
including branch-specific networks as well as commodi-
ties like a conference center and co-working spaces, the
AI Lab of the State of Baden-Wuerttemberg, and two
accelerator programmes.

Park – in brief
·· More than 85,000 sqm wet lab, cleanroom, and office
space for startups and growing companies
·· Startup support office and Heidelberg Startup Part-
ners network
·· Accelerator programmes for Life Science and IT / B2B
startups
·· Business development support
·· Entrée to an international network
·· Central location
·· Flexible infrastructure
·· Kindergarten
·· Conference Center
·· Bistro/Canteen
·· Car and eBike Sharing station
·· International PartnerPort

10th european biotechnology guide 2020 166 | 167


Name · Tigermed Tigermed
As a clinical CRO, we are committed to supporting our
Headquarters address: clients in their clinical development in the best possible
Address/P.O. Box · F15, Dongguan Plaza, No.618 Jiangnan way and every day our experts dedicate themselves to
Avenue, Binjiang District, Hangzhou bringing our client’s products to the market.
Postal Code/City · 310053
Country · China Since our inception in 2004, Tigermed has always em-
Contact Person · Yan Sun braced state-of-the-art technologies and has engaged
Telephone · +86-15615553158 in partnerships that accelerate product development
Fax · +86-571-88211196 and help to generate the clinical evidence required to
Email Address · info@tigermedgrp.com demonstrate real-world value.
Internet Website · www.tigermedgrp.com

Switzerland: Discover our strengths


Name · Tigermed Swiss AG Thanks to our multidisciplinary, knowledge-driven ap-
Contact Person · Stella Gu Placzek proach, Tigermed can deliver a broad portfolio of serv-
Telephone · +41-79-592-7669 ices to the life sciences industry. To this day, we have
Email Address · info@tigermedgrp.com successfully supported thousands of companies rang-
Internet Website · www.tigermedgrp.com ing from start-ups to the largest, established multina-
tional companies and enabled them to bring new drug
Social Media · FL I products and medical devices to the market.
Number of Employees · 5,300+ globally
Founded (year) · 2004 Additionally, we have conducted over 1,500 clinical tri-
Type of Laboratory · Drug development & clinical research als and we are proud to be recognized as “The Innova-
and operations tive Clinical CRO” in China thanks to our involvement in
the development of over 160 innovative drugs.
Areas of Activity · l Regulatory affairs (Regulatory
submission, medical translation, etc.)
l Clinical operations (Clinical trial
development, patient recruitment,
SMO, Medical monitoring, Multi
region clinical trials, etc.)
l Biometrics (dData management,
statistical programming, etc.)
l Technology Services
(Pharmacovigilance, Imaging
analysis, EDC system, central
laboratory, etc.)
l Medical device (Medical device
testing and clinical trial, In vitro
Diagnostic, etc.)
l Post-marketing study and real world
evidence
Tigermed

Acting globally
Our global positioning and organisational structure en-
able our teams to support you with both global reach
and local expertise. Headquartered in Hangzhou, China,
Tigermed operates 33 subsidiaries with 97 offices in
total that are distributed across China and 11 affiliates
at strategic locations across the globe. As a fast-grow-
ing company, we currently employ over 5,300 colleagues
and continuously search for best-in-class professionals
to join our ranks and fortify our global presence.

Your bridge to China


As the leading CRO in China, we are uniquely positioned
to support you in entering the Chinese pharmaceutical
market which is rapidly emerging and offers many unmet
patient needs. Our regulatory experts have years of ex-
perience with the NMPA and are familiar with the subtle
differences in local regulatory requirements. Thanks to
this experience, they can provide you with feasible strat-
egies and act as liaison with various regulatory agencies,
both on technical and regulatory issues.

Keeping up with technology


We have always embraced the latest technology and
have earned a reputation for our visionary thinking in
clinical research. For this reason we are known as the
Innovative CRO in China.

10th european biotechnology guide 2020 168 | 169


Name · Tissue Solutions Ltd Tissue Solutions is a well-established global virtual
– an Intelligent Tissue Group Company biobank sourcing ethically acquired, fully consented hu-
man tissue and biomaterials. We provide a customised
Address/P.O. Box · 1.2, Fleming Pavilion, Todd Campus, tissue provision service, offering a single access point
West of Scotland Science Park for a wide range of high-quality diseased and normal hu-
(plus a European subsidiary in Lyon.) man biomaterials for pre-clinical and clinical research.
Postal Code/City · Glasgow G20 0XA Incorporated in 2007, Tissue Solutions was born when
Country · United Kingdom the founder, Dr Morag McFarlane, spotted a niche in
Contact Person · Dr Morag McFarlane the market after experiencing first-hand the difficulty of
Telephone · +44-141-299-0055 finding reliable sources of human biomaterials.
Fax · +44-141-299-0054
Email Address · morag@tissue-solutions.com We support scientific discoveries to develop new drugs,
Internet Website · www.tissue-solutions.com biomarkers, and companion diagnostics. In addition to
Social Media · F I early stage drug discovery, target identification, and
Number of Employees · 20 validation, samples are also used in clinical trials for
Founded (year) · 2007 pharmacogenomic studies for new drug candidates.
Type of Laboratory · Virtual Biobank Other commercial uses within the biomedical sector
include medical devices, immuno-oncology, biotech,
Areas of Activity · Global virtual biobank and tissue and CROs focused on bringing products to market.
provision services, sourcing ethically
acquired, fully consented human
tissue and biomaterials for pre-clinical Guaranteed Compliance
and clinical research In order to work with confidence in a highly regulated
l Biomarkers, immuno-oncology, area, we work only with sources who comply with strin-
primary dissociated cancer cells gent international ethical guidelines. Tissue Solutions
l Frozen and FFPE tissues, blood, is ISO 9001:2015 certified and guarantees the quality
plasma, serum, bone marrow, urine, and the compliance of all samples. Excellent customer
saliva, sputum, synovial fluid, CSF, service is at the core of our company values.
& ascites
l Primary cells, PBMCs, and Cord Blood
Mononuclear Cells, and highly Global Supply Chain
purified monocyte, T-cell, and B-cell Tissue Solutions operates an international business,
subsets with basic or enhanced delivering to clients worldwide. Working in this way we
characterisation can supply a greater variety of tissues than a single
l iPS cells & dissociated tumour cells biobank, meeting stringent requirements and tight
deadlines more efficiently. This approach means that
Request for · The Tissue Solutions team will be the products supplied are not restricted to a specific
Further Collaborations pleased to learn more about your disease or tissue type.
research and help to source human
biomaterial for your projects.

European
Member of Biotechnology
NET WORK
tissue solutions

Products & Services


Banked Samples
Frozen, FFPE tissues, bloods, plasma, serum, bone
marrow, urine, saliva, sputum, synovial fluid, CSF, and
ascites from a wide range of disease areas. Primary
cells, primary dissociated cancer cells, PBMCs, and
Cord Blood Mononuclear Cells, and highly purified
monocyte, T-cells, and B-cell subsets with basic or
enhanced characterisation. iPS cells & dissociated
tumour cells.

Research Tissue Bank


We have our own Research Tissue Bank Licence to col-
lect and supply a range of samples from living donors,
including skin biopsies and fresh blood samples deliv-
ered within a few hours of collection. This status also
allows researchers in the UK to work under our ethics if
they do not have their own in place.

Custom Prospective Collections


Our Tissue Procurement Team is extremely experienced,
with a proven track record in the provision of “tough”-to-
collect samples. We handle all aspects of the collection,
from set up at the clinical site to project management of
the collection, storage, and delivery.

Transport Logistics
We coordinate all logistics and paperwork, including
expediting materials through customs. We can imple-
ment programmes anywhere in the world, and guarantee
sample integrity.

Additional Services
Tissue Solutions is part of The Intelligent Tissue Group,
which offers clients a single point of access to an
integrated range of tissue procurement and tissue-
related CRO services. As well as Tissue procurement,
The Intelligent Tissue Group offers a range of comple-
mentary services through their company HistologiX Ltd.
including GLP/GCP-compliant Immunohistochemistry
(IHC), Histology and Digital Pathology and Image Analysis
services. The HistologiX team partner with clients at all
stages, from target identification, biomarker development,
and in vivo studies to full clinical trial assessments.

10th european biotechnology guide 2020 170 | 171


Name · Tosoh Bioscience GmbH Tosoh Bioscience is an acknowledged global leader in
the field of liquid chromatography with a focus on bio-
Address/P.O. Box · Im Leuschnerpark 4 separations. For more than 30 years, Tosoh Bioscience
Postal Code/City · 64347 Griesheim is providing cutting-edge solutions to meet the needs
Country · Germany of customers developing and producing new biologics,
Contact Person · Regina Roemling biosimilars or biobetters, such as plasma products,
Telephone · +49-6155-7043700 monoclonal antibodies, recombinant proteins, vaccines
Fax · +49-6155-8357900 and oligonucleotides.
Email · Info.tbg@tosoh.com
Website · www.tosohbioscience.de Our product portfolio encompasses SEC instruments
Number of Employees · >20 and a comprehensive line of media and prepacked proc-
Founded (year) · 1989 ess development, HPLC, and UHPLC columns. These
Areas of Activity · Supplier of chromatography media, products are popular in the biotech and biopharmaceu-
HPLC and UHPLC columns tical industry and used in R&D, downstream processing,
and quality control. Typical applications comprise the
Application support in analysis and purification of therapeutic proteins in lab, pilot, and com-
purification of biomolecules. mercial scale, as well as their characterisation by HPLC
or UHPLC. Latest developments comprise TOYOPEARL
rProtein A and L for the capturing of antibody constructs,
salt tolerant ion exchange and mixed-mode media, and
a revolutionary HPLC column for the analysis of IgG
glycoforms based on their affinity to the Fc receptor,
TSKgel FcR-IIIA-NPR. Recently, the award winning
LenS3TM MALS detector for(U)HPLC and GPC - the most
profound innovation in light scattering technology for
decades – has been introduced in Europe.

Headquartered in Griesheim Germany, in the Frankfurt/


Rhine-Main Metropolitan Region, Tosoh Bioscience’s
European operations offer extensive technical support
like application development, on-site training and work-
shops. One of the services that stand out in the industry
is the Tosoh Chromatography Workshop Series provid-
ing a comprehensive background to the chromato-
graphic purification of biomolecules.
Tosoh Bioscience

Tosoh Bioscience is part of the Tosoh Group, a Japanese


chemical and speciality products and materials group,
founded in 1935, which comprises over 100 companies
worldwide and a workforce of more than 11,500 people.

Our brands TOYOPEARL® and TSKgel® are renowned


for their quality and reliability. The stationary phases
cover all common modes of liquid chromatography,
including ion exchange, hydrophobic interaction (HIC),
mixed-mode, reversed phase, hydrophilic interaction
(HILIC), size exclusion (SEC) and affinity.

10th european biotechnology guide 2020 172 | 173


Name · TRIGA-S Scientific Solutions TRIGA-S is a privately-owned CRO (audited member of
the BVMA), certified according to DIN EN ISO 9001 and
Address/P.O. Box · Mühltal 5 a well-established partner for the In-Vitro-Diagnostic
Postal Code/City · 82392 Habach (IVD) and Medical Device industry. We offer complete
Country · Germany service or tailor-made solutions for clinical studies
Contact Person · Dr Jens Hain and laboratory service including analytical and clinical
Telephone · +49-8847-695-78-45 performance studies in our S2 contract laboratory as
Fax · +49-8847-695-78-29 well as sample processing, sample storage and study
Email Address · info@triga-s.de logistics. Our GCP/GCLP trained teams work according
Internet Website · www.triga-s.de to IVDR, MDR and national regulations.
Social Media · I
Number of Employees · 80 Study Management
Founded (year) · 1998 ·· Study preparation incl. literature research for clinical
Type of Laboratory · S2 contract laboratory evaluation of IVD/Medical Devices
·· Risk-based planning and monitoring of all processes
Areas of Activity · Analytical and clinical studies for IVDs in all project phases
and clinical studies for Medical ·· Medical writing and selection of suitable study sites
Devices ·· Contracting, creation of Case Report Forms (CRFs)
l Study management Patient Information and Informed Consent
l Study monitoring ·· Compilation of documentation, application and sub-
l Biostatistics mission to competent national and international au-
l Sample processing thorities (CA) and ethics commitees
l Sample storage ·· Coordination of monitoring process, data manage-
l Study logistics ment and data analysis
l Laboratory services ·· Regulatory and organisation of scientific advice of
CA and notified bodies
External · Various cooperations ·· Biostatistics
Collaborations (with other SMEs) ·· Support during the CE-certification
·· Post Market Clinical Follow-up
Request for · Triga-S seeks synergistic
Further Collaborations collaborations in the field of Study Monitoring
clinical development of IVD and ·· Establishment of study documentation (TMF), moni-
Medical Devices toring plan, preparation of CRFs and training mate-
rial
·· Study site supply with all study material
·· Site initiation and training of study team
·· Detailed monitoring of clinical trials (On-Site/Remote)
and reporting to sponsor
·· Source data verification (SDV)
·· (S)AE/(S)ADE-documentation and -reporting
·· Study close out and Post-Market-Surveillance
triga-s

Study Logistics
·· Organisation of entire study logistics worldwide
·· Storage, administration and shipping, organisation of
shipping documentation and customs clearance
·· Coordination sample collection logistics worldwide
·· Acquisition of study-specific sample material

Contract Laboratory
·· Measurements on platforms for clinical chemistry,
immunology and ELISA, PCR measurements
·· Sample measurement according to ethical specifica-
tions: exploratory-, pilot-, multicenter- and post
launch studies
·· Takeover of routine work (e.g. application work for
new platforms)
·· Consulting in measurement design and biostatistics
·· Data management and transmission as required
·· Measurement protocol and final study documentation
·· Measurements and CLSI-compliant analytical perform-
ance evaluation using customer-specific platforms
·· Point-of-Care Testing (POCT)

Sample Processing
Collection sets for sample collection studies
·· Individual advice and manufacturing of tailor-made
kits for blood drawing, barcoding of sample tubes and
administration in a LIM-System
Sample management and sample collection
·· Administration in a LIM-System – from sample entry
until shipment
·· Prospective and retrospective sample collection
studies, anonymized left-over samples, healthy donor
samples (serum and plasma)
Sample processing
·· Preparation of sample material for technical/analytical
requirements (application work), enrichment with vari-
ous analytes, preparation of sample panels in measure-
ment tubes compliant with client specifications

Sample Storage
·· Long- and short-term storage (controlled conditions:
from -80° C to room temp.)
·· Electronic 24/7 temperature monitoring
·· Conformity with the standards for traceability

10th european biotechnology guide 2020 174 | 175


Name · UGA Biopharma GmbH UGA Biopharma is an expert in the area of developing
mammalian cell lines for biopharmaceutical products.
Address/P.O. Box · Neuendorfstr. 20a We offer customised cell line development services for
Postal Code/City · 16761 Hennigsdorf new biological entities (NBEs) and biosimilars. UGA’s
Country · Germany mission is to deliver high-end contract services that
Contact Person · Dr Lars Kober satisfy and exceed customer expectations. With our
Telephone · +49-3302-2024-900 dedication to constantly improving our operations, we
Fax · +49-3302-2024-901 see ourselves as a reputable and prosperous player
Email Address · info@ugabiopharma.com known for quality and reliability.
Internet Website · www.ugabiopharma.com
Number of Employees · 38
Founded (year) · 2009 Customised Cell Line Development
Type of Laboratory · S1 Services
UGA Biopharma is the right partner for industry and
Areas of Activity · l Cell Line Development Services academia when it comes to the development of cell
l New Biological Drug Development lines expressing biologics for clinical trials and market
l Biosimilar Development access. We guarantee consistently high quality and
l Ready-to-Use Biosimilar Cell Lines full traceability of Cell Line Development activities. Our
l Cell Culture Media and Feeds proprietary approach for success is a combination of
host cell line, optimised expression vector, and high
Request for · UGA Biopharma is seeking performance First CHOice® medium and feeds. Unique
Further Collaborations l Strategic partnerships for upscaling and long lasting expertise in cell line development,
and GMP manufacturing bioprocess optimisation, downstream processing, and
l Collaboration for development of analytics complete our services.
NBEs or biosimilars
l Cooperation partners for in-licensing
our Ready-to-Use Biosimilar Cell Lines Ready to Use Biosimilar Cell Lines*
Biologics are one of the most cost-intensive treatments
We would be happy to discuss your on the global market today, which implies the need
request. for low-cost alternatives. UGA has gained its expert
knowledge by developing biosimilar cell lines for ten
years now. UGA ensures high analytical biosimilarity
by balancing clone choice, USP process, and DSP
development carefully for each biosimilar. Besides de-
veloping a biosimilar cell line on request, we promote a
broad spectrum of Ready to Use Biosimilar Cell Lines,
including documentation, which are ready to out-license
to a collaboration partner:
·· Adalimumab
·· Bevacizumab
·· Darbepoetin alfa
·· Ipilimumab
·· Natalizumab
·· Nivolumab
uGA biopharma

·· Omalizumab
·· Panitumumab
·· Pembrolizumab
·· Pertuzumab
·· and many more …

High Performance First CHOice ®


Medium and Feeds
First CHOice® Medium is a high performance cell culture
medium optimised for mammalian cell lines. In combina-
tion with CHOice® Feeds it has been optimised to boost
the cell growth and productivity in batch, fed-batch, and
perfusion processes. The completely chemically de-
fined, animal component- and protein-free medium has
been developed in close cooperation with customers us-
ing CHO-S, CHO-DG44, and CHO-K1 cell lines in order
to minimise stress-related metabolites such as lactate
and ammonia. In this way high product quality and cell
viability is guaranteed during all cultivation phases.

*Disclaimer: Until the expiration of the patent and potential supplemen-


tary protection certificates related to the reference medicinal product
the client must not (i) produce, offer or put on the market the respective
medicinal product or possess the product for such purposes, or (ii)
use the cell lines or products offered by UGA Biopharma except for
experimental use or for studies and trials necessary to obtain a market-
ing authorization for medical products in accordance with Art. 11 No.
2 and 2b of the German Patent Act. The client undertakes to pay to the
patent holder for each case of contravention against the undertaking set
forth in the preceding sentence a penalty, the amount of which shall be
determined by the patent holder at its reasonably exercised discretion
and in case the PARTNER considers patent holder’s determination of
the penalty to be not equitable judicially reviewed upon request of the
PARTNER by the patent litigation chamber of the district court in Düs-
seldorf (Germany).
Brand names of reference medicinal products within this presentation
are the trademarks of different pharmaceutical companies with whom
UGA does not have any business or licensing relationship.

10th european biotechnology guide 2020 176 | 177


Name · VAXIMM AG VAXIMM AG is a privately held, clinical-stage, Swiss/
German biotech company developing oral T-cell im-
Address/P.O. Box · Technologiepark Basel munotherapies for patients suffering from cancer.
Hochbergerstrasse 60c VAXIMM is headquartered in Basel, Switzerland. Its
Postal Code/City · 4057 Basel wholly owned subsidiary, VAXIMM GmbH, located in
Country · Switzerland Mannheim, Germany, is responsible for the Company’s
development activities.
Operations:
VAXIMM GmbH Technology
Address/P.O. Box · Harrlachweg 2 VAXIMM’s technology is based on first-in-class oral
Postal Code/City · 68163 Mannheim T-cell activators that can be readily adapted to target
Country · Germany a wide range of cancer-related antigens. The platform
is based on the live attenuated bacterial vaccine strain
Contact Person · Dr Heinz Lubenau, CEO & Co-Founder Ty21, which has been administered to millions of people
Telephone · +49-621-8359687-0 as a prophylactic vaccine to temporarily protect them
Email Address · info@vaximm.com from typhoid fever. This strain has been proven to be
Internet Website · www.vaximm.com very safe and well tolerated. All immunotherapies resul-
Number of Employees · 10 ting from this platform are taken orally by the patient.
Founded (year) · 2008
Type of Laboratory · R&D After oral ingestion, the modified Ty21a bacteria, which
contain the cDNA of the desired cancer target(s), pass
Areas of Activity · l Oncology drug development the stomach and invade the patient’s Peyer’s patches
l Oral T-cell immunotherapies located in the small intestine. Uptake of the bacteria in
l Neoantigens macrophages, the eating cells present in these lymphoid
tissues, leads to strong expression of and subsequent-
External · Clinical collaboration with Merck KGaA ly to a specific cellular immune response towards the
Collaborations and Pfizer Inc. to evaluate VXM01 in encoded cancer antigen(s). These so-called “killer”
combination with avelumab T-cells then destroy the respective antigen-expressing
tumor or tumor stroma cells.
Development and commercialization
agreement with China Medical System The oral bacterial technology enables delivery to the
Holdings for China and other Asian most immunocompetent organ of the body, targeting the
countries (excluding Japan) lymphatic tissue of the gut, and has been shown to
generate robust T-cell responses against many different
Clinical trial collaboration with NEC antigens in animals and humans in first clinical studies.
Corporation to develop personalized
neoantigen cancer vaccines The low therapeutic doses required for specific T-cell
activation make this approach suitable for continuous
Request for · New development partnerships and dosing (prime & boost administrations), without raising
Further Collaborations collaborations with both industry anti-carrier immunity, and provide another safety margin
and academia for the proprietary for carrier-related toxicity.
oral T-cell activation therapy platform
and product candidates are welcomed The platform is suitable for addressing multiple targets
with one treatment and can be combined with addi-
vaximM

tional immune therapies. Other major advantages of this


approach include the high modularity (plug and play),
the low cost and robustness of the production process,
and the rapid development timelines to take products
from concept to clinic.

Product pipeline
The Company’s lead product candidate, VXM01, is an in-
vestigational oral T-cell immunotherapy targeting VEGFR2
that is designed to activate T-cells to attack the tumour
vasculature, and, in several tumour types, attack cancer
cells directly. A Phase I/II trial in advanced pancreatic
cancer showed that VXM01 was well tolerated and led to
Mode of Action the activation of VEGFR2-specific cytotoxic T-cells, which
Intra-lymphatic Delivery via Oral Administration was associated with significantly improved patient sur-
vival. An additional clinical Phase IIa trial in metastatic
colorectal cancer has been completed. Single-agent activ-
ity was shown in an ongoing trial in recurrent glioblastoma
where two objective clinical responses and long-term
survival compared to historical controls have been ob-
served. Based on these data, VXM01 has received orphan
designation from the European Commission and from the
US Food and Drug Administration (FDA) for the treatment
of glioma, a difficult-to-treat form of brain cancer.

Additionally, VAXIMM has a collaboration agreement


with Merck KGaA, Darmstadt, Germany, and Pfizer Inc.
to evaluate avelumab, a human anti-PD-L1 antibody, in
combination with VXM01. Under the terms of the agree-
ment, VAXIMM has started an open-label Phase I/II trial
in progressive glioblastoma patients. Preclinical data
support that adding VXM01 to treatment with a check-
point inhibitor may increase survival.

VAXIMM’s neoantigen program is in preclinical develop-


ment and has already shown immune proof of concept;
the Company’s platform allows for fast generation and
delivery of personalized T-cell vaccines and may over-
come key issues with other neoantigen approaches. A
clinical Phase I basket study in collaboration with NEC
is currently in preparation. Additional programs are in
pre-clinical development and can be developed as
stand-alone therapies or in combination with other im-
munotherapies.

10th european biotechnology guide 2020 178 | 179


Name · Vetter Pharma International GmbH A strategic partner
focused on your success
Address/P.O. Box ·
Eywiesenstrasse 5 Vetter is an international specialist in the production of
Postal Code/City ·
88212 Ravensburg aseptically prefilled syringe systems, cartridges, and
Country ·
Germany vials. We are a family-owned, independent company
Contact Person ·
Johannes Clemens and do not manufacture our own drugs. Our focus is on
Telephone ·
+49-751-3700-0 providing highly skilled support and state-of-the-art
Emails ·
EU and other international inquiries: manufacturing resources – from the initial phases of
info@vetter-pharma.com clinical development and the regulatory approval proc-
US inquiries: ess to successful product launch, commercial manu-
infoUS@vetter-pharma.com facturing, and life cycle management. Vetter has exten-
Japan inquiries: sive experience with biologics and other complex
infoJapan@vetter-pharma.com compounds. More than 80% of Vetter’s active projects
Asia Pacific inquiries: are biologics.
infoAsiaPacific@vetter-pharma.com
Website · www.vetter-pharma.com Resources for every stage of growth
Number of Employees · Approx. 4,900 Vetter’s full portfolio of services includes dedicated
Founded (year) · 1950 resources for both clinical development and commercial
manufacturing. In addition, we provide expert packag-
Areas of Activity · l Development support ing technologies and solutions tailored to your product’s
l Aseptic contract manufacturing specific market needs.
of prefilled syringes, vials and
cartridges Vetter Development Service
l Assembly and secondary packaging Planning for success
services Preclinical through Phase III is a pivotal and unpredict-
able period for new molecules. Vetter Development
Service helps smooth the path to clinic with dedicated
support for key stages of development, testing, clinical
manufacturing, and regulatory approval. We also help
you integrate thoughtful, efficient life-cycle solutions for
long-term growth and success. Vetter Development
Service provides:
·· Formulation support
·· Process development
·· Clinical trial manufacturing
·· Analytical services
·· Regulatory support

Vetter Commercial Manufacturing


Filling your potential
Precise manufacturing. Creative thinking. It takes both
to succeed in a competitive marketplace. Vetter Com-
mercial Manufacturing supports your injectable with
more than 35 years of expertise in high-quality, state-
vetter pharma international

VETTER DEVELOPMENT SERVICE of-the-art aseptic filling – and experience-based solu-


tions that add value and increase efficiency. Vetter
Commercial Manufacturing provides:
·· Fill and finish
·· Analytical services
·· Regulatory support
·· Product life cycle management

Vetter Packaging Solutions


Packaging matters
Material compatibility. Patient convenience. Market dif-
ferentiation. There are many factors to consider in the
selection of your primary and secondary packaging ma-
terials. Which ones matter most to your compound’s
performance and long-term potential? Vetter’s packaging
VETTER COMMERCIAL MANUFACTURING experts help you find the right solutions throughout your
product’s life cycle. Vetter Packaging Solutions provides:
·· Customised packaging development
·· Specialised technologies
·· Proven platform technologies
·· Packaging services
·· Serialisation services
·· Logistic services

Fast facts: Vetter-at-a-glance


·· Headquarters in Ravensburg, Germany
·· Commercial production sites in Ravensburg and
Langenargen, Germany
·· Additional clinical development facility in Chicago, US
·· Branch offices for Asia Pacific in Singapore and South
VETTER PACKAGING SOLUTIONS
Korea, as well as a subsidiary in Japan
·· Approximately 4,900 employees
·· Worldwide specialist in the aseptic production of
prefilled drug delivery systems
·· Global experience and expertise with regulatory au-
thorities including FDA, EMA, PMDA (Japan), and RP
(Germany)
·· Service offering for small and large pharma/biotech
firms worldwide
·· Numerous patents including technologies for protec-
tion against tampering and counterfeiting
·· Lyophilisation (freeze-drying) and siliconisation spe-
cialist

10th european biotechnology guide 2020 180 | 181


Name · Vibalogics GmbH Vibalogics is a privately-owned contract development
and manufacturing organisation (CDMO) offering serv-
Address/P.O. Box · Zeppelinstr. 2 ices for companies developing therapeutic biological
Postal Code/City · 27472 Cuxhaven products. With a specific focus on oncolytic viruses,
Country · Germany viral vectors for gene therapies, we work in full compli-
Contact Person · John Shaw ance with international GMP standards in our BSL-2
Telephone · +49-4721-565-400 classified state-of-the-art facility in Germany.
Email · experts@vibalogics.com
Website · www.vibalogics.com We place the greatest value on being a reliable partner
Social Media · I and offering a high quality, highly flexible service to our
Number of Employees · 50 customers. Our services include:
Founded (year) · 2006
Type of Laboratory · Biologics CMO
Virus production
Areas of Activity · l Live virus We offer state-of-the-art production of viruses tailored
l GMP manufacture to our customers’ requirements. We perform process
l Process development development, cGMP manufacturing, aseptic fill and
l BSL-2 fill and finish lyophilisation finish including lyophilisation, batch-release testing, and
development QP release.
l Formulation development ·· Cell banking and characterisation
l Immunotherapy ·· Virus seed stock generation and characterisation
l Gene therapy ·· Feasibility studies and productivity optimisation
l Vaccines ·· Genetic stability studies
·· Assay development including infectious particle,
genomic virus particle, and total particle
·· Primary cell culture (CEFs) suitable for viruses such
as MVA
·· Production of oncolytic viruses and gene vectors
·· Production in roller bottle, Cell FactoryTM, T-flask,
HYPERFlaskTM, and iCELLisTM systems
·· Single-use, scalable bioreactor technology

Egg-based virus production


Our comprehensive knowledge of all aspects of egg-
based virus production offers a distinct advantage to
our customers. Virus material can be harvested from
allantoic and amniotic fluids or chicken embryos.
·· cGMP virus production on SPF eggs
·· Batches of up to 5,000 eggs
·· Expertise in the manufacturing of DNA and RNA
viruses
Vibalogics

cGMP fill & finish


Our focus is the filling of liquid and lyophilized drugs in
vials. Validated cleaning procedures are established to
prevent cross-contamination. Routine media fills for
standard formats are performed.
·· Liquid and lyophilised products up to BSL-2
·· Development lyophiliser for non-GMP batches and
formulation/ Lyo. cycle development
·· Grade A/B clean room for manual and automatic
operations
·· Manufacturing batch scale:
·· Manual filling of up to 1,500 vials
·· Automatic filling of up to 30,000 vials
·· Lyophilisation of up to 3,000 vials
·· Validated processes in place
·· Semi-automatic visual inspection
·· Packaging and labelling

Quality control
·· Development, establishment, and cGMP-compliant
performance of compendial and customer-specific
tests
·· Sterility and identity testing
·· Molecular biological methods such as restriction
analysis and PCR
·· Physical testing such as residual moisture, pH, and
vacuum testing
·· Potency testing such as TCID50 and EID50
·· Stability testing according to ICH guidelines

10th european biotechnology guide 2020 182 | 183


Name · Vivoryon Therapeutics AG Vivoryon Therapeutics (Euronext Amsterdam: VVY) has
an experienced discovery and development team with
Address/P.O. Box · Weinbergweg 22 a strong track record in delivering therapies to patients.
Postal Code/City · 06120 Halle (Saale) We have product candidates in both clinical and pre-
Country · Germany clinical development and concentrate on age-related
Contact Person · Dr Ulrich Dauer diseases with unmet medical needs.
Telephone · +49-345-555-99-00
Fax · +49-345-555-99-01 Vivoryon Therapeutics is focusing on the discovery of
Email Address · info@vivoryon.com therapeutics with action on disease-relevant enzymes.
Internet Website · www.vivoryon.com Our active research programmes involve glutaminyl
Social Media · LI cyclases. One of the two homologues is QPCT and is
Number of Employees · 16 primarily expressed in the brain; the other one, QPCTL,
Founded (year) · 1997 is more broadly expressed in healthy and cancerous
tissues. Both enzymes catalyse the transformation of an
Areas of Activity · l Life Science N-terminal-residing glutamine or glutamate amino acid
l CNS/NeuroScience into their cyclic form called pyroglutamate.
l Cancer
The main physiological functions of this cyclisation is
exemplified by the PQ912 mode of action in Alzheimer’s
diseases and cancer respectively.

QPCT in Alzheimer’s disease


QPCT is a post-translational modifying enzyme which
catalyses the pyroglutamate formation of N-terminal re-
siding glutamine or glutamate amino acids in substrate
proteins. This cyclisation has two main physiological
functions: one is the mediation of protein-protein inter-
actions, the other is the stabilisation of peptides and
chemokines. Both of these events can have significant
impact on protein functionality in health and disease.

In Alzheimer’s disease QPCT has been identified as


the crucial human brain enzyme for the generation of
very stable and sticky pyroglutamate (pGlu) species of
Abeta. Findings from various parties strongly support
that these pGlu species are especially neuro- and syn-
aptotoxic and correlate with AD disease progression.
Vivoryon

QPCTL in cancer
The CD47/ SIRPa interaction is an important myeloid
immune checkpoint whose clinical relevance has been
shown by successful application of CD47 antibodies in
cancer therapy. CD47 is expressed on cancer cells and
SIRPa on myeloid cells such as macrophages and NK
cells. QPCTL is critical for pyroglutamate formation on
the N-terminus of CD47 shortly after biosynthesis. The
formation of pyroglutamate on CD47 is essential for the
binding of SIRPa. Thus, QPCTL is a novel and attractive
target to silence the “do not eat me” signal provided by
the CD47/SIRPa interaction.

As opposed to antibody approaches in clinical develop-


ment our small molecule QPCTL inhibitors are a first-in-
class and innovative therapeutic approach for boosting
the efficiency of cancer immunotherapy.

10th european biotechnology guide 2020 184 | 185


Name · YUMAB GmbH YUMAB is a contract developer of fully human antibod-
ies for the global biotechnological and biopharmaceuti-
Address/P.O. Box · Science Campus Braunschweig-Süd cal industry. Starting out in 2012 with the goal to bridge
Inhoffenstr. 7 the gap between innovative research and novel thera-
Postal Code/City · 38124 Braunschweig pies, the company has become an important driver of
Country · Germany the general trend in immunotherapy toward the use of
Contact Person · Dr Linda Kirchner fully human antibodies.
Telephone · +49-531-481170-0
Email Address · info@yumab.com The versatile technology platform combined with a
Internet Website · www.yumab.com longstanding and proven expertise makes YUMAB the
Social Media · I Q partner of choice for the development of novel antibod-
Number of Employees · 24 ies for therapeutic applications, diagnostics, or vaccines
Founded (year) · 2012 tailored to the clients’ needs. R&D projects customised
Type of Laboratory · S1, S2 with flexible entry and exit points at any stage and for
any immunotherapeutic strategy appeal to start-ups,
Areas of Activity · l Fully human antibody discovery & biotech, or biopharma companies.
lead development
l Antibody Libraries In 2018, YUMAB moved its headquarters and labs to
l Engineering & Humanization one of Germany’s life science hotspots, the Science
l Professional R&D services (CRO) Campus Braunschweig-Süd, to enable sustainable
l Optimised conditions for start-up, growth and high-level scientific partnering.
biotech & biopharma companies
l Flexible entry & exit points at any
project stage The YUMAB® platform: fast & reliable
l Partnered innovation translation from innovation to drugs
The YUMAB® R&D platform delivers fully human anti-
Request for · YUMAB seeks clients & partners in bodies, the closest to natural germline among those
Further Collaborations biopharma, biotech, & diagnostic on the market, using fast and reliable in vitro discovery
industry as well as partners with technologies.
innovative research projects, who need
a reliable partner in human antibody The company’s highly diverse, human antibody librar-
development ies contain 1011 natural antibody sequences and spe-
cificities to all types of antigens. Unlike animal-derived,
chimeric, humanised, or synthetic antibodies, each
YUMAB® antibody sequence has been shaped in the
human body, which maximises epitope diversity and
overcomes restriction by in vivo immune responses
while minimising immunogenicity and potential adverse
effects in clinical development.

Our advanced in vitro selection technology is also


efficient for rare and difficult target antigens and al-
lows pre-design of epitope specificity, interspecies
X-reactivity, affinity, stability, and other properties early
yumab

in the discovery and development process. First anti-


body candidates are identified swiftly within a few weeks
and are highly developable into all types of antibody drug
formats such as full-length IgGs, Fabs, scFvs, bispecif-
ics, CARs, fusion proteins, and ADCs.

YUMAB provides tailored service and partnering con-


cepts to jump-start translation from research innova-
tion to drug development with affordable entry costs,
flexible licensing options, and no additional third-party
obligations.

YUMAB at a glance
Human antibody discovery platform
·· Natural fully human libraries for low toxicity
& immunogenicity
·· Optimised in vitro selection to address
difficult targets
·· Rapid discovery within weeks

Direct link to lead development


·· Advanced antibody lead development & optimization
·· All antibody drug formats, all disease areas
·· Robust & fast process with high success rates

YUMAB® platform
·· Fully integrated discovery & development platform
from target to optimized lead
·· Customised project plans with flexible entry
& exit points
·· Smooth translation from bench to bedside

Flexible services, collaborations & partnering


·· Contract R&D as fee-for-service & flexible licence

FULLY HUMAN ANTIBODY options


·· No technology access fees
·· Partnered collaboration to translate research
DISCOVERY PLATFORM innovation into drug development

10th European biotechnology guide 2020 186 | 187


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ternationally less savvy) find a comprehensive partner
Leading chemical companies are exploring the op- which is helping to put them in the public window. ...is an alliance of four leading Biotech regions of
portunities that have been opened up by modern bio- The participating Life Science Regions are important Switzerland (Bio Alps, BioPolo Ticino, Basel Area
technology, especially in the field of “white” or indus- internal carriers of the dynamics in the Biotech sec- and Greater Zurich Area). They have combined ef-
trial biotechnology. And they are also applying these tor, thus enhancing the common understanding of the forts to streamline interests of the national biotech
technologies, wherever it makes sense. The SBA takes industry. This and more knowledge is brought into sector. The SWX Swiss Exchange holds a leading
Supporting partners: Media partners:
such initiatives seriously and has formed a working Europa Bio, the European Biotech Association, where position in terms of lifescience listings and offers
group specifically dedicated to white biotechnology. the SBA is an active member. companies from that industry – be they located in
The Swiss Industrial Biocatalysis Consortium is an Switzerland or abroad – access to an international-
important partner in this effort. The group includes ly recognised financial marketplace. The initiative
leading multinational companies that support white was co-founded by the SBA which also manages
biotechnology as a pillar of economic growth. The the executive office of Swiss Biotech.
Organized by:
planned activities are in agreement with OECD
strategies.
European In partnership with the Swiss Biotechnet (see pages
Biotechnology
14/15) the SBA develops training programmes and use-
NET WORK
ful support tools for the industry. It is of importance
that the industry specifies its training needs so that
the academic side can create tailor-made education.
This strategy ensures that the industry gets the right Domenico Alexakis
Find the digital issues and much more on
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VOLUME 10

2020

10th European Biotechnology Guide


European
Biotechnology
Guide
Science & Industry

European
ISBN 978-3-928383-75-2 Biotechnology
NET WORK

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