Professional Documents
Culture Documents
2020
European
ISBN 978-3-928383-75-2 Biotechnology
NET WORK
European
Biotechnology
Guide
Science & Industry
© BIOCOM AG, Berlin 2020
Published by:
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ISBN: 978-3-928383-75-2
Editorial
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
european-biotechnology.com
Interested?
For more information, just head to www.biocom.de/comdis
or contact Dr. Boris Mannhardt at b.mannhardt@biocom.de
Picture: rakchai/fotolia.com
Introduction
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.
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
Our videos tell stories. The people behind research and de-
velopment come to life. We combine the essence of film
– tension, atmosphere, emotion – with the precise informa-
tion of science communication. Our unique videos facilitate
access to the life sciences while at the same time attracting
attention and imparting knowledge.
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)
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.
AFM24
Innate cell target: CD16A
Tumour target: EGFRwt
Process development
·· Upstream development
·· Downstream development
·· Analytical development
Process development
·· Upstream development
·· Downstream development
·· Analytical development
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.
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).
Management
Thomas Hoeger, PhD (CEO)
Peter Willinger (CFO)
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.
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.
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).
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.
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
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.
location
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.
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
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.
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.
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.
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
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.
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
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.
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
in 1995.
ES
&
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
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.
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.
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
www.crs-group.de
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.
Management
Dr Ulf Menyes (CEO)
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.
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.
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
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.
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).
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.
EuroPharmaJobs
EuroPharmaJobs is focused on Regulatory Affairs,
Clinical Trials, Biotechnology, Pharmacovigilance, Qual-
ity Assurance, as well as many other types of pharma
industry jobs.
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.
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
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.
Services
Consulting
·· Advice for drug and device development
·· Biostatistical support
Regulatory Affairs
·· Submission
·· All communication with competent authorities and
ethics committees
Medical Safety
·· Adverse Event Management and assessment/reporting
·· Drug Safety, medical monitoring and adverse event
coding
Medical Writing
·· Generation and review of entire spectrum of
regulatory documents
Quality Assurance
·· Regularly reviewed and updated set of SOPs
·· Quality system audited on a regular basis
·· Audits on behalf of sponsors
·· Assistance during inspections
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
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
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)
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
Member of European
Biotechnology
NET WORK
fundación MEDINA
References
GenScript’s US headquarter in New Jersey, US
https://doi.org/10.1021/ja00906a021
https://doi.org/10.1101/2020.02.21.959817
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)
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 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
More information?
Should you have any questions or like to receive more
information about grant opportunities for academia or
industry, please contact us.
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)
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.
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.
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.
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.
Additional services
·· Hybridoma Development
·· Stable CHO cell line development
·· Immunoassay development and production
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.
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
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.
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.
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 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
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
Did you just get funding? Or are preparing to get to clinic and
IND filing? Contact us today to talk about your next steps.
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).
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.
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.
People
Dr Markus Schmid, Christof Wunderlin (Co-CEOs)
Dr. Christoph Grünig (Head of Contract Research)
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.
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.
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.
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
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.
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.
CyclASol®
CyclASol® is an anti-inflammatory investigational drug
for patients with moderate to severe DED with an inflam-
matory disease component.
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
Management
Dr Christian Roesky (CEO)
Dr Oliver Schlüter (CFO)
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
European
Member of Biotechnology
NET WORK
op2
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
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
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.
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.
·· Project management
·· Regulatory support
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.
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.
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
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
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.
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.
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).
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
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.
European
Member of Biotechnology
NET WORK
talk biotech
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!
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
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.
European
Member of Biotechnology
NET WORK
tissue solutions
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.
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
·· Omalizumab
·· Panitumumab
·· Pembrolizumab
·· Pertuzumab
·· and many more …
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.
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
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.
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
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
eurobiotechjobs.net
Aug 24|25
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ful support tools for the industry. It is of importance
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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
workforce with the right education. The SBA profits is Executive Director For further information please visit
from the marketing alliance “Swiss Biotech” (see box) of the Swiss Biotech www.swissbiotechassociation.ch
in a multiplied form. Thanks to Swiss Biotech, the Association. www.swissbiotech.org
amr-conference.com
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SWISS BIOTECH DAY 2020
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21 April 2020
What you can expect in 2020:
Congress Center Basel
› Around 900 senior life science experts from 25+ countries
› 50+ exhibitors and international delegations
› Presentation of the Swiss Biotech Report
Wir wollen die
› Swiss Biotech Success Stories Awards
› Innovative biotech start-ups and medium-sized biotech companies
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› Thematically focused panel discussions
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› Pre-scheduled one-to-one partnering meetings
› High-traffic exhibition with ongoing catering www.swissbiotechday.ch
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VOLUME 10
2020
European
ISBN 978-3-928383-75-2 Biotechnology
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