THE LATEST IN DIGITAL HEALTH CONTINUOUS FLOW BENEFITS A GUIDE TO PROCESS EQUIPMENT

July/August 2019

UNSURE WHO TO TRUST?

Contec explains where to place your trust when
it comes to EU Biocidal Products Regulations
Science on
demand
Make us an integral part of your
supply chain and allow us to help you
achieve your Continuous Production
or Just-In-Time Production goals.

Schedule your analysis at our

FDA and MHRA approved contract
analytical laboratory to ensure that
your workflow runs to plan.

Sarah Healy,
Analytical Chemist

To find out more

call +44 (0)20 8977 0750
email info@butterworth-labs.co.uk

butterworth-labs.co.uk
 Contents
July /August 2019 | Volume 19 Issue 5

REGULARS

5: EDITOR’S DESK
Reece Armstrong flies the flag for LGBT+ people
working in science and engineering.

6: A SMALL DOSE
A brief round-up of some of the latest developments
in the industry.

8: IN THE NEWS
A short selection of stories from the world of science.

10: OPINION
Why labelling is an unassuming challenge
for pharma manufacturers.

14: COVER STORY

Contec guides readers on what to look out for when
complying with EU Biocidal Products Regulation (BPR).

20: ANALYSIS
How new drug development platforms
are boosting innovation in pharma.

FEATURES

16: DIGITAL HEALTH

The three laws of drug development and how technologies
are improving medications.

22: SINGLE-USE
The benefits continuous flow brings to manufacturers.

24: IN PROFILE
Marcus Knöll from Bosch Packaging Technology tells us about
the challenges of working in the industry.

34: FROM THE FACTORY

Five of the latest developments for manufacturing facilities.
 5
HEAD OFFICE
Carlton House, Sandpiper Way, FLYING THE FLAG
Chester Business Park,
Chester, CH4 9QE.
The recent news that Alan Not only does J&J offer
Tel. +44 (0)1244 680222 Turing will be the next face same-sex parents the same
Fax. +44 (0)1244 671074 of the £50 note should be a benefits as heterosexuals, it
Web: www.epmmagazine.com welcome boon to members provides transgender health
of the LGBT+ community. insurance coverage and offers
EDITORIAL same-sex spouses assistance
At the time of writing, Pride with fertility treatments, adoption
editor reece armstrong Month has ended and and surrogacy. Besides this, the
reece.armstrong@rapidnews.com companies around the world company has also donated over
have put their rainbow coloured $1 million to LGBT+ charities.
group editor dave gray branding back into the
david.gray@rapidnews.com
proverbial closet. And yes, for a business that
head of content, life sciences lu rahman, makes billions in profit every year
lu.rahman@rapidnews.com It’s easy to be cynical and this may seem like a paltry
dismiss companies’ efforts amount. Yet without financial
publisher duncan wood towards LGBT+ inclusivity as donations, supportive policies
money-making PR stunts, but in and inclusive workplace
PRODUCTION the pharma industry at least atmospheres – things that
progress is being made. actually make a difference – then
head of studio and production companies will continue to simply
sam hamlyn In the UK, GSK’s efforts into fly the flag every year without
improving workplace culture supporting any LGBT+ efforts.
design robert wood
and life for LGBT+ employees
have been recognised by BUT WHY IS THIS IMPORTANT?
ADVERTISING Without financial Stonewall’s Global Workplace A report released in June by the
robert anderton donations, Equality Index. The company’s Institute of Physics, Royal
tel: +44 (0)1244 952359 supportive policies policies, which protect workers
from discrimination on the
Astronomical Society and Royal
Society of Chemistry highlighted
robert.anderton@rapidnews.com
and inclusive grounds of their sexual that 28% of LGBT+ scientists
head of media sales, plastics & life sciences workplace orientation and gender identity, have considered leaving their
lisa montgomery
lisa.montgomery@rapidnews.com
atmospheres, align well with the words of
Brian McNamara, CEO, GSK
jobs because of discrimination.
More so, the survey of over
companies will Consumer Healthcare. 1,000 employees working in
SUBSCRIPTIONS continue to simply physical sciences, demonstrated
subscriptions@rapidnews.com fly the flag every “Innovation in healthcare that almost half (49%) believe
happens when groups of people there is an overall lack of
year without who are different join together awareness of LGBT+ issues
qualifying readers
Europe - Free, ROW - £249 supporting any with a common aim. Supporting in the workplace.
outside qualifying criteria LGBT+ efforts. LGBT+ inclusion is just one of

EDITOR’S
UK - FREE, ROW - £249 the ways that organisations can In engineering diversity is even
please subscribe online at more limited. A survey of almost
www.epmmagazine.com 7,000 engineers in the UK
shows that only 4% of these
Address changes should be emailed to
are LGBT, with another 5%

DESK
subscriptions@rapidnews.com preferring not to declare their
sexual orientation.
European Pharmaceutical Manufacturer
is published by Rapid Life Sciences Ltd. While this doesn’t necessarily
European Pharmaceutical Manufacturer
is distributed in electronic and print formats to a correlate to a culture of
combined readership of 14,000 pharmaceutical exclusion, it certainly doesn’t
manufacturing professionals. help the argument that
celebrate difference and engineering is dominated
Volume 19 Issue 5 © June 2019 spark innovation.” by straight white men.
While every attempt has been made to ensure that the
information contained within European Pharmaceutical
Manufacturer is accurate, the publisher accepts no liability Other pharma companies too So just remember the next time
for information published in error, or for views expressed. are promoting a healthy culture you see Turing’s face on the
All rights for European Pharmaceutical Manufacturer
are reserved and reproduction in part or whole for the LGBT+ community. front of a £50 note, that science
without written permission is strictly prohibited. is at its best when people of all
Johnson & Johnson for instance sexual orientations, genders and
has been named as one of the identities work together, and that
best pharmaceutical companies nobody should be excluded
to work for and in 2018 was from any industry based on
championed for its LGBT policies. who they are.
BPA Worldwide Membership
ISSN No - 2052-4811
6 A small dose

Biological
enigma
machine
could treat
incurable
diseases

A biological ‘enigma
machine’ could
be the answer to
within the messages,
and understanding
where they come
identifying and from, we have
treating currently developed a range
incurable diseases, of new diagnostic
research suggests. tools to detect
disease faster and
Researchers at enable more effective
The University of treatments with
Sydney and the Royal minimal side effects.
Women's Hospital
Australia developed “Importantly, this
the machine to technique will
interpret the cellular enable us to develop
language used by treatments for
the body. currently incurable
conditions – taking
The machine is able us from palliative
to isolate the warning
signs issued by the
body when something
therapies into cure.”

The team focused

Drug discovery collab
has gone wrong.
Labelled ‘complaint
signals’, the team
on the role tiny
messengers called
extracellular vesicles
targets Parkinson’s d
used these to detect (EVs) play in regulating
diseases quicker than
current techniques
allow.
cellular function, the
individual function
of which had not
A UK-based
biopharmaceutical
company dedicated to
PhoreMost’s phenotypic
screening platform
Siteseeker will be used
neurodegeneration drug
targets.

been determined drugging ‘undruggable’ to guide selection of Dr Chris Torrance CEO

This could potentially until now. Through disease targets novel targets identified of PhoreMost, said:
enable more effective a new technique has announced a by C4XD’s target “Neurodegeneration is
early treatments for using atomic force neurodegeneration identification platform a therapeutic area that
conditions including microscope infrared drug discovery Taxonomy3. This will has a pressing need
Parkinson’s and spectroscopy, the collaboration focusing hopefully provide for new and better
currently incurable team were able to see on Parkinson’s disease. chemical starting points targets. The opportunity
progressive lung how every cell in the to launch drug discovery to incorporate genetic
disorders. body produces a kind PhoreMost will team up programmes. insights gained from
of tiny bubble filled with C4X Discovery to C4XD’s Taxonomy3 data
Author associate with DNA and other use both companies’ It’s hoped that the alongside our
professor Wojciech molecules which they technology platforms to collaboration will bolster Siteseeker screening
Chrzanowski said: “By use to communicate validate novel targets for C4XD’s drug discovery platform has great
detecting complaints with each other. Parkinson’s disease. pipeline of novel potential to reveal
 www.epmmagazine.com
7

CRO
RECOGNISED
FOR
CONTRIBUTION
TO WELSH
ECONOMY

A fast-growing
contract research
organisation (CRO) has
been recognised for its

CERTARA LAUNCHES
contribution to the
Welsh economy.

GLOBAL SCHEME FOR

CatSci was named
‘International Business
of the Year’ at the Cardiff

Business Awards, which
recognises outstanding
export performance in
South Wales.
The company was
also named as one of
the ‘50 Most Exciting
Companies in Wales’ by
Wales Business Insider
magazine.
DRUG DEVELOPMENT
G lobal drug
development
consultancy Certara has
manufacturing and
control (CMC) talent to
tackle CMC challenges.
access approaches that
will deliver effective and
affordable therapies
launched a new practice to populations in
area to help accelerate Certara Global Health need around the
medicines for people has been launched as world. A triple bottom

boration
CatSci says that the
awards reflect the long-
term internationalisation
around the world who a new product inspired line practice across
need them most. by the company’s drug the global health
development and product development
Certara Global scientific work for the ecosystem.”

disease strategy that is targeting

key markets across the
world.
Health will take an
interdisciplinary
approach to accelerating
Bill & Melinda Gates
Foundaiton. “Developing medicines
is expensive and difficult
Simon Tyler, chief drug development “Certara Global Health at the best of times,
highly relevant novel across a range of will bring together and securing talent
operating officer, said:
drug targets. We are areas. These include talent, technology, and capital is an extra
“These accolades are a
tremendously excited model-informed software, systems and challenge for the global
testament to the talent
by the complementarity translational medicine; processes to accelerate health sector,” added
and hard work of all our
of our technologies. innovative clinical trial the development of Kevin Hershberger,
staff. Both demonstrate
C4XD’s Conformetrix designs; regulatory medicines for those that co-lead of CGH. “But
CatSci’s growth into
approach is ideally science approaches to need them most,” said we are confident that
a globally-recognised
suited to use the accelerate reviews Craig Rayner, co-lead of we can play a catalytic
partner for pharmaceutical
3D biological shape and more. CGH. “Working closely role in bringing creative
innovation, and its
information derived with the foundation thinkers together
commitment to life
from Siteseeker and One area Certara Global and other leaders with leading-edge
science in South Wales.
convert this into small Health will tackle is in the global health technologies and
We are proud to be an
molecules starting in delivering quality sector, CGH will focus methodologies, to
integral part of research
points that will lead to medicine to low-middle on creating novel support solving medicine
and development efforts
the next generation of income countries and impactful drug development and access
that lead to life-changing
therapeutics.” through by bringing development, regulatory challenges in global
new therapeutics.”
in new chemistry, science and patient health.”
8 IN THE NEWS

Cervical cancer screening gap for

lesbian women perpetuated by myth
Up to 50,000 lesbian, said: “The misleading need to be inclusive of
gay and bisexual information that gay lesbian, gay, bisexual
women (LGB) are and bisexual women trans and non-binary
missing out on aren’t at risk of this people, and I’m
screening tests for disease is one of the delighted to have been
cervical cancer due to most dangerous myths asked to help the NHS
believing they are not around, because it has address these issues Millions of
at risk. created a screening and more.” children
gap for thousands, missing out
M isinformation
spread in the past
by charities warned
which is a major
concern for our
community.
on lifesaving
vaccines
that women who have Data from the World
sex with women don’t “Let’s be clear: Health Organisation
need to be screened. cancer does not (WHO) and UNICEF
However, the human discriminate. If show that 20 million
papillomavirus (HPV), you’ve got a children around the
which causes cervical cervix, world missed out on
cancer, can be you can lifesaving vaccines
transmitted through any get last year.
type of sexual activity. cervical
A survey conducted by cancer, Poor or conflict-
the LGBT Foundation and as affected countries
MAKE YOUR DREAMS revealed that nearly one cervical were found to
COME TRUE WITH THE LGB women in five has cancer is have the most
MEDTALK PODCAST never been to a cervical preventable unvaccinated
screening appointment. people should children with the
T he MedTalk Podcast’s
latest episode has
landed!
Speaking at Pride
Week, the NHS’ national
take up their regular
screening appointments.
Ukraine suffering
from the highest
number of measles
advisor for LGBT health, “We also know that cases in 2018.
This episode sees the Dr Michael Brady, NHS screening services Dr Tedros Adhanom
editors sit down to Ghebreyesus,
discuss a recent report
looking into the future Did you know? director-general of
the World Health
of global healthcare and Organisation
the technologies shaping said: “While most
the ways we take care of children today are
ourselves. being vaccinated,
far too many
Find out what a recently are left behind.
launched service by Unacceptably, it’s
pharmacy John Bell often those who are
& Croyden means for most at risk– the
holistic healthcare and According to the Nearly all cases of There are over 100 poorest, the most
how a new wearable Centers for Disease cervical cancer can be types of HPV viruses marginalised, those
could let you take control Control and Prevention, linked back to an HPV most of which are touched by conflict
of your dreams. HPV is the most infection. relatively harmless. or forced from their
commonly spread homes - who are
sexual transmitted persistently missed.”
infection (STI).
10
Opinion

By centralising
and digitising
labelling,
pharmaceutical
companies can
create an efficient,
streamlined
process for
producing
accurate,
compliant labels.

HOW A CENTRALISED LABELLING

SOLUTION CAN IMPROVE
PHARMA PROCESSES
T he pharmaceutical industry arguably faces more challenges than most
other industries. Regulatory compliance is part and parcel of working in the
sector, but, in a business where bringing a drug to market carries such a large
investment, cost pressures, particularly when a drug comes off patent, are
perhaps higher than other industries.

Ken Moir
Therefore, finding the balance between complying to regulation, driving
Marketing Director efficiencies in the manufacturing process and maintaining quality can mean
at NiceLabel the difference between being competitive or not. 

A critical part of maintaining compliance and safety standards for any drug
manufacturer is the labelling process. Not only does the label act us a unique
identifier to prove authenticity to healthcare professionals and consumers,
it also ensures that active ingredients and concentrations are clearly
understood. And there can’t be any margin for error as the consequences
of inaccurate doses or ingredients are too high.
 www.epmmagazine.com
In fact, it’s estimated that 50% of pharmaceutical
recalls are due to errors in product labelling or
packaging artwork. Therefore, it makes sense
to ensure labelling technology is a priority, so it
can address any inconsistencies in processes,
mitigate human errors, enhance label quality and
improve business agility in order for the company
to produce compliant, high-quality labels in a cost
and time-efficient manner.
Typical pharma labelling challenges
Traditionally, pharmaceutical companies have
purchased label printers locally, on a plant
and country level.  This has resulted in many
fragmented and disparate label software and
printing solutions within the same organisation.  It also solves the challenge of a fragmented
This fragmented landscape is further complicated
by the fact that plants often use separate printing
systems for labelling and direct marking tasks.
Add to this the need to comply with market and
country specific labelling requirements, and the
result is a label database containing thousands
of label variants.
Creating multiple label templates across multiple
systems in various regions is a costly and laborious
process, even when that process is digitised.
The more manual the procedure, the higher the
likelihood for errors.
A fragmented labelling environment also makes
it challenging to process label change requests
in a timely, efficient manner. This can cause many
issues, especially when regulations in some
markets, such as FDA CFR 21, require documenting
every change in the system, including new and
updated label templates.
A modern label management system can address
these issues. By centralising and digitising labelling,
pharmaceutical companies can create an efficient,
streamlined process for producing accurate,
compliant labels.
Benefits of a modern label management system
A modern label management system digitises
the entire label management process, from label
design to printing and management. It includes a
centralised, digital label catalogue that controls
and streamlines label lifecycle management. It
eliminates the need for paper-based catalogues
and prevents the creation of data silos.
11
By introducing role-based access, configurable
approval workflows, and document versioning and
electronic signatures, a modern label management
system helps prevent unauthorised label changes
and provides the necessary documentation to
comply with regulatory requirements. It includes
label variant technology that can help pharma
companies drastically reduce the number of label
templates they have to maintain.   
A modern label management system can also be
integrated with Manufacturing Execution Software
(MES) and Enterprise Resource Planning (ERP)
systems. This integration provides a single source
of the truth for label data. 
label printer landscape by introducing universal
templates that work across all label and direct
marking printers. This means pharma companies
get one, centralised labelling system that can
guarantee correct labels regardless of the printer
make, brand or location.
How pharma companies benefit from modern label
management
An example of how pharma companies can benefit
from implementing a modern label management
system can be seen in the case of Boehringer
Ingelheim. It has been able to implement a global,
standardised labelling process with digital quality
control and ERP integration. This has enabled
Boehringer Ingelheim to eliminate its manual quality
control procedures and institute a centralised way
of updating label information, therefore processing
change requests more quickly than before.   
A solution for now and the future
Going forward agility, accuracy and compliance will
be key to pharmaceutical companies competing
successfully in a very challenging marketplace.
A modern label management system is a vital
component in achieving this; however, the benefits
don’t end there. By putting the right system in
place now, and removing inefficiencies from their
labelling process, pharma companies will have
a solid foundation for manufacturing process
improvement. And they will also be in a far better
position to address future regulatory changes, such
as serialisation. With the right framework in place,
pharma companies will be well positioned to meet
current, and future, challenges.
12

AN INSIDE LOOK
at Norgine
Peter Stein
CEO, Norgine In June this year, European pharmaceutical company Norgine held a 50-year
anniversary for its global manufacturing site in Hengoed, Wales. Following the event,
European Pharmaceutical Manufacturer editor Reece Armstrong caught up with
Norgine’s CEO Peter Stein to discuss pharma trends, US and EU drug approvals
and the company’s approach to improvement.

S tein begins by explaining the

roots of the Hengoed site -
its 50-year history born from small
beginnings with a team of around
20 employees. Now, the site is
responsible for producing over
30 million packs of medicine every
year, a fact recognised at the event
as well as the ‘unique position
Hengoed has in Wales as a major
manufacturer for the world,’
according to Stein.
Norgine itself has a rich history.
A family owned business founded
in the early 1900s, Norgine was
the first company in central Europe
to start manufacturing insulin but
fell dormant in World War II until it
was eventually revived by Walter
Stein after the war.
Norgine serves markets in the
US and Japan but Stein explains
that what the company has really
done is build a European platform
‘that’s able to develop, register,
manufacture and market products
on a European scale’.
During Stein’s time in the industry,
the biggest change he’s seen
‘is the extent to which the industry
is much less fragmented by
national markets and standards
and it’s more focused on regional
or global standards’. Indeed, it’s
these harmonised standards
– introduced by the European
Commission in 2008 to help
companies market products in the
EU and European Economic Area
- that Stein believes has enabled
Norgine’s success in Europe.

Another area Stein is keen

to emphasise is just how
differentiated new therapies
need to be if they are to really add
value to patients and healthcare
systems. In fact, what quickly
becomes evident during our chat
is just how advantageous Stein
believes the EU healthcare system
to be compared to that of the
United States’.

Originally from the US himself,

Stein’s time in Europe has
really made him appreciate
the European system.

“It’s a good thing that the industry

is obliged to focus on products

that actually add value and actually
change patient care and actually
deserve to be added to medical
practice,” he says. This focus on
‘added-value products’ ensures
companies focus their R&D effort
‘towards things that are going to
make a difference,’ Stein adds.
But perhaps the major advantage
for manufacturers is the
immediate access they gain to
the EU marketplace once they
receive reimbursement. While
this benefits patients through the
access they get to medicines, the
United States’ system of private
healthcare still leads to patients
being unable to afford medicines,
even though they’re still
technically available.
But while the EU certainly
holds many benefits for both
pharmaceutical manufacturers
and patients, the conversation is
quickly derailed by Brexit and the
uncertainty it presents.
For Norgine, its priority has been
in ensuring patients will always be
able to access its medicines,
Stein iterates.
“Continuity of supply has been
first and foremost in our thinking.
We’ve been preparing for it [Brexit]
since 2016. Unfortunately it’s
costing a lot of money, it’s costing
a lot of time but I think we are in
a position that we will be able to
make sure our patients continue
to receive our products in
any scenario.”
Not wanting to get caught up in
the complexities of Brexit we move
on to talk about Norgine’s base in
Wales and the country’s perhaps
under-recognised contribution to
pharma.
“I think it’s one of the things that
deserves more attention. Wales is
actually a fantastic place to locate
www.epmmagazine.com
13
a life science company. You have
academic institutions that are very AN
INSIDE
strong and that can form highly
trained workforces,” Stein says.
That workforce, Stein adds, has
L
helped drive Norgine through
a culture that is dedicated to
learning and developing.
When questioned on the potential
of workers being left behind by the
introduction of new technologies,
Stein has absolute admiration for
the way Norgine’s workforce
have upskilled.
“The shop floor employee of 20,
30 years ago would not be able to
cope with the technology they’re
using today and almost universally
people have embraced it because
it is essential
for the future
of the site.”
K
Moving on,
Norgine sees itself
focusing on two
avenues of growth
which will help bolster
its European base and
also bring medicines
over from the US into the
European market. So for the
UK and in particular Wales,
Norgine’s success is bolstering
the Welsh life sciences industry
and bringing attention to an area
which in Stein’s view, deserves
more recognition.
The shop floor employee of 20, 30 years
ago would not be able to cope with
the technology they’re using today
and almost universally people have
embraced it because it is essential for
the future of the site.
14
Unsure who to trust?
Biocidal products manufactured in or imported into the European Union (EU) must be
authorised for compliance with the requirements of the EU Biocidal Products Regulation
(BPR) and any relevant national legislation before being placed on the market.
Here, Karen Rossington and Siobhan Murphy from Contec guide readers through
the implications on life science cleanroom users.
B iocidal products have been
regulated in the EU by the
EU Biocidal Product Regulation
528/2012 (BPR) since
Karen Rossington 1 September 2013.
and Siobhan Murphy
from Contec The aim of the BPR is to improve
the consistency of the biocidal
products available in the EU and
ensure a high level of protection
for humans and the environment
via a two-stage process of active
substance approval followed by
biocidal product authorisation. The
provisions of the BPR set out to
harmonise the market at EU level
and simplify the approval of active
substances and authorisation of
biocidal products. The BPR acts
directly in all EU Member States,
meaning that local legislation
does not need to be created to
implement the requirements.
BIOCIDAL PRODUCT DEFINITION
Article 3 of the BPR defines
a biocidal product as, “any
substance or mixture, in the form
in which it is supplied to the
user, consisting of, containing or
generating one or more active
substances, with the intention of
destroying, rendering harmless,
preventing the action of, or
otherwise exerting a controlling
effect on any harmful organisms
by any means other than mere
physical or mechanical action.”
If the intended use of a wipe
pre-saturated with 70% IPA is for
surface disinfection, even if the
manufacturer makes no biocidal
efficacy claims, the product is
classified as a biocidal product
according to the BPR.
COVER STORY
BIOCIDAL PRODUCT
AUTHORISATION PROCESS
There are two consecutive steps
required to gain EU BPR biocidal
product authorisation:
1. The active substance(s) in
the biocidal product must be
approved under the appropriate
product-type. This process
takes place at EU-level.
2. Each biocidal product
containing or generating the
approved active substance(s)
must then be authorised under
the appropriate product type
at industry level.
When active substances are
approved, they are listed in EU
BPR Article 9: Approved List of
Active Substances (Union List).
The EU BPR consists of four
product groups including 22
different biocidal product
types covering: disinfectants,
preservatives, pest control and
specialty biocides. The group
relevant to life science cleanroom
users is Main Group 1: Disinfectants
and PT2: — disinfectants and
algaecides not intended for direct
application to humans or animals.
This includes products used for the
disinfection of surfaces, materials
and equipment, which do not
come into contact with food
When a disinfectant has been
authorised under one product-
type it cannot be used in another
product-type unless authorisation
is also granted for the second
product-type.
ARTICLE 95 OF THE BPR
As well as the approval process
described above, from 1 September
2015, Article 95 of the BPR has
applied to active substances
placed on the EU market, either on
their own or in biocidal products.
Biocidal products cannot be made
available on the EU market unless
the active substance is sourced
from an approved supplier on the
so-called Article 95 list maintained
by the European Chemicals
Agency (ECHA).
For example, if a wipe containing
70% IPA is imported from a
manufacturer outside of the
EU, either the active substance
supplier, the product manufacturer
or the EU importer must be listed
on Article 95. If none of the
above are listed on Article 95,
the product cannot be sold legally
in the EU as a biocidal product.
KEEPING TRACK OF THE BPR
The active substance approval
process is ongoing and is
gradually replacing national
regulations. Each biocidal active
substance is at a different stage
in the regulatory process and
keeping track of the status of the
active substances in your biocidal
products is critical to ensure
continuity of supply.
Biocidal products, which are not
going through the authorisation
process can no longer be placed
on the market from 180 days after
the date of approval of the active
substance, and they can no longer
be used from 365 days after
the date of approval. Where the

biocidal product contains more
than one active substance, the
relevant phase- out periods begin
on the date of approval of the final
active substance to be approved,
or not-approved.
An unauthorised biocidal product
discovered by regulators could
immediately be withdrawn from
the market leaving the end user
without a validated disinfectant.
As a worst-case scenario, product
manufacture could be delayed
whilst a replacement disinfectant
undergoes months of validation.
Any company about to start,
or whom has an on-going
disinfectant validation project
needs to ensure that the biocidal
product under investigation is
already, or is intended to be,
authorised under the EU BPR
by the manufacturer or importer.
The costs associated with the
EU BPR will most likely lead
to a contraction in the market,
specifically in the number of
biocidal products available.
The costs to approve active
substances and authorise biocidal
products are significant. The
costs to gain approval of an active
substance can be several million
euros and a simple disinfectant
product could potentially
cost €750k to €1m
to authorise.
www.epmmagazine.com
There is currently no definitive list of authorised disinfectant products and the BPR active substance
approval process is expected to still take several more years before completion. However, biocidal
product users can do the following:
1. List all products being
used for microbial control
(these might be products
not currently supplied with
efficacy claims such as IPA
presaturated wipes). Review
the SDS for these products
and note the ingredients.
If unsure, confirm with
the supplier the active
microbiocidal ingredients in
the formulation.
2. Find out the suppliers of
each active substance in
the disinfectant formulation.
Ask the supplier to provide
details of the active
substance manufacturer’s
inclusion on the ECHA
Article 95 list. The Article
95 list is available online
(https:// echa.europa.eu/
information- on-chemicals/
active-substance- suppliers).
3. Ensure the active substance
is listed under the correct
product-type for its use.
Although a listing of these products
is not currently publicly available,
cleanroom operators should ask
their disinfectant supplier about
the process followed for submitting
the dossiers.
STEP BY STEP
4. If the active substance
has been approved
and is listed on the
Union list of approved
active substances, then
a manufacturer of an
existing biocidal product
has approximately two
years to submit a dossier
for either National or
Union Authorisation of
the formulation. The list of
currently approved active
substances can be checked
online via https://echa.
europa.eu/information-on-
chemicals/ biocidal-active- 6. The list of currently
substances.
5. For common disinfectant
actives used in
cleanrooms, such as
IPA, PAA, hypochlorites
and hydrogen peroxide,
the actives have already
been approved and the
deadlines for submission
of product authorisation
This will uncover any lack of
knowledge of the authorisation
process and will also give the
end-user the opportunity to ensure
their uses of the product, and
usage areas, are included in
the authorisation application.
The manufacturer should
also confirm whether they are
submitting a dossier for a Union
Authorisation (all countries) or a
National Authorisation, which may
or may not be followed by Mutual
Recognition applications.
If a lack of knowledge of the BPR
from a manufacturer’s standpoint
is apparent, cleanroom operators
should start a revalidation plan to
ensure continuity of a legal supply
from a different manufacturer.
15
dossiers have passed.
Any products for which a
dossier was not submitted
by the relevant deadline
must remain off the EU
market until authorisation is
granted; after the phase-
out periods.
a. Propan-2-ol (70% IPA)
Deadline 1 July 2016
b. Hydrogen Peroxide
Deadline 1 Feb 2017
c. Active chlorine/
Hypochlorites
Deadline 1 Jan 2019
approved active substances
and upcoming deadlines
can be checked online
via https://echa.europa.
eu/regulations/ biocidal-
products-regulation/
authorisation-of-
biocidal- products/union-
authorisation/ -union-
authorisation- applications.
The aim of
the BPR is to
improve the
consistency
of the biocidal
products
available
in the EU.
16
Smarter, Faster, Better –
The Next Frontier
Dr Ramin Rafiei
Director of
Digital Healthcare,
SHL Group
In Drug Delivery
At the confluence of Moore’s law and Metcalfe’s law the next frontier in drug delivery
becomes data-driven, personalised and outcome-based.
O ver the past few decades, the
cost of bringing new drugs to
market has been doubling every
nine years. This exponential trend,
measured as the number of FDA
approvals per billion USD spent
on R&D, is known as the Moore’s
law of the pharmaceutical industry
and labelled Eroom’s law1 – Moore
spelt backwards. Compounding
this diminishing return on
pharmaceutical R&D investments
is the gap between clinical efficacy
of medications as determined
in a randomised controlled trial
(RCT) setting and their real-world
effectiveness.
Medication adherence is the
key factor for the gap between
RCT efficacy and real-world
effectiveness as typically 50% of
patients with chronic conditions
fail to take the recommended
therapeutic dose consistently,
resulting in poor health outcomes
and increased healthcare costs2.
As a result, solely relying on the
clinical efficacy of new medications
REFERENCES
1 Vinay Kini, P Michael Ho, “Interventions to improve medication 4 Shubham Singhal and Stephanie Carlton, “The era of
adherence”. JAMA, 2018; Vol 320(23), pp 2461-2473.
2 Thomas Forissier and Katrina Firlik, MD, “Estimated
Pharmaceutical Revenue Loss Due to Medication 5 Rich Karlgaard, “Ten Laws of The Modern World”. Forbes, 2005
Nonadherence”. Health Prize and Capgemini Consulting, 2012.
3 Thomas Forissier and Katrina Firlik, MD, “Estimated
Pharmaceutical Revenue Loss Due to Medication
Nonadherence”. Health Prize and Capgemini Consulting, 2012.
DIGITAL HEALTH
is not the solution to chronic
disease management; rather, we
need to find ways to help patients
self-manage existing conditions.
This also presents pharmaceutical
companies with a $600 billion-plus
opportunity, which is otherwise lost
revenue due to medication non-
adherence3.
Moore’s law, attributed to co-
founder of Intel Gordon Moore,
has transformed computing
through exponentially decreased
costs and increased performance.
There are already a number of
examples across the healthcare
industry where the impact of
Moore’s law has resulted in
exponential change, such as the
cost of genome sequencing,
adoption of DNA testing and
utilisation of telehealth services4.
As technology continues to get
smaller, lighter, more efficient and
intuitive, computers and sensors
are also making their way into
drug delivery devices. Today,
connected injectable therapies
exponential improvement in healthcare?” McKinsey Insights,
2019
are still in their infancy when
compared to respiratory and
oral therapies. However, studies
across these three therapeutic
categories have consistently
demonstrated that when drugs
are augmented through sensors
and connectivity, patient
adherence and health outcomes
improve. So could the application
of Moore’s Law to drug delivery
be the solution to medication
non-adherence?
Adherence is multifactorial
and stems from the diversity of
patient behaviours and barriers.
Connected drug delivery devices,
which measure dose-level (true)
adherence in real-time, are the
necessary first step towards a
solution. However, improvements
in adherence can only be realised
when real-world data (RWD) from
connected devices is applied
effectively towards supporting
patients with self-managing
their condition outside the
clinic setting.

The first application is behavioural
support by targeting and tailoring
interventions designed to change
behaviour and improve patient
adherence to therapy. RWD
from connected devices create
a feedback loop by providing
a mechanism to learn which
interventions are most effective.
Today machine learning models
are being applied to deliver
interventions, measure the effect
of each intervention on the target
behaviour, and improve the
accuracy of the next intervention
based on real-time adherence
data. Dose-level adherence data
also enhances remote treatment
support, in which the data is used to
improve clinical treatment decisions,
and support ongoing dose titration
until the optimal treatment regimen
for each patient is reached.
www.epmmagazine.com
17
Metcalfe’s law, proposed by
Robert Metcalfe the inventor of
Ethernet, states that the value of
a network grows exponentially as
a function of network size5. When
RWD is actively used to improve
the patient experience, increase
their engagement with their care
plan, and improve adherence to
therapy, Metcalfe’s Law predicts its
value will grow exponentially for
all stakeholders across the care
continuum. For pharmaceutical Solely relying on the
companies, this benefit will best
manifest itself in an ability to clinical efficacy of new
measure and improve the real- medications is not the
world effectiveness of drugs.
This next frontier in drug delivery
solution to chronic disease
combines Moore’s and Metcalfe’s management; rather,
laws to become data-driven, we need to find ways to
personalised, outcome-based, and
accessible. This next frontier is help patients self-manage
connected therapeutics (CTx). existing conditions.”
18 DIGITAL HEALTH – SPONSORED FEATURE

UNLOCKING THE VALUE

IN CONNECTED HEALTH
Kevin Deane
Vice-president, Connected health offers promising potential for pharmaceutical companies and drug delivery
Innovation, device developers and manufacturers to create a more positive patient experience that can
Phillips-Medisize
help improve medication adherence and facilitate better outcomes. However, only a few
connected health solutions tied directly to medication have made it to market so far,
even as healthcare becomes increasingly digital.

Filling the Data Void The Connected Health The Benefits

As healthcare systems worldwide
start to implement outcome-based
reimbursement, the ability to
measure medication effectiveness
– and patient adherence – plays
an even more important role in
managing and improving patient
health. Unfortunately, little actual
data exists that pinpoints when,
or even if, patients take their
medication, despite new prescription
drug development costs estimated
to be as high as $2.6 billion1. A range
of research has demonstrated,
though, that adherence rates are
typically lower for patients with
chronic conditions, and even clinical
trials report average adherence rates
of only 43 to 78%2. Poor medication
adherence is also the cause of 33
to 69% of all medication-related
hospital admissions in the United
States alone.2
Integrating connectivity into
innovatively designed, patient-
centric drug delivery devices can
REFERENCES
help fill this data void and support
1 Sullivan, Thomas.
increased adherence by making
A Tough Road: Cost to it easier and simpler for people to
Develop One New Drug take their medication on-time and
is $2.6 Billion; Approval
Rate for Drugs Entering as prescribed. Connectivity provides
Clinical Development is an efficient way to monitor patients’
Less Than 12%. Policy &
Medicine. March 21, 2019.
adherence and condition, as well
2 Osterberg L, Blaschke as to share both real-time and
T. Adherence to historical data with patients, clinical
medication. N Engl
J Med. 2005 Aug
researchers, healthcare providers,
4;353(5):487-497. caregivers and payers.
Ecosystem
The connected health ecosystem
includes three primary
components: connected devices,
such as inhalers and injectors;
digital interfaces, including
patient and caregiver apps,
and dashboards for healthcare
professionals; and a cloud
platform, enabling data integration
with multiple sources including
diagnostic devices, IoT sensors
and EHRs in order to generate
insightful analytics.
Four years ago, Phillips-Medisize
developed the first connected
health system registered with the
FDA for a specific drug. Since
then, the number and popularity
of connected health pilots has
grown, but pharmaceutical
companies sometimes struggle
with how to scale the model,
and extract and quantify the
value created, which can impede
additional investment.
Recognising the increased
interest and demonstrable
benefits that connected systems
provide, Phillips-Medisize decided
to invest in developing a highly
scalable platform to service the
expanding market, rather than
developing and maintaining one-
off, application-specific solutions
for each new project.
The resulting cloud-based
connected health platform provides
a scalable medical device data
system (MDDS) for pharmaceutical
companies and drug delivery
device developers. By reducing
the risk, time and cost associated
with developing connected health
solutions, it helps accelerate time
to market.
Additional benefits include:
• Comprehensive information-
sharing and analytics capabilities.
It connects pharma companies,
clinical researchers, providers,
patients and payers, sharing
and displaying information from
connected drug delivery devices,
biosensors and regulated Mobile
Medical Applications (SaMD/
MMA). Dashboards can be
customised quickly and easily at
any point, which saves time and
money, adds high-value flexibility
and streamlines connection
with other supported external
analytic systems. It also integrates
medication, diagnostic and
therapeutic data from multiple
sources as well as supports global
comparisons by normalising data
across geographies.
• Robust cybersecurity. A connected
health platform can be deployed in a
secure private cloud with a credible
legacy of health data security, in a
cloud hosting option selected by
 www.epmmagazine.com
19

the pharmaceutical company, or in current drug injection device in order • Personalised, localised messages
the company’s own data centre. In to retain existing patients and attract and reminders for patients on their
addition, cost-effective and secure new ones. The company's drug had device and in the app
collaborative environments are established safety and efficacy, but
available for situations where cross- its injection device lagged in user The integrated system was
industry partners want the ability to friendliness. The company sought introduced in countries worldwide
share data. to use electronics to improve the after its initial launch in Europe.
• Streamlined regulatory injection experience but also wanted It has made injections more
documentation. Full regulatory to help patients better manage intuitive for patients, made it easier
documentation services included their disease by offering seamless for caregivers and healthcare
with the connected health platform integration between the device providers to coordinate and follow
support premarket submissions and a patient app that could track up on treatment, and helped the
for 510(K), combination products injections and remind patients when company retain its market position.
and CE mark to help lower project and where to take them.
costs and speed time to clinical Meeting Market Needs
trial, regulatory approval and Teaming with Phillips-Medisize,
market – ahead of the competition. they developed and manufactured The pace of development continues
an innovative electromechanical to accelerate as pharmaceutical
• Modular approach. Working with
autoinjector connected to the companies and drug device
a manufacturing partner who
cloud, featuring: developers and manufacturers
can deliver connected health
• Ergonomic design operated with seek to meet market needs. The
solutions that incorporate devices
one hand opportunity to develop innovative
with embedded electronics
connected health solutions using
and sensors also speeds the • Secondary control functions
a secure cloud-based platform
development process and keeps hidden on the inside
that provides a safe and scalable
costs low, for both reusable and • A dashboard for healthcare MDDS helps reduce risk, cost and
disposable drug delivery devices. professionals to easily monitor time to market. At the same time, by
Connected health platforms patients demonstrating a clear pathway to
that come with a software
• Bluetooth connectivity that ensures value creation, these cost models
development toolkit and defined,
data on injection time, volume and can bridge the gap between pilot and
extensible API allow any device
body location are synced with the program and encourage additional
to be connected to the system.
patient app and dashboard investment in connected health.
Pairing a configurable app with
the connected health platform
and deploying it across multiple
products using a standard
Bluetooth interface further
supports a rapid, low-cost path to
clinical trial and market.
• Massive scalability. Building on a
flexible, scalable platform rather
than starting from scratch for
each new drug makes it highly
cost efficient to add or refine
infrastructure for future projects.
Because the price per user
declines as the patient population
increases, the costs for integrating
connectivity for medications
used to treat common chronic
conditions also decrease.

A Case Study

A leading pharmaceutical company

recognised the need to update its
20
ALTERNATIVE APPROACHES
TO PHARMA INNOVATION
Tyler Golato Scientific Lead at Molecule
T he cost of drug development
has increased steadily and
significantly over the past 40 years.
In the 1970s, a drug could be
brought to market for approximately
$54 million in the United States.
Today, estimates for the cost of
bringing a single drug to market
range from $800m - $2.5b.
Patent protection and market
exclusivity attempt to incentivise
the shouldering of this cost by
providing the opportunity for a
return on investment. However,
while patent protections are often
a key focus for pharmaceutical
companies in terms of their
business strategy, they are
problematic for collaborative
research. Patents are closed source
and monopolistic by nature.
Increasingly, the business
model for drug discovery and
development is predicated
on recouping costs barely
manageable for first-world,
affluent nations. In an effort
to combat this trend, various
stakeholders in the drug discovery
ecosystem - academia, industry,
foundations, governments, and
regulators - have been identifying
and exploring novel models based
on collaboration and distribution
of risk that provide new schemes
for incentivising and rewarding
drug discovery.
However, no breakthrough model
has yet led to transformative
change in the industry, and patents
are still the primary means of
ensuring exclusivity over new drugs
that are brought to market. This
has had severe consequences on
innovation: industry is increasingly
moving away from research in
ANALYSIS
riskier areas and revenue has
become the primary driver of
research efforts. 
is achieved by providing the
infrastructure for individual markets
to be established around a single
piece of IP (e.g. a patent), similar
Despite these challenges, a new to the way markets exist for shares
generation of projects, such as OSP, in specific companies. This model
M4K, and Molecule, have emerged distributes risk and cost, thereby
which are attempting to rethink the allowing smaller organisations,
current pharma business model. such as universities, to collaborate
One model that shows promise for with other institutions via shared
creating sustainable change in the ownership models to research
industry is that of fractionalising IP and develop therapeutics.
ownership. This entails the creation It effectively lowers the barrier
of an open, multi-sided marketplace of entry to drug development,
for drug development with a allowing stakeholders that have
platform for IP creators to generate been priced out of traditional
public markets for new drugs and drug development practices
therapeutics to attract funding. to participate and compete. 
At its core, systems such as these This shift toward a more
can use curation markets and transparent, open, and
crowd-intelligence to discover collaborative future for drug
valuable therapeutics and direct development is similar to what
resources towards them. The open source did for software. As
underlying asset of each market is innovation continues to decline in
a patent, or combination thereof, the pharmaceutical industry, open
and shares in individual markets source models could prove useful
represent ownership rights. The in reversing the trend.
overarching goal is to create
incentives for a more open source
R&D process that will bring down
costs, accelerate development,
bring more diverse treatments to
market, and move stakeholders
towards collaboration: new
business models for the current
broken pharma industry. 
These types of platforms can
also generate novel funding
opportunities for parties with an
interest in drug development.
For example, organisations can
access funding and liquidity from
underutilised IP, or alternatively,
distribute ownership in IP currently
under development to garner
funding and further their projects.
This fractionalised IP distribution
 @makingpharmamilano
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22
Dr Shawn Conway
Engineering R&D
Director of Cambrex
REFERENCES
1 Kevin P. Cole Kilogram-
scale prexasertib
monolactate monohydrate
synthesis under
continuous-flow cGMP
conditions, Science 16
Jun 2017: Vol. 356, Issue
6343, pp. 1144-1150; http://
science.sciencemag.org/
content/356/6343/1144.long
SINGLE USE
Go with the flow
The rising trend of continuous flow is bringing economic and safety benefits
to manufacturers, says Dr Shawn Conway.
T he economic and safety
benefits of implementing
continuous flow retrospectively
on a commercial scale for a single
process step are widely known
and have been well documented,
with the replacement of traditional
batch-based manufacturing
by continuous flow chemistry
continuing apace. Many major
pharmaceutical corporations,
including Lilly, GSK and Novartis,
are actively investigating and
investing significant sums in the use
of continuous flow.
There is also an emerging use of
continuous flow processes in early
clinical development, where the
need is to manufacture enough
of a drug compound so that the
development process can begin.  processing time. This scale up can
Introducing continuous flow at this
point enables the use of specific
types of reactions that are very
difficult to accommodate with the
traditional batch process. This means
that a compound can typically
be obtained in a quicker, cleaner
manner; it also makes it possible to
start building a process that can be
commercially viable from the outset,
reducing the potential multiple
iterations of a development cycle
as the compound progresses from
phase to phase.
The ability to optimise the process
from the outset is a major advantage
as it means that the best route can
be used, rather than one best suited
to a batch operation. Commercial
scale batch processing imposes
limitations in terms of the types of
equipment that may be available
and the processes that could be
used. With continuous flow, all
routes can be explored to find the
most appropriate synthesis that can
then be progressed through all the
different stages of development.
In general, continuous flow
offers a process that is scalable
from the beginning, allowing the
manufacture of a few hundred
grams or perhaps a kilogram
of a compound, and this can
be quickly increased to larger
quantities of material for a later
phase, by increasing the scale of
the equipment, or by extending the
be done multiple times through to
commercial quantities, as opposed
to batch manufacturing, where
process optimisation would have to
be carried out each time production
is scaled up.
Applying continuous flow in early
phase development also allows
greater control over the reaction.
A batch reaction can introduce
significant variations within the
vessel that can lead to incomplete
conversion, side reactions and
degradation, whereas with
continuous flow, parameters such
as residence time, temperatures,
pressures, concentration and
pH, can all be tightly controlled
resulting in a high degree of
consistency. Avoiding these
impurities gives a more streamlined
process that is easier to take on to
subsequent phases.
Similarly, the increased monitoring
of the process and the ability to
take samples in real time increases
the understanding of what is
happening during the synthesis.
Monitoring the process across
a range of time points creates a
much better picture of the reaction
compared with leaving a batch to
process for 12 or 16 hours and then
sampling the result. 
Although cost savings cannot
be quantified precisely, making
an intermediate sized batch of
product could be in the region
of hundreds of thousands of
dollars, so any technology that can
streamline this process and reduce
or remove this spend is obviously
advantageous. Furthermore,
reducing the development timeline
and shortening the development
phases can mean that a compound
reaches the market faster, bringing
forward the time when a drug gets
to the patient and the company
starts to make a return on its
investment.
There is increasing demand for
drug substances with higher
potencies which require, smaller
doses and therefore, potentially
smaller manufacturing campaigns.
Smaller volume batches can
be relatively expensive using

traditional batch production,
due largely to the overhead
costs of the facility, so lend
themselves well to continuous flow
technology where capital costs
tend to be much lower. Rather
than converting a batch process
into a continuous flow-based
analogue, exploring flow synthesis
in the early development stages
allows for the subsequent steps
to be streamlined, saving time
and money in the long run, as
previously noted.
Multiple process steps in flow,
such as reactions, work-up,
extractions, crystallisations
and distillations with different
equipment requirements can be
developed and connected in a
small footprint facility as opposed
to over several large assets in
a production facility with the
associated handling challenges
and costs.
Eli Lilly's highly potent oncology
drug Prexasertib demonstrates
the practice of employing
continuous flow in early
phase development, where
the technology was adopted
for the final four steps of the
synthesis1 throughout clinical
www.epmmagazine.com
scale manufacture, and now on
to commercial production at a
rate of three kilograms a day.
Specific challenges that needed
to be addressed, that have been
published and discussed, included
the use of hydrazine at elevated
reaction conditions to drive
purity and performance, as well
as avoiding issues surrounding
isolation and handling of potent
toxic intermediates. Concurrent
analytical monitoring also enabled
rapid trouble-shooting during the
manufacturing process.
The recognised benefits of this
process were numerous and
allowed eight continuous operations
to take place in series, within small
continuous reactors, extractors,
evaporators, crystallisers and filters.
A continuous reactor type was
developed and utilised, as was
a method for in-process filtration
and redissolution. The process
included the ability to operate at
high temperature in a low-boiling
solvent, afforded improved safety
for a hazardous reaction, better
23
With continuous flow, all routes
can be explored to find the most
appropriate synthesis that can
then be progressed through all the
different stages of development.
yield and an improved impurity
profile. The containment of highly
potent materials was achieved
through the use of dedicated
and disposable equipment; and
synthetic efficiencies were seen
with enhanced product stability, the
elimination of one isolation step, and
the elimination of solids handling in
another isolation step.
The advantages described above
and illustrated in the example
from Eli Lilly demonstrate that
continuous flow drastically
minimises, if not eliminates, safety
and quality complications that
arise from inhomogeneity and it
should therefore be regarded as
a truly enabling technology and a
powerful development tool.
24
ACHIEVING THE PERFE
Marcus Knöll, who holds a Ph.D. in pharmacy and heads Bosch Packaging Technology’s Pharma
Service Solid, has been supporting customers in all development and production phases of solid
dosage forms for the past 12 years. And he knows exactly what they need for a fast time-to-
market: efficiency, quality and extensive experience in formulation development.
WHAT ARE YOUR CUSTOMERS’
MAIN CONCERNS?
The pharmaceutical industry
is dominated by a high cost
pressure. This is not only true for
production; it already starts in
the development phase. A fast
introduction of new products, in
other words a fast time-to-market,
is essential. Pharmaceutical
manufacturers cannot afford any
delays; competitors will overtake
them. However, efficiency is not
everything. At the end of the
day, product quality also has to
measure up.
WHAT CHANGES CREATED THIS
COST PRESSURE?
For instance in Germany, the
drug prescription process has
changed fundamentally. In the
past, doctors simply wrote the
name of a given manufacturer’s
product on the prescription,
patients bought it at the pharmacy
– and some producers made a
lot of money. Later, pharmacists
were obligated to offer a product
from the bottom third of the
price range. Today, it’s all up to
the health insurance companies.
They conclude agreements with
one or more manufacturers for
short time frames. This puts the
manufacturers under enormous
pressure to keep the unit price
as low as possible, so they are
IN PROFILE
rewarded the contract. We can see
similar trends in various markets –
either in calls for tenders, or other
price-dropping mechanisms like
state-dictated price caps.
WHAT IS THE GREATEST
CHALLENGE FOR
MANUFACTURERS?
For generics manufacturers, the
hurdle – besides price and time
pressures – is bioequivalence
studies, in which the generic must
demonstrate the same effect as
the original medication. If the
study fails, it means the company
not only wasted a great deal of
money, but also roughly a year
of development time. The key
to minimising the risk of failure
is extensive experience and
know-how. That’s precisely what
we offer our customers as a
partner. Every year, we conduct
roughly 1,000 experiments with
substances for various indications
at our development centre in
Schopfheim. Our customers, in
turn, benefit from the insights from
these tests.
Of course, some of the tests are a
dead end. But mistakes don’t have
to be repeated. This experience
helped us develop products like
Tamsolusin and Venlafaxin, rapidly
and at affordable prices. We can
also rely on our global network
and contacts to universities and
higher education institutions to
incorporate the latest findings,
as well as the lessons learned by
partners like excipient suppliers.
All these aspects improve our
chances of success.
WHAT ARE THE MOST
IMPORTANT PREREQUISITES
FOR SUCCESSFUL
DEVELOPMENT?
All pharmaceutical disciplines
must be closely interlinked. We
offer customers everything from
a single source: from formulation
and analytical development, to
stability tests and bioequivalence
studies. Plus, we recently added
another important aspect: dossier
preparation. We support our
customers from start to finish,
which saves them a great deal of
time and energy. We particularly
focus on technology transfer,
which means developing a
product that our customers can
then manufacture on their own
equipment. That is our scale-up
guarantee.
HOW DOES THE BOSCH
OFFER DIFFER FROM THAT OF
CONTRACT MANUFACTURERS?
The aim of our service is to help
customers help themselves.
Bosch Packaging Technology has
a long mechanical engineering
 www.epmmagazine.com
25

ECT FORMULA

tradition. However, we have The challenge is to not only

continuously expanded our generate machine data, but
expertise beyond the machine. to precisely analyse that data
We share this pharmaceutical and draw the right conclusions.
expertise with our customers, We combine our equipment,
for example in seminars where processing, pharmaceutical and
they can learn about topics like software know-how with data
granulation and coating. mining to gain valuable insights
that help us optimise production
WHAT OTHER CHALLENGES DO processes.
CUSTOMERS COME TO YOU
WITH?
Many customers are familiar
with small-scale production but
struggle with scale-up to larger
volumes. This often requires large
investments and bares some risks.
With our NextStep software, we The key to minimising the
offer concrete support in just one
day. In addition, many customers
risk of failure is extensive
are now considering a switch experience and know-how.
to continuous manufacturing.
Dr Marcus Knöll Bosch Packaging Technology
We have our own continuous
manufacturing platform, Xelum.
But we can also design their
manufacturing process so
they can switch to continuous
manufacturing at a later point in
time. And of course, many of our
customers are thinking about
digitisation but don’t know how to
get started with low budget.

WHICH FIRST STEPS TOWARD

INDUSTRY 4.0 WOULD YOU
RECOMMEND?
In many cases, even older systems
offer enough data for analyses.
 for medical devices, pharmaceutical manufacturing and digital health.
Keep up to date with key developments that matter.
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 PROCESS EQUIPMENT
A buyer’s guide to
process equipment
Rachel Morgan Rachel Morgan from the Adelphi Group of Companies provides an insight into what buyers
Adelphi Group of
Companies need to look for when purchasing process equipment.
W ith all the furore in the UK
and beyond surrounding
the ‘B’ word, companies in the
pharmaceutical industry are
looking to the future with an
increasingly concerned eye.
From start-ups to multi-national
corporations, businesses need
their process equipment to stand
the test of time. Investing once and
investing right takes the weight
off peoples’ minds, leaving them
free to grapple with the wider
challenges facing their business.
“So how can I make sure
I shop smart?”
It sounds like the oldest mistake
in the book, but don’t buy the
cheapest process equipment you
come across! Purchasing cheaper
or plastic process vessels and
equipment can become false
economy in the long run, as
such alternatives are largely less
hygienic and less durable. They
can also be susceptible to rusting,
pitting and corrosion.
It sounds For the pharmaceutical
manufacturing industry, process
like the equipment needs to have been
oldest created with a specific eye for
hygiene. Look for products with
mistake in a pit and crevice-free design, to
the book, avoid potential bug traps. 316
medical grade stainless steel is the
but don’t apex, but you need to make certain
buy the sure that if you ask for 316, that’s
cheapest what you get. We hear all sorts of
horror stories about vessels being
process delivered to a medical production
equipment environment which are entirely
316… apart from the base, or apart
you come from the lid! Save yourself the
across! hassle; companies who provide
27
material traceability and testing
certification should shoot to the
top of your supplier list, as they
is over or they become irreparably
damaged, stainless steel items
should never enter the waste
are guaranteeing the quality of the stream. Stainless steel is 100%
goods you receive. At PHP, our recyclable and can be reused to
X-ray analyser confirms the metal make new products without loss
alloy makeup of your process of any of the original properties,
equipment, while our Surface such as tensile strength, ductility
Finish Analyser checks out surface and corrosion-resistance. On
smoothness, ensuring that those average, most stainless steel
unhygienic nasties have nowhere items are made of approximately
to hide. 60% recycled material, with 25%
of that derived from end-of-life
Another major factor to consider products, and the other 35% from
when searching for the quality manufacturing processes.
you need, is the challenges
presented by an increased focus
on sustainability. ‘Environmental
footprint’ has gone from a
secondary to a primary concern,
and businesses are coming
under pressure to show that
they are willing to invest in
making environmentally aware
improvements. This is one concern
which shows no sign of abating
(indeed, it looks be exponentially
increasing), so when looking to
future-proof your business, your
process equipment is a great
place to start.
“Stainless steel is one of the
most environmentally efficient
raw materials available”, states
Life Without Plastics, “because
of its durability and ability to
be recycled”. Over the past
twenty years, improved process
technology has enabled
manufacturers to significantly
reduce the quantities of energy
required to produce stainless steel.
Stainless steel products should
last significantly longer than their
plastic counterparts under normal
usage. Even once their service life
28 SPONSORED WHITEPAPER
Why deep freeze?
The storage of high-quality
biopharmaceuticals is a major
challenge for the industry. Proteins
are easily affected by changes
in ambient conditions and react
sensitively to changes in their
environment. The complex three-
dimensional protein structure is held
together by weak, intra-molecular
interactions and is therefore
particularly delicate. The native
folding of protein substances is
essential for their efficacy: only if a
protein is correctly folded will the
right molecules be bound. Changes
in the structure will have fatal
consequences; in certain cases,
they do not only result in a loss
of efficacy, but may even cause
pathological effects.
This means the process of storing an
active protein substance must be the
result of an exceptionally careful and
sophisticated design process and all
influencing factors must be known
since the substance will often need
to be stored for years.
The pharmaceutical industry has
found deep-freezing to be a stable
method of storing protein solutions.
The active ingredient is cooled in
freezing chambers or in controlled
All Photographs: F&T
freezing containers until the whole
Services ©ZETA. bulk solution has reached the required
F&T -70°
temperature level. However, we know
from practice that rearrangements and
structural effects will occur in proteins
even in the frozen state, which can
also result in changes to their native
structure. Damaging alterations
may, for example, lead to increased
aggregate formation or flocculation. In
order to preserve the product quality,
freezing at very low temperatures
is required. A change in the protein
structure is to be prevented by
choosing temperatures below the
glass transition temperature.
The change in product quality
and the various freezing effects
depend on the one hand on the
process parameters selected, and
on the other hand they are strongly
influenced by the composition of
the protein solution. In most cases,
quality changes caused by the
effects described above will entail
additional process steps and drug
losses. Product loss must in any case
be reduced to a minimum. Identifying
the relationships between the
composition of the protein solution,
concentration, pH value, additives,
cryo-protectors or additives and the
behaviour of the quality of the protein
solution after one or more freeze and
thaw cycles is the basis for advanced
understanding of the F&T process.
More risk management, less
product loss
The frozen protein solution becomes
increasingly concentrated as ice
crystals form during freezing. The
auxiliary substances, such as buffer
salts, gradually lose their effect
depending on their solubility. The
pH value of a sodium phosphate
buffer can, for example, drop from
7.0 to below 4.0 during freezing.
The ionic strength can also increase
significantly. In addition to that, the
formation of ice crystals leads to an
ice-liquid interface which can impact
protein folding. The influencing
parameters and their effects differ
widely for each substance. This is
why they are examined for each
product individually in the lab, using
tailor-made F&T equipment. The
aim is to understand the product
behaviour in one freeze and thaw
cycle in order to be able to derive
optimum process understanding
from this knowledge.
Once the basic behaviour of the
protein solution during freezing
has been understood, the F&T
processes developed in the lab
will be scaled to pilot scale. The
freezing process is analysed,
optimised further and precisely
defined. The specified process is
the basis for industrial processing
and thus an important element
in the development of optimum
storage of the protein substance.
The pilot scale allows for various
analytical methods and represents
a valuable intermediary scale. The
most suitable process parameters for
the product need to be determined
and optimised. Contrary to initial,
business driven assumptions this
does not necessarily have to be
the speed of freezing, because one
thing is for sure in the F&T process:
quality takes precedence over
efficiency. As explained above, the
PilotFreeze examines the processes
that were previously developed in
the laboratory to prepare them on a
larger scale for industrial processing.
Practical applications have shown
that the PilotFreeze can also be
used to verify existing industrial
F&T processes. The processes are
then checked again and optimised
in the course of optimisation or
retrospective process validation
before they are fed back to industrial
production by means of a technology
transfer. In summary we can say the
PilotFreeze analysis is as important
for the process development of
new protein solutions as it is for the
optimisation of current processes.

Does deep-freezing guarantee
optimum product quality?
Only at temperatures below the
glass transition temperature can it be
assumed that there will be no more
movements and structural changes
in the structure of the proteins in
solution. Consequently, a temperature
of below -70°C was defined as a
prerequisite for the freezing system
for particularly sensitive products.
While freezing containers on an
industrial scale of up to 500 l are
already established practice for
an industrial freezing process
in the moderate temperature
range, the large-scale solution
for freezing highly sensitive and
active pharmaceutical proteins in
a low temperature range of <-70°C
needed a new development. The
first 200 l freezing container for
freezing down to -85°C emerged in
a cooperation project, which was
yet another result from the many
years of cooperation between ZETA
and Boehringer Ingelheim in the
field of freezing processes.
In a series of tests with the proven
ZETA PilotFreeze, the freeze and thaw
processes were investigated and the
effects on product quality in the form
of aggregation, fragment formation,
turbidity or particle formation were
analysed. The efficiency of the
process was the prime objective
of designing the vessel geometry.
Important parameters for this
were the consideration of product
throughput, achievable temperatures,
the geometric conditions in the
tank and the ice layer thicknesses
achieved. Calculations for achievable
cooling and thawing rates were
carried out and later verified by
means of experiments.
The development of the new vessel
included some major challenges for
the ZETA engineering team; they had
to find materials suited for the low
temperature range that would allow a
stable and safe freezing process and
withstand long storage time. Another
important criterion for the right choice
of material was personal safety.
www.epmmagazine.com
29
This special requirement is owed
to the product itself, which as a
About ZETA:
highly active drug calls for special
precautions in worker protection.
With a staff of more than 500
people and its headquarters
Theoretical calculations on freezing
in Lieboch/Austria and nine
rates were empirically confirmed in
subsidiaries in Europe,
the test series. These results enabled
the ZETA Group is one of
BI to develop a concrete calculation
the biggest suppliers of
model, which is the central
engineering, automation
element of a scientific publication
and process technology for
commissioned by BI.
biopharmaceutical applications.
The product range includes
high-tech equipment, pilot
plants and turnkey industrial
plants for the biotechnological
production of pharmaceutical
substances. ZETA is your
expert in the development of
customised process solutions
along the entire development
and production process for
aseptic applications, from
laboratory to industrial scale.
The ZETA facility in Lebring,
Southern Styria, develops
and builds products that
support ZETA customers along
the process of producing
pharmaceutical agents.
ZETA is specialised in the
Together with the freezing systems,
development, enhancement
which serve the different process
and improvement of mixing
volumes, ZETA covers the entire
technologies and freeze & thaw
development process of a freezing
systems. The solution experts
unit – from the product investigations
of the ZETA R&D department
to the freezing plant on an industrial
develop innovative products
scale. Professional project teams take
and patent them together
the current stage of every project
with their customers and in
product into account. In this way,
cooperation with research
the mutual knowledge gain can be
centres and universities.
maximised through cooperation,
the product quality can be maintained
in the best possible way and the time
to implement processes and set up
plants can be accelerated in
an optimum manner.
Birgit Pittermann, Head of R&D at
ZETA, sums it up: "From ZETA's point
of view, the success in developing
freezers for very low temperatures is
due to the joint efforts made by both CONTACT:
cooperation partners." Birgit Pittermann, Daniela Eustacchio
Head of R&D ZETA Marketing Specialist – Team Leader
birgit.pittermann@zeta.com Daniela.eustacchio@zeta.com
30 PROCESS EQUIPMENT
TIME IS MONEY
The legacy that single-use pumps are leaving on processing systems.
Dr Andreas Frerix
T
Product Manager
for Quattroflow oday’s most common
Fluid Systems biopharmaceutical-
manufacturing systems require the
handling, transferring, processing
and purification of large-molecule
drugs produced in living organism-
like animal-cell cultures, bacterial
cells or yeast. This must be done
in a liquid phase with the handling
of these materials performed
by pump technologies that
can reliably provide volumetric
consistency and accuracy,
pressures and flow rates, and low-
pulsation, which are required in the
process, and low-shear, low-heat
input and material compatibility
that protects the biological drug
from being harmed.
Traditionally, multiple-use
(cleanable) stainless-steel pumping
and processing systems have
been used for these operations,
but the time and cost needed
to operate, clean, maintain and
quality control the system before
the next production run could
commence became prohibitive.
That led to a true innovation for
the industry, the creation of single-
use systems including pumps that
feature a disposable pump head
and chamber that can be easily
removed and replaced between
production runs, eliminating the
time and cost needed for cleaning
validation the equipment in a
stainless-steel system.
While single-use pumps have
been an undoubted boon to
biopharmaceutical manufacturers
– with positive displacement
quaternary (four-piston)
diaphragm pumps becoming
a go-to technology choice for
many manufacturers – there
were still improvements that
could be made in optimising their
changeover times and simplifying
the installation process. A
breakthrough in this area came in
2017 with the development of a
pump-chamber replacing system
that reduces the time needed to
replace a disposable single-use
pump chamber to mere seconds.
KNOW YOUR UNIT OPERATIONS
The foundation of
biopharmaceutical manufacturing
rests on various types of unit
operations. While each unit
operation features its own set of
operational criteria, they are alike in
that they can only produce a viable,
contaminant-free biological drug
suitable for human administration
if the manufacturer strictly adheres
to an unbending set of operational
parameters and structures.
Some of the most common unit
operations in biopharmaceutical
manufacturing include tangential
flow filtration (TFF), column
chromatography and virus filtration.
The common thread between
these various types of unit
operations is their need for and use
of a pumping technology that can
satisfy their specific operational
parameters. Again, these unit
operations are processes in
which the quaternary diaphragm
pump excels, while competitive
technologies, such as peristaltic
(hose), lobe, centrifugal and piston
pumps, may struggle to meet a
series of strict product-handling
and -transfer requirements.
THE SINGLE-USE SOLUTION
Some additional mention must
also be given to the advantages
that utilising single-use
quaternary diaphragm pumps in
biopharmaceutical manufacturing
can deliver. The main advantage
for these pumps – whether used
in traditional stainless-steel or
single-use setups – are their
unique form of operation: The four
quaternary diaphragms are driven
one after another by a connector
plate, which moves back and
forth out of its central position in a
stroke generated by an eccentric
shaft, with the length of the stroke
determined by the angle of the
eccentricity. The four pumping
chambers, which actually operate
in the same way the human heart
does, keep the product flow
constantly moving forward in a
volumetrically consistent low-shear
and low-pulse manner.
The pump’s chambers also contain
no rotating parts that can be
subject to friction, meaning that
there is minimum heat buildup that
can compromise the product. This
mode of operation means that
the pumps can run dry, are self-
priming, and produce low shear
because of minimal slip. In addition,
they offer low-pulsation, leak-free
operation while having great dry/
wet suction-lift capabilities.
This turndown capability and
range for quaternary diaphragm
pumps is also unique in the
biopharmaceutical industry. As the
products go from development
to clinical trials and then to
commercialisation, proper scaleup

is essential. In other words, the
same pump in a lab may need
to handle flow rates as low as
1/2-ounce per minute while also
being able to deliver commercial
production flow rates of 50 gallons
per minute or more.
The quaternary diaphragm pump
is also easily adaptable to single-
use production configurations.
A single-use pump enables
biopharmaceutical manufacturers
to essentially eliminate the
oftentimes-prohibitive cost of
validating the cleaning of their
pumps and systems. The result is
a quicker and more cost-effective
production process and one that
still delivers preferred levels of
product purity and safety with no
chance for cross-batch or cross-
product contamination.
The fulcrum of the single-use
pump is its product-wetted plastic
pump chamber that can be
replaced as a complete unit.
THE NEXT STEP FORWARD
So, now we arrive at the next step
in the evolution of the single-use
quaternary diaphragm pump
used in unit operations within
biopharmaceutical manufacturing.
While single-use pump technology
conquered the question of how to
reduce time and costs for cleaning
after production runs, there was still
more ground that could be plowed
in the realm of reducing the time
needed for pump-head replacement.
The breakthrough came last year
with the development and release
of a pump-chamber replacing
system which essentially eliminates
downtime in the production-
changeover process. This allows
manufacturers to replace a single-
use pump chamber in 30 seconds
or less without the need of torque
wrenches, or other special tools
and equipment. Pump-chamber
replacing systems can also be
www.epmmagazine.com
31
retrofitted on existing motor drives,
which also makes upgrades quick
and easy to perform.
Many skills are needed to
CONCLUSION produce biopharmaceuticals, but
Many skills are needed to produce
biopharmaceuticals, but in the
in the end the final product must
end the final product must be one be one that is unquestionably
that is unquestionably safe to use safe to use while simultaneously
while simultaneously allowing the
manufacturer to reap the financial allowing the manufacturer to
benefits of a limited patent window. reap the financial benefits of a
The arrival of single-use pumps on
the scene has virtually eliminated
limited patent window.
the cost and downtime that were
previously required to validate the
cleaning efficiency of pumping
systems. A further leap ahead has
been taken, however, with the
creation of the pump-chamber
replacing system, an innovation that
will continue to optimise time, cost,
reliability and safety capabilities
in the biopharmaceutical-
manufacturing industry.
£
£
£
£
£
£
£
£
£
£ £ £
£
£
£
32
Light it up
Why the storage and access of chromatography data is vital to pharmaceutical
Patrick Kenny manufacturing chains.
Product marketing
specialist, Thermo
Fisher Scientific
A nalytical workflows underpin
many of the most essential
processes in the pharmaceutical
manufacturing chain, from
the analysis of raw materials
and final products, through
to method development and
validation checks. These
workflows often involve gas
or liquid chromatography
techniques, coupled to robust
detection methods such as mass
spectrometry, which generate
large volumes of data.
Organising, accessing and sharing
the complex information generated
by chromatography workflows
can be challenging, particularly
if production and quality control
(QC) teams are located across
multiple locations. With regulatory
authorities putting increased focus
on the accuracy, consistency and
completeness of pharmaceutical
manufacturing data, these
workflows must be managed in
a way that not only maximises
operational efficiency and provides
space to innovate, but supports
full regulatory compliance
too. As a consequence, many
pharmaceutical organisations are
re-evaluating the systems and
methods they use to manage and
control their chromatography data.
Modern pharmaceutical
manufacturing chains are
highly integrated and inherently
dependent upon the free flow of
information between teams. To
ensure the release of safe, high-
quality products, decision-makers
need timely access to reliable and
consistent QC data they can trust.
DATA
Maintaining the integrity of
production line data has long
been a priority for pharmaceutical
manufacturers. However,
regulatory bodies such as
the United States Food and
Drug Administration (US FDA),
European Medicines Agency, and
UK Medicines and Healthcare
products Regulatory Agency
(MHRA) are now tightening their
guidance to safeguard data
integrity at every stage of the
pharmaceutical pipeline. This
includes manufacturing, product
testing and packaging steps, and
all require robust solutions for
managing workflow information.
For organisations with production
lines working across multiple
territories and continents, keeping
track of chromatography data
while maintaining its integrity in
line with regulatory guidelines
isn’t always straightforward.
Pharmaceutical manufacturing
footprints have expanded
considerably in recent years:
teams may be located in different
buildings, sites or even countries.
While dispersed manufacturing
chains can result in reduced
operational costs and shorter times
for products reaching end-users,
they can unintentionally lead to
poorly harmonised processes and
inconsistencies in data.  allow users to download
These issues are further
compounded if fragmented
approaches to managing and
controlling chromatography data
are used. Workflows that employ
partially paper-based systems to
store chromatograms, method
parameters and calibration checks,
or use separate spreadsheet
software to process and report
results, can be vulnerable to
errors, requiring time-consuming
validation and checking steps to
mitigate these issues.
With seamless information
exchange key to achieving the
highest standards of data integrity
and operational efficiency,
pharmaceutical manufacturers
therefore need effective solutions
for chromatography data
management that bring their
workflows, instruments and
users together. 
Many pharmaceutical
manufacturers now recognise
the challenges associated with
fragmented chromatography
workflows and are adopting CDS
software solutions that integrate
their workflows to centralise the
storage of data and harmonise
processes company-wide.
Among the many benefits of
organising chromatography
workflow information centrally,
one of the most important
is in terms of improved data
consistency. With standard
operating procedures stored
centrally, modern CDS solutions
parameters and method details
to instruments directly, reducing
the need for manual processes,
minimising the potential for human
error, and ensuring the same
practices are followed across
the organisation. Some CDS
solutions take this a step further

and incorporate sophisticated
algorithms that can perform user-
defined tasks such as dilutions
or reinjections to obtain high-
quality chromatograms first time
around. Advanced systems, such
as Thermo Scientific Chromeleon
CDS Software, can even automate
the integration of chromatogram
peaks, further enhancing the
consistency and reliability of data.
Storing chromatography
information centrally can also
help teams work more efficiently
by maintaining a single version
of the data, eliminating the
inconsistencies that can be
introduced if multiple versions
of files are used. CDS solutions
that facilitate centralised
storage also allow data to be
securely accessed by colleagues
wherever they are, allowing
them, for instance, to initiate and
check on sequences remotely.
With easy access to the latest
chromatography data at the
click of a button, results can be
shared faster, helping teams make
decisions around manufacturing
and batch release more quickly
and, ultimately, accelerating the
delivery of therapeutics.
The increased complexity
and footprint of modern
pharmaceutical manufacturing
processes means regulators are
putting an increased focus on
the traceability and transparency
of the data associated with
chromatography workflows.
Regulations such as U.S. FDA
Title 21 CFR Part 11 and UK MHRA
‘GXP’ Data Integrity Guidance and
Definitions require pharmaceutical
manufacturers to ensure
traceability from measurement to
reporting. For large organisations
with multiple moving parts,
maintaining full accountability
across the manufacturing chain
can be challenging; demonstrating
compliance in the event of an
audit even more so.
www.epmmagazine.com
33
The latest CDS software solutions
make it straightforward for
pharmaceutical manufacturers
to achieve end-to-end oversight
of chromatography workflows
and avoid the complexities
associated with harmonising
audit trail information when
fragmented solutions are used.
Most CDS solutions will store a
complete history of interactions
with the system. However, some
of the more advanced CDS
solutions offer powerful audit
trail functionality to enable users
to quickly and easily search and
review events in order to help
detect unusual or non-compliant
user behaviour. Some platforms,
like Chromeleon CDS, allow all
events to be easily key-word
searched and filtered based on
action, and even allow audit trails
to be added to reports for review.
With the right tools to support
complete workflow transparency
right across the manufacturing
chain, businesses can reduce
time searching and focus more
on innovation.
Chromatography workflows play
a central role in pharmaceutical
production processes and
manufacturers need effective
solutions that make managing,
accessing and sharing this
information between teams
seamless, secure and regulatory-
compliant. The latest CDS
software solutions are helping to
maintain the highest standards
of data integrity to help the
pharmaceutical industry
accelerate the manufacture
of safe and effective medicines
for patients.
While dispersed manufacturing
chains can result in reduced
operational costs and shorter times
for products reaching end-users,
they can unintentionally lead to
poorly harmonised processes
and inconsistencies in data.
34
5 FACTORY DEVELOPMENTS
Catalent breaks ground
on new facility
Catalent has broken ground
on a new $112 million drug
product manufacturing facility
in Indiana. The site will increase
the company’s fill/finish capacity
in Bloomington and will house
a range of technologies to
support production. Catalent
Biologics will create up to
200 new jobs to support the
increased production. The
new facility is expected to be
completed by the end of 2024.
Production of anti-cancer
drugs boosted by new
cleanroom
Production of new anti-cancer
drugs at ADC’s Bio North Wales
manufacturing facility has been
boosted by a new cleanroom,
designed and built by WHP.
The new facility supports
the production of antibody
drug conjugates through
a stringently controlled
environment, eliminating
any risks during antibody
modification and conjugation.
FROM THE FACTORY
A key feature of the
development by WHP was
to install a bespoke low
maintenance toxic waste
system to remove cleanroom
waste to a holding tank,
where it is transported to
an off-site incinerator. The
system incorporates dry break
couplers to seal off both ends
of the pipeline to prevent
the possibility of any onsite
contamination.
Wasdell commences
operations in Dundalk
The Wasdell Group has
commenced operations at its
EU headquarters after receiving
its Manufacturer’s/Importation
Authorisation licence (MIA) from
the Health Products Regulatory
Authority (HPRA).
The new headquarters is
located at the IDA Technology &
Science Park in Dundalk, Ireland
and is thought to be the fastest
custom-built site to achieve
cGMP approval.
Vincent Dunne, CEO said:
“This is another significant
milestone for Wasdell, and I am
extremely proud of our team
and the efforts made to open
this facility.”
GSK dedicated to Singapore
to advance technologies
GSK has opened a new
$130 million manufacturing
facility in Jurong as part of a
company roadmap dedicated
to developing advanced
technologies in Singapore.
The investment comes as
part of the GSK-Economic
Development Board 10-year
Singapore Manufacturing
Roadmap. GSK has expanded
one of the production buildings
on its Jurong site in an effort to
accelerate the supply of new
medicines to patients.
Mr Chng Kai Fong, managing
director, Singapore Economic
Development Board said:
“Over the years, GSK has
continually partnered with
Singapore to develop
advanced manufacturing
technologies, such as
continuous manufacturing
and digital manufacturing.
They have also been a strong
partner in training our local
talent. These efforts have
supported the growth of the
industry as a whole and in
turn has created diverse and
attractive job opportunities
for Singapore.”
Onyx Scientific to expand
UK facility
Onyx Scientific has strategically
invested in its UK facility to
position the company for a
commercial API license.
The investment is driven by a
growing demand for flexible,
specialist and small-scale API
manufacture. The company
will expand its UK facility to
put in place the infrastructure
to manage and commercialise
customer projects.
Onyx is working with the
Medicines and Healthcare
Products Regulatory Agency
(MHRA) and is expecting
licence approval later this year.
 Pharma Packaging
and Labelling
Europe 2019
10th & 11th September 2019, Munich, Germany
Following a successful comeb ack to Europe last year, we are delighted to present
stimulating discussions and presentations devised to tackle recent regulatory challenges
and explore innovations within packaging and labelling within the pharma and device
industry. Experts from all over Europe will gather in one room across two days for close
knit networking, open deb ates and interviews.

Key Speakers 2019 Key Highlights 2019

• Gideon Brunner, Senior Global • Analysing the EU MOR and its implications
Packaging Engineer, Roche for Labelling and Artwork

• Dr Robert Wenzel, Director Of • E-Labelling: accessing digital information from a

Labelling & Translation, Fresenius packaging barcode using a standardised
Medical Care approach

• Paulina Onzaga, Associate Director • Minimizing the confusion and clarifying the
Supply Chain, Allergan future of FMD for packaging and label design

• Yves Steffen, Head Packaging & • Improving artwork change implementation

Device Commercialisation BTDM, across supply chain, tools and stakeholders
Novartis and interactions across functions

• Jette Byg, Head Of Regulatory • Regulation on MOR & IVDR: Deadlines

Affairs Support, Coloplast approaching, are you complaint to the
regulation?

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m ev.ents@atieri1a-internatiori1al.com
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