SUPPLEMENT TO THE MARCH 2015 ISSUE OF MARCH 2015
EUROPEAN
OUTSOURCING
OUTLOOK
2015
ES582894_PTESUPP0315_CV1.pgs 03.11.2015 20:10 ADV blackyellowmagentacyan
For further information call:
[+34] 935 710 100 www.partnership.grifols.com
Your strategic CDMO for pre-mixed intravenous sterile solutions
in flexible bags and glass vials
You can place
your trust in our hands
Small volume glass vials
Available sizes:
from 5 to 50ml
6228 Anunci Grifols Partnership.indd 1 3/3/15 14:32
ES582809_PTESUPP0315_CV2_FP.pgs 03.11.2015 18:01 ADV blackyellowmagentacyan
outsourcing market
s4 Trouble on the Horizon for the Expanding Contract Manufacturing Market?
Faiz Kermani
capacity expansions
s10 CMOs Plan for Capacity Expansions
Eric Langer
outsourcing trends
s12 Moving with the Changing Tides of Outsourcing
An Industry Roundtable Moderated by Adeline Siew, PhD
technology transfer
s18 Technology Transfer: A Practical Science
A.G. Damodhar
sterile solutions
s22 Sterile Solutions: How to Choose the Right CDMO?
Marga Viñes
s24 Guide to Conventional and
Biotech Pharmaceutical Outsourcing Services
s26 Ad Index
European Outsourcing Outlook 2015
Issue Editor: Adeline Siew, PhD
On the Cover: David Coder/Sylvain Sonnet/Getty Images; Dan Ward
PharmTech EuropeEditorAdeline Siew, [email protected]
PharmTech GroupEditorial DirectorRita [email protected]
Senior EditorAgnes [email protected]
Managing EditorSusan Haigney [email protected]
Manufacturing EditorJennifer [email protected]
Science EditorRandi [email protected]
Community EditorAshley [email protected]
Contributing Editor
Cynthia A. Challener, PhD
Global Correspondents
Jane Wan
(Asia, [email protected])
Sean Milmo
(Europe, [email protected])
Hellen Berger
(Latin and South America,
Art Director
Dan Ward
Publisher
Michael Tracey
Associate Publisher
Chris Lawson
Tel. +44 1244 629 324
Senior Sales Executive
Stephen Cleland
Tel. +44 1244 629 311
Published byUBM AdvanstarHoneycomb West,Chester Business Park,Wrexham Road,Chester, CH4 9QH, United KingdomTel. +44 1244 629 300Fax +44 1244 678 008
UBM Advanstar:Chief Executive OfficerJoe Loggia
Executive Vice-President, Life SciencesTom Ehardt
Executive Vice-PresidentGeorgiann DeCenzo
Executive Vice-PresidentChris DeMoulin
Executive Vice-President, Business SystemsRebecca Evangelou
Executive Vice-President, Human ResourcesJulie Molleston
Executive Vice-President, Strategy & Business DevelopmentMike Alic
Sr Vice-PresidentTracy Harris
Vice-President, General Manager Pharm/Science GroupDave Esola
Vice-President, LegalMichael Bernstein
Vice-President, Media OperationsFrancis Heid
Vice-President, Treasurer & ControllerAdele Hartwick
UBM Americas:Chief Executive OfficerSally Shankland
Chief Operating OfficerBrian Field
Chief Financial OfficerMargaret Kohler
UBM PLC:Chief Executive OfficerTim Cobbold
Group Operations DirectorAndrew Crow
Chief Financial OfficerRobert Gray
ChairmanDame Helen Alexander
Published by
10% PostConsumer
Waste
Editorial: All submissions will be handled with reasonable care, but the publisher assumes no responsibility for safety of
artwork, photographs, or manuscripts. Every precaution is taken to ensure accuracy, but the publisher cannot accept
responsibility for the accuracy of information supplied herein or for any opinion expressed.
Subscriptions: Pharmaceutical Technology Europe is free to qualified subscribers in Europe.To apply for a free subscription, or to change your name or address, go to PharmTech.com, click on Subscribe, & follow
the prompts.
To cancel your subscription or to order back issues, please email your request to [email protected], putting PTE
in the subject line.
Please quote your subscription number if you have it.
List Rental: Contact Sarah Darcy; Tel. +44 1244 629 326 Fax +44 1244 659 321
Reprints: Reprints of all articles in this issue and past issues are available (500 minimum).
Contact Brian Kolb at Wright’s Media, 2407 Timberloch Place, The Woodlands, TX 77380. Telephone: 877-652-5295
ext. 121. Email: [email protected].
Copyright 2015. Advanstar Communications (UK) Ltd. All rights reserved.
No part of this publication may be reproduced in any material form (including photocopying or storing it in any medium
by electronic means and whether or not transiently or incidentally to some other use of this publication) without
the written permission of the copyright owner except in accordance with the provisions of the Copyright, Designs &
Patents Act (UK) 1988 or under the terms of a licence issued by the Copyright Licensing Agency, 90 Tottenham Court
Road, London W1P 0LP, UK.
Applications for the copyright owner’s permission to reproduce any part
of this publication should be forwarded in writing to Permissions Dept,
Honeycomb West, Chester Business Park, Wrexham Road, Chester, CH4 9QH.
Warning: The doing of an unauthorized act in relation to a copyright work
may result in both a civil claim for damages and criminal prosecution.
ES582686_PTESUPP0315_003.pgs 03.11.2015 02:20 ADV blackyellowmagentacyan
Da
vid
Co
de
r/S
ylv
ain
So
nn
ett
/Ge
tty
Ima
ge
s; D
an
Wa
rd
Pharmaceutical companies use outsourcing as a strategic option for
manufacturing (1, 2), and this trend has been growing for a number
of years, driven mainly by the potential opportunity for companies
to reduce costs. Globalization of the pharmaceutical industry has
resulted in outsourcing options becoming more international in
nature. Today, contract manufacturing organizations (CMO) exist in a
number of different countries and work on behalf of clients in other
parts of the world.
Perspectives on the sector outlookWith the economy faltering and companies struggling financially, cost
minimization is often the main influencer in outsourcing decisions.
However, concerns about quality standards and adherence to regulations
have led many stakeholders to worry that other important aspects
relating to outsourcing are being overlooked. All organizations involved
in the manufacture of pharmaceuticals should comply with good
manufacturing practice (GMP) standards, which were originally developed
to ensure that medicinal products are consistently produced and
controlled to the quality standards appropriate to their intended use and
as required by the marketing authorization or product specification (3).
Incidences of GMP violations, however, have been identified during
routine inspections by regulatory agencies, demonstrating that not all
manufacturing sites operate with the same standards. EudraGMDP,
the EU database that contains GMP certificates (4, 5), lists details of
such violations identified by European regulators. Consequently, both
regulators and industry associations have been working to determine
the optimal way to ensure sufficient monitoring of the global contract
manufacturing system and supply network.
According to an annual pharmaceutical sector survey by Nice
Insights, the total CMO market was valued at US$33.7 billion in
Faiz Kermani
The market for outsourcing is set for growth, but the pharmaceutical
industry has concerns over product quality and continuity of supply,
especially with CMOs in emerging markets.
Trouble on the Horizon for the
Expanding Contract Manufacturing Market?
2014 (6). Overall, most industry
observers predict that the market
for outsourced pharmaceutical
manufacturing is set for continued
growth in the future (7). This is a
logical projection given that the global
market for pharmaceutical products
is growing, hence driving the need
for organizations with specialized
capabilities to manufacture these
products. Furthermore, it is unlikely
that companies that have already
outsourced their manufacturing
activities would have financial
resources to bring back those
functions in-house (which in any case,
would be a hugely time-consuming
exercise).
Nevertheless, it appears that the
CMO industry has suffered in the
current difficult financial climate,
with a number of players exiting
the sector. Difficulties in complying
with increasing regulations
and manufacturing capacity
constraints have also played a part
(8). Consequently, this situation
has caused some difficulties for
companies in seeking alternative
manufacturers with the capabilities
to continue production of their
drugs (8). Due to these factors, it is
recommended that companies pay
closer attention to the agreements
they set up with CMOs and employ
risk management elements to
proactively address any possibility
that their CMOs may exit the sector.
Based on answers from more
than 2300 respondents, the Nice
Insights annual survey (6) provides
considerable insight into the
industry’s current attitudes to
outsourcing of pharmaceutical
manufacturing activities. While the
survey findings indicate a positive
future for CMOs, they also highlight
areas of vulnerability that could
unsettle the sector’s rate of growth.
Of those questioned, more than
half intended to outsource solid-
dosage manufacturing, 50% of
respondents would outsource for
injectables, 44% for semi-solids,
and 42% for speciality dosage
forms. In terms of CMOs of choice,
most companies were interested in
seeking service providers in emerging
markets; however, it appears that
providers in the established markets
are still set to receive considerable
s4 Pharmaceutical Technology Europe EuropEan outsourcing outlook 2015 PharmTech.com
ES582621_PTESUPP0315_004.pgs 03.11.2015 01:39 ADV blackyellowmagentacyan
DRAW ON
EXPERTISE
If you had the opportunity to draw your ideal CMO, we’re
confdent your vision would look like AbbVie Contract
Manufacturing. Partner with us, and you can beneft from
experience and knowledge refecting a century at the forefront
of pharmaceutical development and manufacturing, and some
of today’s biggest drug success stories. We also bring a modern,
agile approach, resulting in a relationship aligned with your
vision, with commitment to your science.
Advance your project quickly and reliably.
Contact AbbVie at +1 847 938 8524 or visit
www.abbviecontractmfg.com
The prior Proprietary Pharmaceuticals business of Abbott Laboratories is now AbbVie.
Biologics | Potent | Drug Product | Fermentation
Preflled Syringe | Hot Melt Extrusion | APIs
ABBVIE CONTRACT MANUFACTURING
ES582810_PTESUPP0315_005_FP.pgs 03.11.2015 18:00 ADV blackyellowmagentacyan
Outsourcing Market
opportunities. For the outsourcing
of solid dosage manufacturing, 23%
of respondents were considering
options in the United States and
Canada and 15% were looking to
European organizations (6).
What is intriguing about the sector
survey is that although emerging
market providers were top of the
list as outsourcing prospects,
pharmaceutical companies admitted
to having certain reservations about
their quality levels, adherence to
appropriate regulatory standards, and
protection of intellectual property
rights (6). Concerns over these
quality and compliance aspects have
tainted the CMO sector in emerging
markets in recent years, and given
that manufacturing is closely linked to
the pharmaceutical supply network
in major markets, any disruption at
the manufacturing end can have
a significant impact downstream
in the supply chain. Despite this
unease, respondents in the survey
acknowledged that outsourcing
to emerging markets has reduced
their costs; as a result, they are still
prepared to pursue this strategy.
Violations of manufacturing standardsRecently, Ranbaxy’s manufacturing
sites in India have been the subject
of negative media coverage (9–11).
Following an unannounced United
States FDA inspection to Ranbaxy’s
Toansa site in January 2014, the
agency reported severe failures
in complying with pharmaceutical
current GMP and prohibited the
site from producing and distributing
drugs for the US market (9, 10). The
GMP violations reported by FDA
included Toansa staff retesting raw
materials, intermediate drug products,
and finished API after those items
had failed analytical testing and
specifications, in order to generate
acceptable findings, and subsequently
not reporting or investigating these
failures (9). The agency required
Ranbaxy to hire a third-party expert
to thoroughly inspect its facility and
certify to FDA that the site and its
methods and controls were adequate
to ensure continuous compliance with
current GMP (10).
Unusually, European regulators
took a different approach to the
Ranbaxy situation. After the FDA
inspection, European regulators sent
a team of inspectors from Germany,
Ireland, and the United Kingdom,
who were also joined by inspectors
from Switzerland and Australia (10).
Following this separate assessment
of the site, EMA reported that “there
was no evidence that any medicines
on the EU market that have an API
manufactured in Toansa were of
unacceptable quality or presented a
risk to the health of patients taking
them.” EMA also stated that the
Ranbaxy site would be kept under
close supervision in collaboration
with Indian and other international
regulatory authorities (10).
The different approaches taken
by the US and European regulators
have been criticized in the media.
FDA has stated that similar quality
standards and underlying principles
of current GMPs were used by both
sets of regulators, but that differing
regulatory and legal standards
were used to address the violations
identified (10). While EU authorities
have reinstated Ranbaxy’s GMP
certificate (4), FDA declined to
overturn its ban until Ranbaxy met its
requirements (10).
At the end of 2014, European
authorities were forced to take action
against Ranbaxy over its antibiotic
product, cephalosporin, after German
regulators found that its plant in
central India was not complying with
standard manufacturing practices
(11). Specifically, the inspectors found
deficiencies concerning operation
of drug manufacturing rooms and
procedures related to sterilization of
equipment. As a result, the product
was banned from being imported into
the EU (11).
The Ranbaxy incidents are not
the only bad publicity for the Indian
pharmaceutical manufacturing sector
that are grabbing headlines (12, 13).
In 2014, a paper was published by
researchers who claimed that a
number of Indian drug manufacturers
were making substandard drugs for
global markets where there was weak
or non-existent regulatory monitoring
(14). The researchers analyzed the
quality of 1470 drug samples from
Indian manufacturers that were sold
in Africa, India, and five mid-income
non-African countries (14). Of these,
nearly 11% failed a basic assessment
of APIs, and most of the failures were
due to substandard products (7%)
that contained some correct APIs but
with the amount of the API under-
dosed (14).
In the light of these manufacturing
issues, the US appears to be taking
a stronger stand compared to the
EU authorities. Given that Indian
pharmaceutical manufacturers
supply 40% of over-the-counter and
generic prescription drugs on the US
market, FDA has been under public
pressure to take action against any
lapses in quality and safety (13). In
2014, FDA inspected 160 Indian drug
plants, which was three times as
many as in 2009 (13). Furthermore,
safety standards for Indian-
manufactured products were among
the topics discussed between FDA
Commissioner Margaret Hamburg and
Indian trade minister Anand Sharma
when they met in February 2014 (12).
Besides India, China is another
country that is often cited for
violations in pharmaceutical
manufacturing (13, 15–17). EMA
data from the EudraGMDP database
revealed that in 2013, 10 Chinese
manufacturing plants and 14
Indian plants failed to comply with
required standards (15). In October
2014, EU GMP inspectors from the
competent authority in Romania
found 26 deficiencies at the Chinese
API manufacturer, Hebei Dongfeng
Pharmaceuticals (16). The customers
of the Chinese company included
firms in Spain, Italy, the Czech
Republic, and Cyprus amongst other
countries (16). European companies
were subsequently prohibited from
using the APIs concerned (16). In
November 2014, German inspectors
identified one critical, non-major and
several minor deficiencies to EU GMP
at the Chinese API manufacturer,
Zhejiang Apeloa Kangyu Bio-
Pharmaceutical Co. Ltd (5, 17).
While much of the media focus
concerning GMP violations centres
on manufacturing sites in emerging
markets, the EudraGMDP contains
records of incidents in Europe as
well (5). In November 2014, Spanish
inspectors issued a GMP non-
compliance report for local company
Manuel Riesgo and identified 32
failings (5, 17). The company, which
s6 Pharmaceutical Technology Europe EuropEan outsourcing outlook 2015 PharmTech.com
ES582626_PTESUPP0315_006.pgs 03.11.2015 01:39 ADV blackyellowmagentacyan
Outsourcing Market
repacks APIs, was found to lack
laboratory facilities and, therefore,
could not ensure that APIs complied
with the established standards of
quality and purity (5, 17). In fact,
the inspectors found that no tests
to verify batches of the material
were ever conducted and that the
original manufacturers were never
evaluated nor approved (17). Around
the same time, Austrian authorities
reported 11 GMP violations, including
eight major ones, at the domestic
company Agepha (5). Among its
failings, the company was unable
to prove that all relevant analytical
methods had been validated by its
quality-control department and
inappropriate reference materials
had been used (5).
Improving inspectionsThe pharmaceutical industry relies
heavily on CMOs to manufacture its
products and has been alarmed at
the failings identified by regulators. It
has noted that the increasingly global
nature of manufacturing comes with
new risks. Representatives of the
industry are eager to improve the
current situation, particularly since any
manufacturing violations, even minor,
can disrupt the supply of medicines.
EFPIA, which represents
the European pharmaceutical
industry, has produced a set of
recommendations for enhanced
GMP and good distribution practices
(GDP) inspection efficiency (18). While
wholeheartedly backing regulatory
inspections to ensure patient safety,
it has expressed concerns at the
way in which the current inspection
system is set up. In particular, EFPIA
believes that international regulatory
cooperation is suboptimal and there
is frequent duplication of inspection
oversight at manufacturing sites. This
problem leads to a misallocation of
resources and often means that high-
risk areas of the supply chain may
escape detection.
EFPIA has noted that a number
of regulatory agencies have
started to conduct international
inspections of manufacturing sites,
but these inspections provide
limited additional value to those
already conducted by domestic
bodies. Furthermore, on occasions,
there have been inconsistent
or diverging interpretations of
regulations by different inspectors.
Occasionally, inspectors have asked
companies for requirements beyond
the formal written standards.
EFPIA believes that resource
management for inspections should
be optimized through avoiding
consecutive inspections at the same
manufacturing site and by using risk
principles for scheduling inspections
in areas where they may be
particularly important. Another issue
identified by EFPIA was the demand
by many regulatory agencies for
documentation to be supplied before
the inspection. The administrative
burden of this requirement has been
increasing and yet companies are not
convinced that it has added any value
to identification of problems.
At present, drug development
is moving towards more complex
E X C E L L E N C E I N P H A R M A C E U T I C A L A N A L Y S I S
• Quality Control Testing
• Method Development & Validation
• Stability Storage & Testing
MHRA & FDA APPROVED
ISO17025 ACCREDITED
54-56 Waldegrave Road, Teddington, Middlesex TW11 8NY
Telephone: +44 (0) 20 8977 0750 Fax: +44 (0) 20 8943 2624 Email: [email protected] Website: www.butterworth-labs.co.uk
Pharmaceutical Technology Europe EuropEan outsourcing outlook 2015 s7
ES582641_PTESUPP0315_007.pgs 03.11.2015 01:40 ADV blackyellowmagentacyan
Outsourcing Market
biological products. The commercial
cost of manufacturing monoclonal
antibodies can amount to
approximately US$1000 per gram (19).
Pharmaceutical companies involved
in this field will, therefore, have to
carefully choose their manufacturers
because of the considerable
investment and effort made in
equipment, systems, and staff by
both parties (i.e., the CMO and its
client) to ensure high product quality
and consistency of biologics.
Given the heavy investment in
newer therapies, companies are
likely to be wary that inspections
could potentially interfere with the
manufacture of such high-value
products. Any disruption in the
manufacturing activities of these
products would not only be financially
damaging to the companies involved
but also detrimental to the patients.
While there are no GMP violations
reported in the EudraGMDP for
biologic manufacturing, a US incident
serves as an example of what can
happen. In April 2014, FDA issued
a warning letter to the Mexican
company Instituto Bioclon regarding
significant violations of GMP for the
manufacture of the biologic drug
product, Anascorp, which is the first
specific treatment for scorpion stings
(20, 21). The violations included a lack
of appropriate written procedures
designed to prevent microbiological
contamination of drug products (20,
21). Anascorp is licensed to Rare
Disease Therapeutics Inc. in the US,
but manufactured by Instituto Bioclon.
The drug’s high price of approximately
US$50,000 generated considerable
media publicity (22). The impact
of ongoing FDA action will be felt
financially by the companies involved.
In addition, patients who require the
treatment will be unhappy at the lack
of availability.
SummaryThe global CMO market is set to
grow, but the increasing reliance
on outsourcing for manufacturing
capabilities by pharmaceutical
companies has led to concerted
international regulatory efforts to
ensure manufacturer compliance
with standards. A number of these
inspections have led to necessary
action against substandard
manufacturing practices that
endanger patient safety. Although
the pharmaceutical industry
supports regulatory standards of
manufacturing, it would like to see
improvements made to the inspection
system. If inspections are carried
out in an uncoordinated manner by
different parties and according to
heterogeneous requirements, this
will undermine the effectiveness of
the system and may damage the trust
between regulators, industry, and
other stakeholders.
References1. A. Nagurney et al., “Pharmaceutical
Supply Chain Networks with
Outsourcing Under Price and Quality
Competition,” presentation at POMS
Annual Meeting (Denver, CO, May
2013).
2. A. Lowe et al., Contract Manufacturing
in Life Sciences: The Need for an
Integrated Approach, www.lode-
stonemc.com/files/pdf/WP_Contract_
Manufacturing_in_Life_Sciences.pdf,
accessed 27 Jan. 2015.
3. MHRA, good Manufacturing practice:
guidance and legislation, www.
mhra.gov.uk/Howweregulate/
Medicines/Inspectionandstandards/
GoodManufacturingPractice/
Guidanceandlegislation/index.htm,
accessed 27 Jan. 2015.
4. EMA, “Ranbaxy, Toansa assessment
concluded: no risk to public health,”
Press Release, 5 June 2014.
5. EudraGMDP, http://eudragmdp.ema.
europa.eu/inspections/displayHome.
do, accessed 27 Jan. 2015.
6. K. Hammeke, “Trends in outsourcing
solid dose manufacturing in 2014,”
http://lifescienceleadermag.epubxp.
com/i/267232/17, accessed 27 Jan. 2015.
7. PR Newswire, “Life Sciences BPO
Market is Expected to Reach USD 596.0
Billion Globally in 2019: Transparency
Market Research,” Press Release, 3
Feb. 2014.
8. J. Miller, “CMO Exits Reduce Pharma
Manufacturing Capacity,” www.pharm-
source.com/thinking/outsourcing-
outlook/, accessed 27 Jan. 2015.
9. FDA, “FDA prohibits Ranbaxy’s Toansa,
India facility from producing and dis-
tributing drugs for the U.S. market,”
Press Release, 23 Jan. 2014.
10. Reuters, “Europeans, US differ over
safety of Ranbaxy facility,” Press
Release, 5 June 2014.
11. Reuters, “Germany bars antibiotic drug
from Ranbaxy’s central India plant,”
Press Release, 3 Dec. 2014.
12. WsJ, “US, India Clash Over Generic
Drugs,” www.wsj.com/articles/SB1000
14240527023038745045793748419140
31168, accessed 27 Jan. 2015.
13. new York times, “Medicines Made in
India Set Off Safety Worries,” Press
Release, 14 Feb. 2014.
14. R. Bate et al., “Poor Quality Drugs
and Global Trade: A Pilot Study,”
NBER Working Paper No. 20469, Sept.
2014, www.nber.org/papers/w20469,
accessed 27 Jan. 2015.
15. Biospectrum, “India, China top 2013’s
GMP failures,” www.biospectrumasia.
com/biospectrum/news/206001/
india-china-2013-s-gmp-failures-ema,
accessed 27 Jan. 2015.
16. GMP News, “EU GMP Inspectors
find 26 GMP Deficiencies at
Chinese API Manufacturer Hebei
Dongfeng Pharmaceuticals,”
www.gmp-compliance.org/
enews_04530_EU-GMP-Inspectors-
find-26-GMP-Deficiencies-at-Chinese-
API-Manufacturer-Hebei-Dongfeng-
Pharmaceuticals.html, accessed 27
Jan. 2015.
17. GMP News, “EMA publishes several
GMP Non Compliance Report,” www.
gmp-compliance.org/enews_04638_
EMA-publishes-several-GMP-Non-
Compliance-Reports.html, accessed 27
Jan. 2015.
18. EFPIA, Enhanced good Manufacturing
and good Distribution practices
(gMp/gDp) inspection Efficiency,
www.efpia.eu/uploads/documents/
EFPIA_Enhanced%20Inspection%20
Practice%20-%20Final_v8a_19May2014.
pdf, accessed 27 Jan. 2015.
19. H. Levine, “Challenges in the cGMP
Manufacturing of hESCs: Lessons
Learned from Monoclonal Antibodies,”
presentation at ISCT 2011 Annual
Meeting (Rotterdam, The Netherlands,
May 2011).
20. FDA, “FDA Warning Letter: Instituto
Bioclon, S.A. FDA,” Press Release, 16
Apr. 2014.
21. FDA, “FDA approves the first specific
treatment for scorpion stings,” Press
Release 3 Aug. 2011.
22. Kaiser Health News, “Treating A
Scorpion Sting: $100 in Mexico or
$12,000 in US,” http://kaiserhealth-
news.org/news/treating-a-scorpion-
sting-100-in-mexico-or-12000-in-u-s/,
accessed 27 Jan. 2015. PTE
s8 Pharmaceutical Technology Europe EuropEan outsourcing outlook 2015 PharmTech.com
ES582638_PTESUPP0315_008.pgs 03.11.2015 01:40 ADV blackyellowmagentacyan
WHEN YOU NEED TO BE SURE
SGS LIFE SCIENCE SERVICES
THE LARGEST NETWORK OF CONTRACT ANALYTICAL LABS
WWW.SGS.COM/LIFESCIENCE
SGS Life Science Services is a leading contract service organization providing pharmaceutical development, biologics
characterization, biosafety testing, quality control product release, and utilities qualifcation, as well as Phase I-IV clinical
research services. Whether your organization is large and global or small and regional, rely on SGS as your partner for
outsourced testing.
Operating a harmonized network of 19 wholly-owned laboratories in 11 counties across Europe, North America, and Asia,
SGS offers lean quality standards, reliability and regulatory / technical expertise... all within close proximity to you.
CONTACT US:
Europe: +32 10 42 11 11
North America : +1-973-244-2435
Asia : +65 63790 111
SGS IS THE WORLD’S LEADING INSPECTION, VERIFICATION, TESTING AND CERTIFICATION COMPANY
© 2
015
SG
S S
ocié
té G
én
éra
le d
e S
urv
eill
an
ce
SA
– A
ll rig
hts
re
se
rve
d
ES582813_PTESUPP0315_009_FP.pgs 03.11.2015 18:01 ADV blackyellowmagentacyan
BioPlan Associates’ annual studies have shown that
biopharmaceutical outsourcing has been growing
steadily at 12–18%, along with the overall biopharma
industry over the past five years. But recently, their
clients are allocating a greater percentage of their
budgets for contracting out activities previously
considered core business. It’s not surprising then to see
that capacity expansions are being planned by various
contract manufacturing organizations (CMOs). Smaller
CMOs, such as Cytovance Biologics (1) and Rentschler
(2), for example, in 2014, announced investments in
capacity expansions. CMC Biologics (Copenhagen and
Bothell, WA) purchased substantial facility capacity in
Berkeley, CA to prepare for accelerating growth, while
Lonza is sharpening its focus on biotechnology (3) given
the upswing in the outsourcing market.
These trends are reflected in the data from
BioPlan’s 11th Annual Report and Survey of
Biopharmaceutical Manufacturing Capacity and
Production (4). Based on BioPlan’s estimates, CMOs’
mammalian cell culture capacity—measured by
installed bioreactor volume—grew from 474,000 L
in 2008 to 790,000 L in 2013. Estimated microbial
fermentation capacity (in terms of installed bioreactor
volume) grew more slowly during that period, but
nevertheless, increased from 354,000 L to 400,000 L.
These capacity expansions are in response to
a general trend toward greater outsourcing by
biopharmaceutical manufacturers. In the 2014 study,
50% of companies were outsourcing at least some
mammalian cell culture production, up from 43% in
2006, with 58% outsourcing at least some microbial
fermentation production, up from 42% in 2006.
Furthermore, just 3 in 10 respondents expected to keep
all of their mammalian cell culture (30%) and microbial
fermentation (31%) production in-house by 2019.
In keeping with future increases in outsourcing,
CMOs also reported planned capacity expansions.
Respondents estimated that their facilities would
increase total mammalian cell-culture production
capacity by 39% during the 2014–2019 period, with
overall microbial fermentation capacity also set for an
increase, though a more muted one (19%).
Interestingly, those projections were down from a
year earlier, when CMOs expected significantly larger
capacity expansions for mammalian cell culture and
microbial fermentation. One reason may be that
CMOs reported more idle capacity in 2014’s survey:
on average, they estimated operating at 58% of their
mammalian cell-culture production capacity and 54%
of microbial fermentation capacity.
Hiring talent is going to be a problemDespite operating at lower levels of total capacity in
2014 (of course, 100% capacity usage is neither ideal
nor likely attainable), CMOs continued to forecast
capacity expansions. Concerns about a future glut
of outsourcing capacity may not be warranted. And
even though some biomanufacturers themselves
are seeking to offer some of their excess in-house
capacity as contract manufacturers, this increased
supply does not seem to be affecting CMOs’
intentions to expand their own capacity. Rather, the
big emerging struggle among CMOs appears to be the
need to contend with staffing bottlenecks.
Capacity expansions will, of course, require staff
expansions, too—and skilled, experienced staff, at all
levels, are simply becoming increasingly hard to find.
That’s particularly the case for process development
staff, who are likely to be among the most in-demand
in years to come.
BioPlan’s 2014 study asked industry respondents
(both biotherapeutic developers and CMOs) in what
areas they will be hiring new biopharmaceutical
production during the next five years. While process
development and R&D emerged as big areas of growth
(21% share of new hires), the top segment was in
production operations, where 31% of the industry’s
new staff in biomanufacturing will be hired. This
demand for process development staff is going to
create challenges. Indeed, more than 4 in 10 (42.3%) of
respondents cited current difficulties hiring upstream
process development staff at their facilities, with
this topping the list of ‘most difficult’ positions to fill.
Downstream process development staff followed,
cited by 35.2% of respondents, with process engineers
(26.8%) also a challenging hire (see Figure 1).
Indeed, process development jobs (both upstream
and downstream) have been consistently cited
in the past five years as difficult positions to fill.
This generalized bottleneck in hiring may also
reflect the continuing adoption of new initiatives,
new technologies, and facility expansions that
require specialized staff, such as process analytical
technology (PAT) and quality by design (QbD).
Hiring bottlenecks creating industry capacity problemsThe inability to hire qualified staff is having a
significant impact on capacity usage (see Figure 2). In
fact, the industry considers it one of the factors most
likely to create capacity constraints in the future.
Some of the top factors cited by survey respondents
CMOs Plan for Capacity ExpansionsIs there enough talent to go around?
Eric Langer is president
of BioPlan Associates,
tel. +1.301.921.5979, elanger
@bioplanassociates.com.
s10 Pharmaceutical Technology Europe EuRoPEAn outSouRCing outlook 2015 PharmTech.com
ES582620_PTESUPP0315_010.pgs 03.11.2015 01:39 ADV blackyellowmagentacyan
Capacity ExpansionsA
ll fi
gu
res
are
co
urt
esy
of
the
au
tho
r.
as likely to create a capacity crunch
by 2019 included:
• Facility constraints (52%)
• Analytical testing and drug product
release (41%)
• Inability to hire new, experienced
technical and production staff
(33%)
• Inability to hire new, experienced
scientific staff (29%)
• Physical capacity of downstream
purification equipment (28%).
Essentially, hiring difficulties figure
to be as prominent a challenge (if not
greater) as the physical capacity of
downstream purification equipment,
which is often seen as a major culprit
when it comes to existing constraints.
Hiring is one of the few factors
measured that has steadily grown as
a concern over the past few years.
For example, the 33% of respondents
indicating potential future capacity
constraints owing to the inability to
hire technical and production staff
represents a large increase from
fewer than one-quarter (24%) feeling
that way in 2010. Additionally, the 29%
sharing that concern with regards to
scientific staff is almost double the
proportion of respondents (16%) who
felt that way in BioPlan’s 2008 study.
Clearly, this is a growing problem.
CMOs worried about hiringCMOs appear to be even more
concerned than biotherapeutic
developers about this trend in
hiring. When the respondents were
segmented into those two groups,
the inability to hire new, experienced
technical and production staff was the
second-most cited factor likely causing
future constraints for CMOs, by
43.8%. (The comparable figure among
biotherapeutic developers was 31.8%).
CMOs were also more likely to see
future capacity constraints arising from
the inability to hire new, experienced
scientific staff (37.5% vs. 27.3%), the
inability to retain experienced technical
and production staff (37.5% vs. 20%),
and the inability to retain experienced
scientific staff (25% vs. 20%).
ConclusionThe future looks bright for contract
manufacturing. Biopharmaceutical
manufacturers are outsourcing more
activities and expect to be doing so to
a greater degree in the medium-term.
Along with that, outsourcing budgets
have been on the rise in recent years,
rebounding from a recession-induced
contraction. Contract manufacturers
are working to meet that demand,
with industry players of different sizes
and in different geographies securing
investments and breaking ground
on new facility expansions. Still, it’s
important to note that there are
challenges ahead for CMOs besides
increased competition from market
entrants. Facility expansions will require
new specialized staff, and finding,
developing, and retaining the right
talent is a consistent pain point. It takes
time and significant company resources
to build up the required expertise, and
much of the hiring that currently takes
place (at least anecdotally) is the result
of poaching talent. For second-tier
CMOs looking to attract more business
and strategically partner with clients,
being able to boast top technical
expertise is a significant (and arguably
requisite) factor.
The importance of attracting that
talent is not going away—and should
only grow as CMOs raise their levels
of sophistication and lead the charge
in new technology adoption. It will be
interesting to see how they go about
attracting and retaining the necessary
talent to do so.
References
1. Cytovance Biologics, “Cytovance
Biologics Breaks Ground on GMP
Warehouse and Manufacturing
Operations Facility,” Press Release
(Oklahoma City, OK, 28 Jan. 2014).
2. Rentschler, “Rentschler Expands
Single-Use Manufacturing Capacities,”
Press Release (Laupheim, Germany, 6
June 2014).
3. C. Copley, “Lonza to focus on pharma
as benefits from outsourcing,” Reuters
(23 Jan. 2014).
4. BioPlan Associates, 11th Annual Report
and Survey of Biopharmaceutical
Manufacturing Capacity and Production
(Rockville, MD, April 2014). PTE
Process development staff, upstream
Process development staff, downstream
Process engineers
Downstream operations staff
Cell culture techniques
Technology transfer
Source: 11th Annual Report and Survey of Biopharmaceutical Manufacturing, April 2014,www.bioplanassociates.com/11th
42.3%
35.2%
26.8%
19.7%
19.7%
19.7%
Figure 1: Areas where hiring difficulties exist in biopharmaceutical operations.
Source: 11th Annual Report and Survey of Biopharmaceutical Manufacturing, April 2014,www.bioplanassociates.com/11th
Facility constraints
Inability to hire new, experiencedtechnical and production staff
Inability to hire new, experiencedscientifc staff
Physical capacity of downstreampurifcation equipment
Inability to retain experiencedscientifc staff
51.8%56.3%
31.8%43.8%
27.3%37.5%
27.3%
20.0%25.0%
Biomanufacturers
37.5%
CMOs
Figure 2: Selected factors creating future capacity constraints, biotherapeutic
developers vs. CMOs.
Pharmaceutical Technology Europe EuRoPEAn outSouRCing outlook 2015 s11
ES582632_PTESUPP0315_011.pgs 03.11.2015 01:40 ADV blackyellowmagentacyan
Sh
an
no
n S
ten
t/E
+/G
ett
y Im
ag
es
Outsourcing continues to be part of pharma’s business strategy.
To gain insights on current trends in outsourcing and the
implications for CMOs and CDMOs, pharmaceutical technology Europe
conducted a roundtable discussion with industry experts. Participants
included Elliott Berger, vice-president, Global Marketing and
Strategy, Catalent; Antonio Magnelli, senior vice-president, European
Commercial Operations, Patheon; Cynthia Wooge, Global Strategic
Marketing, SAFC; Frédéric Gaussens, vice-president, Global Strategy
and Business Development, SGS; and Peter Soelkner, managing
director of Vetter.
PTE: As we see more consolidation in the pharmaceutical
industry, what is the impact on contract manufacturing
and outsourcing trends? Are there any particular activities
that tend to be outsourced more than others?
Magnelli (Patheon): Every market always
moves naturally toward optimization, with the
aim of increasing competitiveness between
the main players. Every merger, consequently,
leads to natural consolidation of the business,
driven by supply-chain optimization. The CMO
market is following the same trend, moving more
toward consolidation, with the best performers
becoming full-service partners to the pharma industry, not serving
as only occasional suppliers. These partnerships not only focus on
the general capabilities of a CMO, but also on the possibility to offer
extended services to support clients from early stage to market.
Gaussens (SGS): The impact of consolidation in the pharma
industry can go both ways. For instance, on the one hand, you
could have a scenario where a larger pharmaceutical company
acquires another, and the result can be that work that was
previously outsourced is immediately internalized on the directive
of the acquiring company. Typically, this action can be justified by
the acquiring company initially needing to evaluate any particular
Moderated by
Adeline Siew, PhD,
editor of
pharmaceutical
technology Europe.
Moving with the Changing Tides of Outsourcing
capacities it may have as a result of
the consolidation. This being said,
we can point to examples where
a consolidation represented an
opportunity. In the second type of
scenario, there are instances where
SGS has been able to leverage
its existing relationship with the
acquiring company to gain immediate
credibility with the acquired company.
Over the past decade, there has
been an evolution in the kinds of
activities that are outsourced. In the
past, contract analytical outsourcing
typically consisted of more routine or
‘commodity’ kinds of services. Large
pharmaceutical companies were
reluctant to outsource high-value
services and projects that required
more method development. However,
what you find now is that more
companies are open to contracting
out high-value activities such as
cell-based assays, formulation, and
biologics characterization.
Soelkner
(Vetter):
As we have
seen with the
consolidation
in the
pharmaceutical
and biotech
industry, there has also been similar
activity in the service partner network
that supports this industry. Typically,
large pharmaceutical and biotech
companies prefer to have a small
number of carefully chosen long-term
strategic partners rather than a large
number of single contractors. This
approach helps reduce administrative
oversight, including handling and
managing efforts, while also helping
to negotiate price.
Outsourcing is often done when
either the drug or its corresponding
manufacturing process is highly
complex, or when in-house
production is not able to be
performed economically due to
the volume or special nature of the
drug. A further reason to outsource
manufacturing is the flexibility it
affords in being able to react quickly;
for example, having a partner to help
with fill and finish operations at times
of peak demand. Thus, the partners
are considered an extension of their
fill and finish network.
Industry experts share their perspectives on the evolving
outsourcing landscape and how current trends are shaping the
increasingly competitive contract manufacturing sector.
s12 Pharmaceutical Technology Europe EuropEan outsourcing outlook 2015 PharmTech.com
ES582627_PTESUPP0315_012.pgs 03.11.2015 01:40 ADV blackyellowmagentacyan
With the largest network of harmonized bio/pharmaceutical
GMP product testing labs worldwide, Eurofins BioPharma
Product Testing is everywhere you are.
While delivering a true local lab experience, our
international presence ensures personal quality service
backed by a unique global breadth of harmonized
capabilities to solve all your testing challenges.
For the most complete range of global testing services,
harmonized quality systems and LIMS, you’ll never
need to look further than your own backyard.
Chemistry/Biochemistry
Cell Banking Services
Facility & Process Validation
Method Development & Validation
Microbiology
Molecular & Cell Biology
Raw Materials Testing
Release Testing
Residuals & Impurities Testing
Stability Testing & Storage
Viral Clearance & Viral Safety
Professional Scientific StaffingSM
Services
Belgium
Denmark
France
Germany
Ireland
Italy
Spain
Sweden
U.S.
Facilities
www.eurofins.com/biopharma
BioPharma
Product Testing
Right In Your Backyard.
The Largest Global
Footprint of Harmonized
Testing Labs...
ES582806_PTESUPP0315_013_FP.pgs 03.11.2015 18:00 ADV blackyellowmagentacyan
Outsourcing Trends
Berger (Catalent): There has been
a shift that has seen the pharma
majors increasingly outsource to
a smaller number of suppliers that
possess a wide range of services,
technologies, and expertise.
These partnerships are starting
earlier in the drug development
process, sometimes in the late
discovery phase, because with more
challenging molecules, there is
increased need to help optimize the
API and formulations of new drugs,
encompass deeper engagement
including analytical and clinical
support, and last longer, through
late-stage clinical manufacturing,
scale up, and global commercial
manufacturing. Consolidation has also
resulted in increased interest from
Big Pharma in partnering on more
complex and specialized capabilities,
including drug development, instead
of just outsourcing space capacity.
Wooge (SAFC): A sizable increase
in outsourcing has been seen in
recent years, even among Big
Pharma. This trend is especially true
for APIs using specialized services
or technologies. An example in this
class are antibody drug conjugates
(ADCs), which require specialized
handling for highly active containment
and biologics processing, as well as
sophisticated analytical methodology
for their development and
manufacturing.
PTE: Outsourcing was
primarily driven by cost
reduction in the past, but
a lot has changed over the
years. What are the key drivers for
outsourcing today compared to the
past decade?
Wooge (SAFC):
The primary
drivers today
are quality and
speed to clinic for
new therapeutic
molecules. When
an innovator
company can partner with a CMO that
is highly experienced in the target
technology, efficiency in product
delivery can be gained along with
lower capital and resource usage
internally. In the case of ADC and
highly active compounds, specialized
handling and containment is required,
so these types of products are
outsourced to minimize capital outlay.
Berger (Catalent): Sponsors are
more focused on seeing solution
providers as long-term collaborators,
with whom they can have the
confidence and assurance of long-
term supplies where appropriate.
The complexity of products and
development projects is rapidly
increasing, and the industry is looking
for specialized expertise to help bring
these products to market rather than
cost-based outsourcing of routine
activities.
Large pharmaceutical companies
continue to focus on its core
capabilities in developing new
drugs and taking them to market,
and outsourcing enables them to
conserve capital and energy in this
space as opposed to driving lower
costs. In the current market, the
need to outsource to gain specialized
expertise and technology, supplied
reliably and at high quality, far
outweighs the cost factor.
Soelkner (Vetter): Today,
large pharmaceutical and biotech
companies tend to focus their efforts
on the late-stage development and
marketing activities for drugs in
special indications, such as cancer or
haemophilia drugs. They are primarily
concerned with their business
activities and will often cooperate
or merge with other companies
operating in the same area to bring
about synergies in these activities.
Because they focus on those
elements of the business, they often
outsource their fill and finish work to
specialty firms as much as possible.
In our discussions with larger
companies, it has been our
experience that price is not
necessarily the decisive factor in
choosing an outsource partner.
Rather, they are looking for a partner
that can support drug development
and manufacturing effectively and
efficiently.
Gaussens (SGS): In the past,
the relationship between the
pharmaceutical company and
the contract analytical service
provider was more transactional
and largely driven by cost. Today,
however, price alone is no longer
the main consideration. Drivers
now include strong project
management and more open, pro-
active communication. Additionally,
companies expect service providers
to have transparency with regards
to project issues that may arise, and
they expect to have a dialogue with
the service provider on resolution.
Successful service providers can then
set proper expectations with regards
to on-time delivery.
Magnelli (Patheon): Clients are
looking for a lean supply chain,
favouring service relationships
and partnerships over purely price
negotiations. The focus is now on
integrated support and partnerships
with shared mutual goals. Clients
share future pipeline opportunities,
allowing their CMO partner to grow
with them in a common direction.
Key drivers for success as a CMO
include the ability to foresee and
anticipate client needs as well as the
flexibility to adapt to expectations.
Every CMO has to evolve and create
an organization that is capable of
contributing to the client’s strategy,
not only guaranteeing them ‘units,’
but providing solutions that are
integrated and seamless.
PTE: As the outsourcing
landscape evolves,
how have clients’ priorities
and expectations changed?
Soelkner (Vetter): As outsourcing
projects to qualified specialists
continue to increase, so too does the
expectation for high-quality results.
Customers today expect state-of-
the-art equipment, laboratories,
and filling lines at their partners’
sites to enhance the quality of their
manufactured drug. They also expect
the highest possible flexibility in
equipment and processes. To meet
the specific needs of a product, the
service provider must be able to offer
both small- and large-scale filling
lines as well as stainless steel and
disposable equipment. The service
provider must also have the capability
to process various systems such as
bulk and presterilized glass, as well as
polymer drug-delivery systems.
Gaussens (SGS): Today, especially
with more biologics in development,
companies are looking for providers
s14 Pharmaceutical Technology Europe EuropEan outsourcing outlook 2015 PharmTech.com
ES582619_PTESUPP0315_014.pgs 03.11.2015 01:39 ADV blackyellowmagentacyan
Outsourcing Trends
that can serve as medium- to long-
term partners. The level of technical
competence is now more important,
as the types of services being
outsourced has changed. This being
said, companies typically engage the
service provider with an initial project
to demonstrate their capabilities.
Here is where project management
and an open dialogue are key in
dealing with issues and setting
client expectations. Because failures
at this stage can impact product
development, companies are more
demanding with their expectations.
Consequently, they are more apt to
abandon a service provider lacking
in competence, whether it be project
management or technology-related.
With stakes so high, companies are
not inclined to babysit a service
provide nor a project.
Magnelli (Patheon): In addition
to a lean supply chain and strategic
partnership, clients expect robust
quality and continuity. It is important
to meet increased customer demand
for integrated global solutions and
improved quality and regulatory
experiences, through building a
culture committed to reliability
and scientific excellence. On-time
delivery, simplicity, speed and quality,
are essential in demonstrating
commitment and success to a client.
Our clients seek CMOs with clear
investment strategies for future
growth that will deliver on the
promise of speed to market as well as
simplified and reliable supply chains.
Wooge (SAFC): Expectations
for outsourcing have changed from
CMOs being a low-cost provider of
large-volume APIs to that of a partner
providing a high-value, collaborative
service to expedite delivery of highly
complex new products into the clinic
and through commercialization.
There is an emphasis on technical
excellence and regulatory compliance
and knowledge, in which the CMO
can reliably provide both the product
and the necessary support for
regulatory filings.
Berger
(Catalent):
Long-term
relationships
with a smaller
number of
suppliers
require a
joint governance structure that
fosters deeper, multi-site global
relationship building. Better
communication is at the heart of a
successful long-term relationship,
and tools such as gate-review
techniques and transparent
balanced scorecards help toward
continuous improvement in
cooperation. These partnerships
also need quality agreements
that unite the two parties in a
single supply and quality chain.
Big Pharma increasingly expects
a high level of expertise, quality.
and innovation from the CDMOs
that they partner with, as their own
R&D and operational budgets are
focused on fewer priorities.
Materials Development • Testing • Assurance
SUPPORTING PHARMACEUTICAL
MANUFACTURERS
NEW
PHARM
ACEUTIC
AL
QUALIT
Y C
ONTRO
L TESTIN
G
LABO
RATO
RIE
S
www.lucideon.com/pte
Pharmaceutical Technology Europe EuropEan outsourcing outlook 2015 s15
ES582618_PTESUPP0315_015.pgs 03.11.2015 01:39 ADV blackyellowmagentacyan
Outsourcing Trends
PTE: How can CMOs and
CDMOs remain
competitive? And what are
the attributes of a
strategic partnership that benefits
both parties?
Berger (Catalent): CMOs and
CDMOs will need to continue to invest
in new, differentiating technologies
that Big Pharma does not possess
in-house. By collaborating early and
enabling pharmaceutical companies
to bring truly differentiated products
to market, both the payers and the
patients will ultimately benefit.
Additionally, suppliers will need
to provide customized solutions
to smaller innovators who are
increasingly pursuing more
molecules further into development
independently.
Maintaining investment in both
quality and reliability is paramount
to maintain exemplary regulatory
compliance. A key policy at Catalent,
for example, is to harmonize
and strengthen its global quality
management system and to go above
and beyond what is necessary by one
single regulatory body.
Wooge (SAFC): CMOs and
CDMOs will need to stay abreast
of the rapidly changing technical
landscape to ensure they can meet
the demands of novel products being
developed. In many cases, these
new therapeutics are complex and
require multiple components. Having
a strong supply-chain network or
strategic partnerships that enable
the end-to-end seamless delivery
of APIs and drug product will offer
a competitive advantage to allow
innovators to focus on product
development instead of logistics.
These strategic partnerships are
most valuable when the independent
companies work together as a single
entity with the client and share
similar cultures and harmonized
operational practices.
Magnelli (Patheon): CMO
and CDMOs must be efficient to
compete, but the best way to
remain competitive is to focus
on being a highly reliable partner
that provides excellent quality
and on-time delivery. Becoming
a preferred partner will, in any
case, be dependent on the ability
to create relationships aimed at
sharing company strategies. Client
pipelines are one of the main drivers
for a CMO/CDMO strategy because
they offer the possibility to preview
and foresee market needs. CMOs
must develop solutions that lead
to robust product formulations,
simplified supply chains, and take
customer needs from start to finish,
from API all the way to commercial
supply. Through these partnerships,
customers find cost-effective support
for the launch of new products,
reducing the cost and time needed to
get to market, which is a ‘win-win’ for
clients seeking fair pricing and CMOs
seeking profitability.
Soelkner (Vetter): A key success
factor for a CDMO to remain
competitive today is to focus on key
competencies. That means ‘more is
not always better.’ Rather, a contract
services company must decide which
attributes it wants to excel at and
how it wants to be perceived in the
market. For example, a CDMO might
offer a wide service portfolio, or offer
highly competitive prices. Or, it may
be perceived as one that focuses
on high quality, offering a great deal
of experience in handling complex
compounds and manufacturing
processes.
‘Win-win’ partnerships are born
when a solid working relationship
between both parties is established.
Of critical importance in the
creation of this partnership is the
understanding between both parties
of the strategy and the business
roadmap. To achieve this, good
communication among team
members and peers is necessary,
though not always easy to achieve.
Differences in corporate cultures
and business models as well as
varying levels of knowledge and
experience at all levels are just a
few of the issues that can make
communication among parties more
difficult.
Nonetheless, once a good level of
communication is reached, the basis
for both parties to benefit is created.
The sponsor company gets valuable
time and resources to concentrate
on its core competencies, and the
strategic partner is well aware of the
sponsor’s expectations.
PTE: Has the increasing
globalization of the
pharmaceutical industry
added new challenges to
outsourcing? How can these
challenges be addressed?
Gaussens (SGS):
There are plenty
of challenges in
outsourcing in
an increasingly
global pharma
industry. For
instance, the
trend over the past decades was
establishing operations in Asia. For
pharmaceutical companies, the
move made sense given the fast
growth in China and India, with the
promise of lower costs. The reality,
however, is that issues such as
regulation on the local level as well
as the expectation of equivalent
quality of service have proven to be
initial hurdles. Over the past decade,
there has been more focus on these
quality and regulatory issues given
the scrutiny of the US FDA. These
issues do not need to be dealt with
in more mature markets such as
North America or Europe.
Soelkner (Vetter): A major
factor affecting the outsourcing
business is indeed globalization.
Drugs continue to be sold on a
global scale, and therefore, any
company doing business globally
must provide solutions that
meet the different market needs
efficiently and reliably. Consider,
for example, the Asia Pacific
(APAC) region; approximately 10
years ago, the medicines produced
within this region were primarily
intended to be used only there.
Today, there is a growing increase
in activities that are designed to
enlarge the customer base for drugs
manufactured within APAC to be
distributed to countries outside of
APAC. We expect this activity to
increase in the future.
With this change in distribution
comes increased challenge for
pharmaceutical companies and their
contract manufacturers who now
face competition from outside the
region. Manufacturing companies
must adapt to differing criteria of
the recipient countries if they are
s16 Pharmaceutical Technology Europe EuropEan outsourcing outlook 2015 PharmTech.com
ES582622_PTESUPP0315_016.pgs 03.11.2015 01:39 ADV blackyellowmagentacyan
Outsourcing Trends
going to be successful. For example,
they have to make certain that
distinct quality requirements are
met for countries located inside, as
well as outside, the APAC region.
As they enter this market, contract
service providers will be faced with
these challenges and must react
accordingly.
Wooge (SAFC): Globalization
in the pharmaceutical industry
is a reality—and certainly offers
challenges, such as operating
in multiple time zones, different
cultures and languages, as well as
dealing with import/export issues
and transport. These challenges can
be overcome with strong project
management and standardized
processes to ensure all aspects
flow together. However, to be
efficient, clear and transparent
communication is a must to
understand and mitigate the risks at
each step, and proactively provide
solutions as a team.
Magnelli (Patheon): The CDMO
market is becoming increasingly
global and companies must be able
to operate in international markets.
Pharmaceutical companies are
looking for the ability to work with
more than one manufacturing site
in a CDMO’s network, maintaining
regulatory compliance and
capabilities for clients. Offering
strategic services on a global scale
not only allows CMOs to serve
local geographic markets, but also
serves clients seeking long-lasting
relationships into the future.
Berger (Catalent): We believe
that local market access as well as
access to local talent are key. Service
providers constantly have to adapt
to frequent regulatory changes
and be on top of proposed shifts in
legislations to be able to advise their
clients through the process.
PTE: In your opinion, what
is the future outlook of
outsourcing?
Gaussens (SGS): The
future of outsourcing looks quite
good. Specifically, the addressable
market (i.e., the portion of the R&D
market that can be outsourced
because there are certain activities
that can never be contracted out)
will be broader than previously.
According to a recent Frost and
Sullivan report, the penetration rate
of outsourced services is presently
between 25–30% of the addressable
market (1). Within the next decade, it
is conceivable that this number can
reach 40–50%.
Berger (Catalent): The rate of
outsourcing will only increase.
Customers’ demands are becoming
more diverse and specialized, and the
need for partnering and collaborative
innovation with experts in such
fields can only be matched through
outsourcing.
Partnering enables pharma
to focus on capabilities and
minimize investment in specialized
technologies and capacity while
getting better products to patients
faster. For smaller companies,
time is the pressure to allow for
a return on investment to be
made as soon as possible, and
they recognize they are unable to
be experts in every stage of the
development or even to manage
multiple suppliers well. Allied to
this, they need integrated expertise
in development, formulation,
technology, manufacturing, clinical,
and regulatory expertise for any
given dose form (e.g., extractables
and leachables testing in inhalation
products or intravenous bags) and
in given geographies (e.g., how
ANVISA audits compare to FDA
audits).
Magnelli (Patheon): The
near future will bring further
consolidation, and success will
depend on building a strong
global presence with end-to-end,
integrated offerings. Outsourcing,
specifically by small and mid-size
pharmaceutical companies, will
continue to increase. The decision
to outsource will be different
for big, medium, and small-sized
companies, depending on their core
strategies. Outsourcing isn’t done
just for financial reasons anymore.
Outsourcing allows customers to
find smart business solutions for
simplified and reliable supply chains.
This approach allows customers to
focus on market growth and new
product launches with strategic
partners.
Soelkner (Vetter): In the injectable
area where our company is operating,
we see that further growth is
forecast, with biologics being the
major reason behind it. This growth
represents significant opportunities
for companies operating in the
contract services sector that
support pharmaceutical and biotech
companies.
Also, the continuing erosion of
the blockbuster model combined
with the fact that many promising
new drugs come from small
biotech companies, means further
opportunity for CDMOs to help
guide these small companies and
provide support early in the drug-
development process. CDMOs
subsequently can also continue
their partnerships with large
pharmaceutical companies after an
out-licensing process is realized.
There are, however, challenges to
recognize, and a good deal of hard
work is required to overcome these
challenges. For example, there is an
ever-increasing regulatory oversight
of the contract services industry
that is necessary to enable the safe
manufacturing of drugs. This is a
factor that every company operating
in this sector must pay special
attention to if they want to succeed.
They must work hard in ensuring their
quality systems stay ahead of the
market.
Wooge (SAFC): The market for
outsourcing continues to look strong,
especially for complex technologies.
With the recent rise in quality
citations in API manufacturing sites,
especially in Asia, there will be an
even stronger emphasis on quality
and transparency in outsourced
programs. Organizations that have
earned excellent reputations as CMOs
will continue to be sought after as
valued partners.
Reference1. Frost & Sullivan, “Global
CRO Market Transformation,
Developments, Opportunities and
Future of CRO Market,” www.
reportlinker.com/p02672043/
Global-CRO-Market-Transformation-
Developments-Opportunities-and-
Future-of-CRO-Market.html, accessed
13 Feb. 2015. PTE
Pharmaceutical Technology Europe EuropEan outsourcing outlook 2015 s17
ES582625_PTESUPP0315_017.pgs 03.11.2015 01:39 ADV blackyellowmagentacyan
Ima
ge
is
co
urt
esy
of
Ke
mw
ell.
Successful technology transfers require well-
established scientific strategies combined with
human acumen. Applying scientific knowledge to
practical problems is at the core of technology
transfers.
There are many reasons why a pharmaceutical
company would require a technology transfer. Some
of the main reasons include the lack of capacity and
resources, the lack of regulatory approvals at current
site, the need to secure the supply-chain network and
register an alternate/back up site, and to reduce cost
of goods sold (COGS) due to pricing pressures.
There are many complexities involved in a
technology transfer. To facilitate a successful and
seamless technology transfer, one must evaluate
the risks associated with the transfer and create a
risk-mitigation plan before the technology-transfer
process commences. Planning should take into
account any gap analysis of the equipment (not
only in the manufacturing plant, but also in quality
control); any challenges with the API or other raw
materials in terms of storage, process, and physical
characteristics; and current manufacturing practice
at the donor site compared to the receiving site, to
name a few. Table I shows the types of technology
transfers and the activities involved.
The process. Ideally, the donor and receiving site
will have their own guidelines to define the steps
of the technology transfer process. Figure 1 shows
the typical steps of a technology transfer process at
Kemwell.
The team. Apart from having well-defined
procedures and well-documented processes in
place, it is important that the right team manages
the process because the most important aspect
of a technology transfer is the knowledge that is
being transmitted back and forth between the
donor and receiving sites. An efficient technology
transfer department bridges the gap between the
two sites and helps solve any challenges that may
arise. The team streamlines the processes and
relieves much of the transfer pressure by acting as
a common medium and integrating the information
across both sites. Kemwell’s technology transfer
team, for example, includes project managers,
technical team members who have a broad range
of technical expertise, as well as subject matter
experts (SME) as and when the need arises. SMEs
could be from production, quality assurance, quality
control, R&D, procurement, or business development
departments. During the project kick-off, it is
important for this team to draw up project timelines
and set internal targets and deadlines to expedite
the execution of activities.
A crucial success factor in transferring technology
is project management. The project manager for each
product transfer should ensure that there is never a
period where there is no communication between the
sites. If hitches in the system are identified, escalated,
and resolved at the correct time, the receiving site
will secure a more robust process. Figure 2 shows
a synergistic approach for a successful technology
A.G. Damodhar is
senior manager of technical
services at Kemwell,
34th KM, Tumkur Road,
Teppada Begur,
Bangalore, 562 123, India;
Tel: +91 80 3928 5450;
Email: damodhar.ag@
kemwellpharma.com.
Technology Transfer:A Practical Science
The author discusses the complexities of a technology
transfer and presents a risk-mitigation plan that
may be implemented to facilitate the process.
s18 Pharmaceutical Technology Europe EuropEan outsourcing outlook 2015 PharmTech.com
ES582635_PTESUPP0315_018.pgs 03.11.2015 01:40 ADV blackyellowmagentacyan
It takes a unique blend of expertise
to deliver the right results
From clinical development to commercial production
At Vetter, we look at your product from every angle. And help you
find answers that make a difference in efficiency, productivity, safety,
quality, and growth. From initial process design through high-speed
fill and finish, learn how a partnership with Vetter will keep your
product moving smoothly towards success.
■ More than 35 years of experience in aseptic filling
■ Expertise with many compound classes, including biologics
■ Highly trained experts in key technical areas
■ Integrated life cycle management
■ Innovative drug delivery options
■ State-of-the-art cGMP manufacturing
■ Excellent global regulatory support
Vetter
Development Service
Vetter
Commercial Manufacturing
Vetter
Packaging Solutions
For US inquiries, please contact [email protected] ■ For Asia Pacific inquiries, please contact infoAsiaPacific@ vetter-pharma.com ■
For EU and other international inquiries, please contact [email protected]
Answers that work
www.vetter-pharma.com
To learn more visit our website and subscribe to our quarterly newsletter.
ES582811_PTESUPP0315_019_FP.pgs 03.11.2015 18:01 ADV blackyellowmagentacyan
All
fig
ure
s a
re s
up
plie
d b
y th
e a
uth
or.
Technology Transfer
transfer and the four factors
involved—manpower, machine,
material, and method.
Possible challenges in technology
transfer across both sites include:
• Obtaining a manufacturing facility
that meets regulatory requirements
• Identifying a pure-play CMO (no
products of its own) to ensure IP
protection of dossier documents
• Change of raw material source
• Evaluating the staff and their
knowledge at the receiving site
• Transfer of old established
products, where limited dossier
information is available
• Change in overall processing
timelines if there is a change in
equipment
• Inadequate documents from donor
site
• Maintaining equivalent
environmental conditions at
both sites (e.g., environmental
conditions in Europe are extremely
different compared to India)
• Equipment challenges due to of
different operating principles (e.g.,
process change from tray dryer to
fluid bed processor)
• Technical competency to tweak
the process from robust validation
without altering the original dossier
• Communication gap due to
language barriers (e.g., if the
dossier compiled is in a foreign
language).
Case studies The following are some examples
of the challenges that Kemwell has
resolved when receiving a transfer
from various global sites.
Table I: Types of technology transfers.
Type of tech transfer Activities Goal
Tech transfer from R&D to
production pilot areas
Execution of submission batches.
Execution of pre-clinical or clinical
batches.
To produce successful clinical
batches and to replicate R&D
process at a commercial scale.
Tech transfer from pilot areas to
commercial area
Execution of engineering batches,
validation batches with intended or
commercial batch size.
Optimization and validation of
intended production-scale batch
size, followed by launch of the
product.
Tech transfer of commercialized
products from existing site to new
site
Execution of engineering batches,
validation batches with intended or
commercial sellable batch size.
To identify and add new alternate
manufacturing site for an approved
commercial product.
Intra-site tech transfer Execution of engineering batches
and validation batches with intended
commercial sellable batch size.
Addition of alternate area,
equipment, materials etc. in the
existing site.
Figure 1: Steps in a technology transfer process.
s20 Pharmaceutical Technology Europe EuropEan outsourcing outlook 2015 PharmTech.com
ES582623_PTESUPP0315_020.pgs 03.11.2015 01:39 ADV blackyellowmagentacyan
Technology Transfer
Implementing new processes.
The challenge was to change the
equipment operating principle for a
drying process (i.e., changing from
direct heating static solids bed to
fluid bed dryer because the former
process had long cycle times).
The first step was to establish the
drying process parameters such as
the inlet and outlet temperatures,
critical process parameters (CPP),
fluidization, and whether generation
of fine particles due to fluidization
would lead to compression issues.
This was followed by evaluating
the drug product feasibility for
the change through detailed risk-
assessment. Scale-up batches were
executed using quality-by-design
concepts to generate limits for
the identified CPPs, followed by
generation of stability data before the
execution of the validation batches.
The impact of change on product
critical quality attributes (CQA)
was also studied. The product was
successfully transferred to Kemwell’s
Bangalore site and approved by the
concerned regulatory authorities. The
change significantly improved the
overall efficiency and robustness of
the product.
Increased impurities during
transfer. An existing commercialized
product had increased impurities
in the commercial batches. Upon
in-depth investigation, it was found
that the root cause of the issue
was the preparation of the drug
solution. Kemwell developed an
in-house equipment to overcome the
issue. SMEs from all departments
contributed to resolve this issue,
demonstrating the crucial role played
by SMEs in a technology transfer
team. The new process was made
more robust without altering the
original dossier.
Change in API. A client used a
specific pulverized grade of an API
that was not available at Kemwell’s
manufacturing site in India. A
scale-up of the batch was proposed
to understand the impact of API
micronization on the dissolution
parameters of the drug product
based on the solubility of the API.
An un-micronized API was used for
the trial batch and all critical test
parameters (including dissolution) were
studied and found to have no impact
on the final product. The outcome
resulted in markedly increased cost
savings for the customer.
Product-related quality issue.
The commercial manufacturing of a
certain product had to be stopped
due to some quality-related issues,
in this case, because the product
did not display uniform drug
content. Because the product was
a lifesaving drug, the problem had
to be resolved on an urgent basis
to avoid stock-outs in the market
for the customer. Kemwell and its
customer identified a joint taskforce
team and created a timeline to solve
the issue. The process was closely
monitored by both organizations.
Effective and quick communication
formed the core of this operation.
The lifesaving product reached the
patients well before any chance of a
stock-out. This example shows that
timely communication and decision
making is important for uninterrupted
product supply to market.
Change in coating process. A
tablet that formerly used a sugar
coating (which is an old manual
process) needed an enteric coating.
Kemwell used an automated coating
machine for this product. A few trial
batches were produced to finalize
the coating process parameters.
The spraying system was reworked
without impacting the equipment
qualification status. Optimization
batches were followed by validation
batches, all of which were successful.
The product was successfully
commercialized and 50 commercial
batches have been produced for
distribution.
ConclusionContract manufacturing of
pharmaceutical products is
significantly increasing for companies
as they focus more of their efforts
on the discovery and marketing of
newer products. Pharmaceutical
companies are constantly looking for
the right strategic partner for product
commercialization. Understanding
the science behind a successful
technology transfer will help
differentiate a CMO. Manufacturing
contracts last for decades and
hence, human attributes such as
trust, compatibility, and common
shared goals between CMOs and
pharmaceutical companies form
the core of a successful working
relationship. PTE
Figure 2: A synergetic approach to the following 4M factors will help facilitate a successful technology transfer.
Pharmaceutical Technology Europe EuropEan outsourcing outlook 2015 s21
ES582646_PTESUPP0315_021.pgs 03.11.2015 01:40 ADV blackyellowmagentacyan
Ima
ge
is
co
urt
esy
of
Gri
fols
.
The correct choice of a contract development manufacturing
organization (CDMO) involves detailed analysis of the options
available. This type of analysis requires financial resources and time.
The first aspect to consider is the project you are going to outsource,
which determines the type of CDMO and whether to choose a
transactional, tactical, or strategic CDMO. So what´s the difference
between one and the other?
A transactional partner is an indirect partner. This type of
transaction-based relationship provides little loyalty between both
parties. As soon as the transaction is no longer attractive, the
contracting organization moves on to another supplier or vendor.
A tactical partner is one that has some common business interest,
but different expectations. This kind of relationship can evolve to a
more strategic alliance when mutual success and trust come into play.
A strategic partner is a long-term business relationship where
both parties expect to grow together with similar expectations
about products and markets. Both parties are involved in the global
management of the product lifecycle. Risks and milestones are shared
and business objectives must be aligned. A global, full-service CDMO
can identify potential opportunities lying in the sponsor products and
suggest some innovative solutions. A limited number of sponsor–
CDMO relationships, however, are able to progress to strong strategic
alliances.
What to look for in a strategic partner?There are some key points to consider in guaranteeing a successful
strategic partnership:
• In a strategic alliance, both partners should obtain greater benefits
than they would from working alone, because the objectives of both
parties are aligned. Sharing certain resources can result in saving
time and investments, especially for smaller companies that do
not have the capital to build new equipment or new manufacturing
lines.
• There is a balanced expectation from both sides; this case is
especially relevant when the sponsor and CDMO have different
sizes. A relationship between a small CDMO and a large
pharmaceutical company can be extremely successful if based on
mutual trust and common objectives.
Marga Viñes is
senior product manager,
Contract Manufacturing,
Grifols International S.A.,
Avinguda de la Generalitat,
152–158, Parque de
negocios Can Sant Joan,
08174 Sant Cugat del Vallès,
Barcelona, Spain,
tel: (34) 935710500,
• The amount of time invested
in finding the right partner can
be rather long and it comes
with experience. The process
involves an accurate evaluation,
understanding of the objectives,
aligning different cultures,
and performing audits, which
all involve time and consume
resources. For this reason, it is
crucial to define exactly the type
of relationship you are expecting
from your CDMO to minimize risks
and obtain maximum efficiency.
The best recommendation would
be to start with companies
you already know. While this
approach could save time, it is
also important to ensure that
the current partner can offer the
services you need for the new
project. For those without any
prior experience with a CDMO,
a short visit to the contract
manufacturer is mandatory.
Looking at the facilities and
equipment, as well as talking
to the people at the potential
CDMO, will give you an idea of
the CDMO’s capabilities. These
first impressions provide more
information than you can imagine.
Less tangible factors to consider in CDMO selectionDon’t think of your product as merely
an item; behind each product, there
is a patient, and it is important not to
forget this aspect.
Both the manufacturer and sponsor
are responsible for product quality,
from the early stages to the final step
of the process. The manufacturing
company, however, holds the ultimate
responsibility. A valuable attribute for
any CDMO is, therefore, its integrity.
Product quality is considered
the most crucial success factor
for pharmaceutical contract
manufacturing in injectable products,
and quality remains the greatest
challenge when the sponsor works
with a CDMO.
Alignment of top management
between sponsor and CDMO
is another factor to take into
consideration. Creating synergies
between both parties requires more
than an objective and a strategy.
It involves optimal coordination
Sterile Solutions: How to Choose the Right CDMO?How do you know if you have chosen the right CDMO?
Do you just wait to have the answer when your product is out on the market?
s22 Pharmaceutical Technology Europe EuropEan outsourcing outlook 2015 PharmTech.com
ES582624_PTESUPP0315_022.pgs 03.11.2015 01:39 ADV blackyellowmagentacyan
Sterile Solutions
between teams and a global
framework to provide the best
solution for needs and process
requirements.
The responsiveness of the CDMO
should also be taken into account.
Throughout the project, the sponsor
and the CDMO will deal with
unexpected events that can disrupt
the schedule of the project. During
the development phase and earliest
stages particularly, the chance of
problems arising is greater. Therefore,
a fast and effective decision-making
process is an important asset to keep
the project moving. As a sponsor,
you are contracting a service but
you should let your CDMO suggest
improvements related with the
process, methods, and product.
Another factor to consider is the
CDMO´s attitude when faced with a
risk. Does the CDMO adopt a positive
attitude? Or does the CDMO refuse
to assume any risks due to a lack
of knowledge? Take time to answer
these questions in depth because
it will help to determine if this
company is the right CDMO for your
project.
Many reports show communication
as the top challenge of the sponsor-
contract service, especially if both
partners have different cultures.
Communication must be team-based
with individuals that are capable of
building winning relationships based
on honesty. Good communication
can help a project to move along
quickly, but poor communication can
lead to delaying the launch and even
affect the availability of the product
on the market. Both parties must
share all the information because
a lack of transparency will hinder
the progress of the project. Sharing,
even if it means sharing mistakes,
can streamline the next steps. For a
CDMO, It is acceptable if a project is
not awarded to your facility due to
technical reasons; however, don’t let
poor communication be the reason
for losing a project.
Four attributes to consider when choosing a CDMO—tenacity, credibility, flexibility, and simplicityTenacity. Be open to new challenges
even if it means making some
mistakes; this attitude will convert
the CDMO company into a more
competitive organization.
Credibility. While it is often easy to
talk about how well a CDMO works,
it is much better to show the results.
The best promotional campaign for
a CDMO is not an advertisement; the
best campaign is what customers tell
you.
Flexibility. The CDMO should be
flexible enough to adapt to sponsor
requirements but maintain its own
identity without losing the values of
the company.
Simplicity. A project can have
different approaches and points of
view but the main goal is always the
same (i.e., to try and make the job
as simple as possible and to be fully
committed).
Complexity of sterile manufacturing and outsourcing trendsInjectable dose formulations have
experienced strong growth despite
the dominance of solid-dose
formulations. The current trend is
to work with CDMOs that offer full
service capabilities from formulation
to commercial production. This trend
is expected to continue in the next
few years, driven by the following key
factors and requirements:
• Highly sterile and aseptic
manufacturing conditions. Access
to technology and equipment
requires high levels of investment.
• Parenteral manufacturing requires
a high level of automation to
minimize human interaction
with the product and avoid
contamination risks, as well as to
detect the presence of particles
using automatic controlling
processes.
• Skilled and experienced personnel
• Pharma and biotech companies
are switching to prefilled syringes
for existing and new products,
and also to ready-to-use (RTU)
containers to minimize potential
risks of contamination, which
is a result of less manipulation.
The RTU formulas are a top
market trend in the lifecycle
management to add value to a
product that has been on the
market for a long time.
The emerging markets are more
favourable to outsourcing solid
dosage forms than injectable
products that involve a more
challenging formulation, a complex
manufacturing process, and high
quality assurance requirements.
Lifecycle management for injectable productsA viable product lifecycle
management strategy is a key
tool that can help injectable drug
companies stay competitive in the
marketplace. One of the current
trends in the injectable field is to
move from a vial (concentrated) to
a pre-mixed solution (ready-to-use
formula). The advantages of a pre-
mixed solution compared to a vial
include:
• Less manipulation of the
container, which consequently
minimizes contamination and
medical errors
• Increased patient safety as a result
of minimizing the risk of receiving
an incorrect dose
• More safety for physicians because
the use of needles for preparation
is avoided and there is less contact
with cytotoxic drugs.
Reformulations are also used to
improve efficacy or for reducing the
frequency of injection. The CDMO’s
experience and knowledge are key
factors to take into consideration
when selecting the manufacturer for
such a project.
The approach is to select a
CDMO that can offer development
and manufacturing from vial
containers to premixed solution.
This approach allows the sponsor to
establish a long-term relationship
with the CDMO and work together
as strategic partners, taking into
consideration the requirements for
manufacturing capacity, regulatory
issues, potential investments, and
launch schedules. Working with
the same CDMO means saving
time and money and being able to
rely on someone you trust. Given
that the pharmaceutical contract
manufacturing market is expected to
grow, choosing the right CDMO can
determine the future success of your
company. PTE
Pharmaceutical Technology Europe EuropEan outsourcing outlook 2015 s23
ES582643_PTESUPP0315_023.pgs 03.11.2015 01:40 ADV blackyellowmagenta
Guide to Conventional and Biotech Pharmaceutical Outsourcing Services
AbbVie1401 Sheridan Rd
North Chicago, IL 60064 USA
Tel: 847-938-8524
Email: [email protected]
Website: www.abbviecontractmfg.com
Business Unit Head: Keith Kentala, VP Ops Comms
Sales Contact: Michelle Calhoun
Year Founded: 2013
Number of Employees: 501+See our ad on page 5
CONTRACT SUITE OFFERINGS
Analytical services: Chemistry & stability.
API and intermediates (cGMP, small molecule)
manufacturing capabilities: High-potency or
high-containment manufacturing.
Biomanufacturing: Cell culture; Prokaryotic
fermentation; Vaccines.
Commercial manufacturing: Active
Pharmaceutical Ingredients (API) and advanced
intermediates manufacturing (cGMP, small
molecule); Active Pharmaceutical Ingredients
(API) manufacturing - (cGMP, large molecules/
biologics); Ingredient processing (milling, coating,
etc.); Injectables manufacturing; Semi-solids &
liquids manufacturing; Solid dose manufacturing;
Specialty dosage forms.
Consulting services: Project & sourcing
management services.
Development & Phase I/II Clinical Trial
Materials (CTM): Active Pharmaceutical
Ingredients (API) - large molecule/biologics; Active
Pharmaceutical Ingredients (API) - small molecule;
Injectable products development; Solid dose,
semi-solids & liquids development.
Packaging & logistics: Clinical labels; Clinical
packaging & distribution; Commercial packaging.
Aenova GroupBerger Strasse 8-10
Starnberg, 82319 Germany
Tel: +49-8151-9987-0
Email: [email protected]
Website: www.aenova-group.com
Sales Contact: [email protected]
Year Founded: 2008
Number of Employees: 501+
Annual Revenues: €500 million+
CONTRACT SUITE OFFERINGS
Analytical services: Chemistry & stability.
Commercial manufacturing: Injectables
manufacturing; Semi-solids & liquids manufacturing;
Solid dose manufacturing; Specialty dosage forms.
Consulting services: Regulatory, validation, IT,
and QA/QC services.
Development & Phase I/II Clinical Trial
Materials (CTM): Injectable products development;
Solid dose, semi-solids & liquids development.
Packaging & logistics: Clinical packaging &
distribution; Commercial packaging.
Almac Group LtdAlmac House, 20 Seagoe Industrial Estate
Craigavon, Armagh BT63 5QD United Kingdom
Tel: +44-2838-332200
Fax: +44-2838-332299
Email: [email protected]
Website: www.almacgroup.com
Business Unit Heads:
Professor Paul Harkin, MD Almac Diagnostics
Dr. Stephen Barr, MD Almac Sciences
Dr. Robert Dunlop, MD Almac Clinical Services
Jim Murphy, MD Almac Clinical Technologies
Graeme McBurney, MD Almac Pharma Services
Sales Contact: [email protected]
Year Founded: 1968
Number of Employees: 501+
Annual Revenues: €500 million+
CONTRACT SUITE OFFERINGS
Analytical services: Bioanalytical testing;
Chemistry & stability; Particle characterization;
Product characterization.
API and intermediates (cGMP, small molecule)
manufacturing capabilities: Amino acids and
analogs; Asymmetric synthesis or chiral chemistry;
Biocatalytsis; Chemocatalysis; High-potency or
high-containment manufacturing.
Commercial manufacturing: Active Pharmaceutical
Ingredients (API) and advanced intermediates
manufacturing (cGMP, small molecule); Active
Pharmaceutical Ingredients (API) manufacturing -
(cGMP, large molecules/biologics); Ingredient processing
(milling, coating, etc.); Solid dose manufacturing.
Development & Phase I/II Clinical Trial
Materials (CTM): Active Pharmaceutical
Ingredients (API) - small molecule; Solid dose,
semi-solids & liquids development.
Packaging & logistics: Clinical labels; Clinical
packaging & distribution; Commercial packaging.
Baxter BioPharma SolutionsOne Baxter Pkwy
Deerfeld, IL 60015 USA
Email: [email protected]
Website: www.baxterbiopharmasolutions.com
Business Unit Head: Nelson Patterson,
VP Sls Mktg
Year Founded: 1931
Number of Employees: 501+
Annual Revenues: €500 million+
CONTRACT SUITE OFFERINGS
Analytical services: Bioanalytical testing;
Chemistry & stability; Microbiology; Particle
characterization; Product characterization.
API and intermediates (cGMP, small molecule)
manufacturing capabilities: Amino acids
and analogs; High-potency or high-containment
manufacturing.
Biomanufacturing: Vaccines.
Commercial manufacturing: Active Pharmaceutical
Ingredients (API) and advanced intermediates
manufacturing (cGMP, small molecule); Active
Pharmaceutical Ingredients (API) manufacturing
- (cGMP, large molecules/biologics); Injectables
manufacturing; Semi-solids & liquids manufacturing.
s24 Pharmaceutical Technology Europe EUROPEAN OUTSOURCING OUTLOOK 2015 PharmTech.com
ES582858_PTESupp0315_024_CL.pgs 03.11.2015 19:11 ADV blackyellowmagentacyan
Consulting services: Project & sourcing
management services; Regulatory, validation, IT,
and QA/QC services.
Development & Phase I/II Clinical Trial
Materials (CTM): Injectable products
development; Semi-solids & liquids development.
Butterworth
Laboratories Ltd54-56 Waldegrave Rd
Teddington, Middlesex, TW11 8NY United Kingdom
Tel: +44 (0)20 8977-0750
Fax: +44 (0)20 8943-2624
Email: [email protected]
Website: www.butterworth-labs.co.uk
Business Unit Head: Doris Butterworth, Mng Dir
Sales Contact: Daniel Morland, Mktg and
Bus Dev Mgr
Year Founded: 1974
Number of Employees: 51-100
Annual Revenues: €0-10 millionSee our ad on page 7
CONTRACT SUITE OFFERINGS
Analytical services: Chemistry & stability.
Catalent Pharma Solutions14 Schoolhouse Rd
Somerset, NJ 08873 USA
Tel: 732-537-6200
Fax: 732-537-6480
Email: [email protected]
Website: www.catalent.com
Business Unit Head: John Chiminski
Sales Contact: Will Downie
Year Founded: 1997
Number of Employees: 501+
Annual Revenues: €500 million+See our ad on page 28
CONTRACT SUITE OFFERINGS
Analytical services: Bioanalytical testing;
Chemistry & stability; Microbiology; Particle
characterization; Product characterization.
Biomanufacturing: Cell culture.
Commercial manufacturing: Ingredient
processing (milling, coating, etc.); Injectables
manufacturing; Semi-solids & liquids
manufacturing; Solid dose manufacturing;
Specialty dosage forms.
Consulting services: Regulatory, validation, IT,
and QA/QC services.
Development & Phase I/II Clinical Trial
Materials (CTM): Injectable products
development; Other delivery forms (transdermal,
inhalable...); Solid dose, semi-solids & liquids
development.
Packaging & logistics: Clinical labels; Clinical
packaging & distribution; Commercial packaging.
Corden PharmaOtto-Hahn-Strasse
Plankstadt, 68723 Germany
Tel: +49-62-02-99-2299/800-868-8208
Fax: +49-62-02-99-2000
Email: [email protected]
Website: www.cordenpharma.com
Year Founded: 2006
Annual Revenues: $251 million+See our ad on page 27
CONTRACT SUITE OFFERINGS
Analytical services: Chemistry & stability.
API and intermediates (cGMP, small molecule)
manufacturing capabilities: Acetylenic
chemistry; Acylation; Asymmetric synthesis or chiral
chemistry; Carbohydrate chemistry; High-potency
or high-containment manufacturing.
Commercial manufacturing: Active
Pharmaceutical Ingredients (API) and advanced
intermediates manufacturing (cGMP, small
molecule); Ingredient processing (milling, coating,
etc.); Injectables manufacturing; Semi-solids &
liquids manufacturing; Solid dose manufacturing.
Development & Phase I/II Clinical Trial
Materials (CTM): Active Pharmaceutical
Ingredients (API) - small molecule; Injectable
products development; Solid dose, semi-solids &
liquids development.
Eurofns Lancaster
Laboratories2425 New Holland Pike
Lancaster, PA 17601 USA
Tel: 717-656-2300
Fax: 717-656-3772
Email: [email protected]
Website: www.eurofnslancasterlabs.com
Business Unit Head: Timothy Oostdyk
Sales Contact: Michael McDowell
Year Founded: 1961
Number of Employees: 501+
Annual Revenues: $101-250 millionSee our ad on page 13
CONTRACT SUITE OFFERINGS
Analytical services: Bioanalytical testing;
Chemistry & stability; Microbiology; Particle
characterization; Product characterization.
Grifols Intl, S.A.Parc Empresarial Can Sant Joan
Avinguda de la Generalitat, 152-158
Sant Cugat del Vallès, Barcelona 08174 Spain
Tel: +34-93-571-21-99
Fax: +34-93-571-0722
Email: [email protected]
Website: www.partnership.grifols.com
Business Unit Head: Marga Viñes, Sr. Product Mgr
Sales Contact: Marga Viñes
Year Founded: 1940
Number of Employees: 501+See our ad on page 2
CONTRACT SUITE OFFERINGS
Commercial manufacturing: Injectables
manufacturing.
Development & Phase I/II Clinical Trial
Materials (CTM): Injectable products
development.
Pharmaceutical Technology Europe EUROPEAN OUTSOURCING OUTLOOK 2015 s25
ES582859_PTESupp0315_025_CL.pgs 03.11.2015 19:10 ADV blackyellowmagentacyan
Guide to Conventional and Biotech Pharmaceutical Outsourcing Services
Hapa AGChriesbaumstrasse 4
Volketswil, 8604 Switzerland
Tel: +41-43-399-32-00
Fax: +41-43-399-32-01
Email: [email protected]
Website: www.hapa.ch
Business Unit Head: Beat Rupp, CEO
Sales Contact: Stephan Wengi
Year Founded: 1933
Number of Employees: 101-250
Annual Revenues: €50 -100 million
CONTRACT SUITE OFFERINGS
Packaging and Logistics: In-process printing
solutions for the packaging industry.
LucideonQueens Rd, Penkhull
Stoke-on-Trent, Stafordshire, ST4 7LQ United Kingdom
Tel: +44 (0)1782-764428
Fax: +44(0)1782-412331
Email: [email protected]
Website: www.lucideon.com
Business Unit Head: Parmjit Bilan,
Pharmaceutical Bus Dev Mgr
Sales Contact: Melissa O’Brien
Year Founded: 1952
Number of Employees: 101-250
Annual Revenues: €10-25 millionSee our ad on page 15
CONTRACT SUITE OFFERINGS
Analytical services: Bioanalytical testing;
Chemistry & stability; Microbiology.
Consulting services: Project & sourcing
management services; Regulatory, validation, IT,
and QA/QC services.
SGS Life Science Services1 Place des Alpes
Geneva, CH 1211 Switzerland
Tel: +41-22-739-95-48
Fax: +41-22-739-98-33
Email: [email protected]
Website: www.sgs.com/lifescience
Business Unit Head: Frederic Gaussens,
VP Bus Dev & Strategy
Sales Contact: Frederic Gaussens
Year Founded: 1971
Number of Employees: 501+
Annual Revenues: €100-250 millionSee our ad on page 9
CONTRACT SUITE OFFERINGS
Analytical services: Bioanalytical testing;
Chemistry & stability; Microbiology; Particle
characterization; Product characterization.
Consulting services: Regulatory, validation, IT,
and QA/QC services.
Vetter Pharma Intl GmbHEywiesenstrasse 5
Ravensburg, 88212 Germany
Tel: +49-751-3700-0
Fax: +49-751-3700-4000
Email: [email protected]
Website: www.vetter-pharma.com
Business Unit Head: Oskar Gold, VP Key Acct
Mgmt & Corp Mktg
Sales Contact: Oskar Gold
Year Founded: 1950
Number of Employees: 501+
Annual Revenues: €400 millionSee our ad on page 19
CONTRACT SUITE OFFERINGS
Analytical services: Bioanalytical testing;
Chemistry & stability; Microbiology; Particle
characterization; Product characterization.
Commercial manufacturing: Injectables
manufacturing.
Development & Phase I/II Clinical Trial
Materials (CTM): Injectable products
development.
Packaging & logistics: Commercial packaging.
Wickham Laboratories LtdHoeford Point, Barwell Lane
Gosport, Hampshire PO13 0AU United Kingdom
Tel: +44-0-132-922-5500
Fax: +44-0-132-922-6688
Email: [email protected]
Website: www.wickhamlabs.co.uk
Business Unit Head: Chris Bishop, Tech Dir
Sales Contact: Lynne Murdoch, Ops Mgr
Year Founded: 1962
Number of Employees: 51-100
CONTRACT SUITE OFFERINGS
Analytical services: Microbiology.
Consulting services: Regulatory, validation, IT,
and QA/QC services.
AD INDEX
COMPANY PAGE
ABBVIE 5
BUTTERWORTH LABORATORIES 7
CATALENT PHARMA SOLUTIONS 28
CORDEN PHARMA INTL GMBH 27
EUROFINS LANCASTER LABORATORIES 13
GRIFOLS INTERNATIONAL SA 2
LUCIDEON LTD 15
SGS LIFE SCIENCE SERVICES 9
VETTER PHARMA-FERTIGUNG GMBH 19
s26 Pharmaceutical Technology Europe EUROPEAN OUTSOURCING OUTLOOK 2015 PharmTech.com
ES582860_PTESupp0315_026_CL.pgs 03.11.2015 19:11 ADV blackyellowmagentacyan
ES582812_PTESUPP0315_CV3_FP.pgs 03.11.2015 18:00 ADV blackyellowmagentacyan
TECHNOLOGY SELECTION & APPLICATION FORMULATION & ANALYTICAL SERVICES CLINICAL & COMMERCIAL SUPPLY TAILORED OR END-TO-END SOLUTIONS
Our 18 R&D teams in 10 countries are now
working on 500+ projects, applying multiple
proven and innovative drug delivery technologies
to help you deliver optimal release profi les,
enhanced bioavailability and better dose
forms—preferred by patients and payers.
best technologies. broadest expertise.faster development.
ʺ 2
015
Cata
len
t P
harm
a S
olu
tio
ns.
All r
igh
ts r
eserv
ed
. O
SD
rC i
s a
reg
iste
red
tra
dem
ark
of
San
wa K
ag
aku
Ken
kyu
sh
o C
o.
Catalent. More products. Better treatments. Reliably supplied.™
us + 1 888 SOLUTION eu 00800 8855 6178 catalent.com
new
Catalent Acquires Micron
Technologiesleader in particle
size engineering
Optimized particle distribution, shape and size, for enhanced bioavailability, stability and manufacturability. Proven particle size engineering technologies and integrated analytical services.
osdrc® optidose™ technology
rp scherer softgel technologies
zydis® fast-dissolve technologies
controlled release technologies
optimelt™ hme technology
micron particle size
engineering technologies
technology
spotlight
micron technologies
us + 1 888 SOLUTION (765 8846) eu 00800 8855 6178 catalent.com
ES582830_PTESUPP0315_CV4_FP.pgs 03.11.2015 18:05 ADV blackyellowmagentacyan