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1. Single Use &
Disposable Technology
in Biomanufacturing
Industry Overview
Pharma IQ
Sector Report & Resources
June 2011
In Association With
Disposable & Single Use Technology
Pharma IQ Sector Report & Resources 2011

2. Contents
3. Single Use Technologies Changing the
Biomanufacturing Landscape
5. In Demand: Prefilled Syringes
6. FDA publishes guidelines on H1N1 diagnostics tests
7. Creating new disposable solutions in Biomanufacturing
9. Economic Analysis of Single Use Tangential Flow
Filtration for Biopharmaceutical Applications (White Paper)
10. Additional Resources
11. Disposable Solution Online 2011
Authors: Andrea Charles | Tim Haidar | Helen Winsor | Richard DeSilva
Pharma IQ 2010 - 2011
Disposable & Single Use Technology
Pharma IQ Sector Report & Resources 2011

3. Pharma IQ Report
Single Use Technologies Changing the Biomanufacturing
Landscape by Eric Langer
During the past six years, single use systems and devices have emerged as a key change agent
in the biomanufacturing landscape. Acceptance in R&D and scale-up has been driven by their
effectiveness in reducing risks of contamination, faster changeovers, advantages over fixed
stainless steel systems in cleaning and validation, and significantly reduced time, and costs to
get a new facility up and running. Now, single use products have pushed beyond an early-stage
technology, and are poised to emerge into the much larger, GMP commercial-scale operations.
The emergence of single use devices onto the commercial stage is likely to create radical
changes in the biomanufacturing landscape. Key to this is first to resolve safety issues
associated with leachables and extractables. Comparability with existing processes (stainless
steel) will result in more rapid adoption rates.
The needs in single use technologies that will assure GMP operations—and biomanufacturers’
applications and integration of them--have driven end-users to demand vendors put R&D efforts
into these devices. In fact, according to BioPlan Associates, Inc.’s 2011 8th Annual Report and
Survey of Biopharmaceutical Manufacturing Capacity and Production[1], single use devices top
the list of key areas where biomanufacturers want to see product development.
Source: 8th Annual Report and Survey of Biopharmaceutical Manufacturing; Preliminary data,
pub April 2011; BioPlan Associates, Inc. http://www.bioplanassociates.com/
These responses for where new products are being demanded reflect both the growing
acceptance of disposable/single-use devices, and the growing need for better systems.
Nearly 39% of the industry wants vendor innovation in basic single-use devices, suggesting
significant opportunities for companies with inventive R&D initiatives and product development
capabilities.
Disposable & Single Use Technology
Pharma IQ Sector Report & Resources 2011

4. Pharma IQ Report
The need for more effective, standardised single use equipment is generally felt by both vendors
and end-users. Improvement is most strongly called for in "extractables and leachables” which
leads the list in “Reasons for Restricting Use of Single-Use Devices”, cited by 74% of 2011
respondents (up from 68% in 2010). These data suggest an opportunity for vendors with R&D
that delivers better materials. Both significant levels of innovation and incremental changes are
needed to spark improvements that facilitate use of single use devices. Survey respondents
indicated the following as specific areas in need of improvement:
• Simplifying change-over and cleaning operations
• Reducing overall capital investments
• Reducing risks of product cross-contamination
• Speeding up time to get facility up and running
• Improving campaign turnaround times
• Standardising devices to avoid costs of system modifications
• More ‘modular’ approaches
• Reducing space requirements
• Improving assurance of sterility
• Decreasing documentation requirements; simplify QA/QC
• Improving sterile-sampling
• Simplifying overall operations to reduce learning curve for new operators
• Improving control of bioreactors
• Reducing the need for operations staff
• Improving strength and reliability—to reduce bag breakage
Such solutions will require innovative leadership, process documentation, and training that
demonstrate how devices can be effectively integrated into operations. In fact, industry experts
believe process simplification will be the real driver for single use success. Single use vendors
are likely to see profitable opportunities when they go beyond the current new product strategy of
simply replacing stainless steel with plastics.
Hand-in-hand with innovation will be the need for standardisation of the currently-proliferated,
unique designs and devices. “While there is a huge amount of specific activity, we believe the
future of single-use technologies will include higher levels of integrity and quality, supply chain
security, faster delivery to customers and global material and specification standards for faster
implementation,” says Doug Neugold, CEO, ATMI.
To get to the next level of growth and efficiency will likely require a more ‘plug-and-play’ device
approach guiding product design and innovation. This kind of standardisation will also permit
greater efficiency and lower costs. Thus, to get beyond the current steady rate of adoption,
innovation may focus on making production easier for people with fewer skills, on a global
perspective.
[1] 8th Annual Report and Survey of Biopharmaceutical Manufacturing, Preliminary Data,
Publication Date April, 2011, BioPlan Associates, Inc. www.bioplanassociates.com
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Pharma IQ Sector Report & Resources 2011

5. Pharma IQ Report
In Demand: Prefilled Syringes
The prefilled syringes sector has witnessed healthy growth in recent years and demand is
expected to rise. This is due to the increased number of injectable biological drugs in the
pipeline and healthcare professionals and patients demanding safer more convenient
drugs, devices and delivery systems.
According to a recent iRAP report, PH-1 Nano-Enabled Packaging for the Pharmaceutical
Industry—A Global Technology, Industry and Market Analysis: “Global demand for
prefillable inhalers and prefilled syringes will generate the fastest growth opportunities
among all pharmaceutical packaging products, based on performance advantages in drug
delivery and the introduction of new bioengineered medicines.”
Advantages of prefilled syringes
A prefilled syringe is a single–dose packet of a parenteral drug attached to a needle by the
manufacturer, although traditionally used for vaccines and blood stimulants, they are now
used in a wide range of therapeutic areas. The main advantage when compared to single
glass vials is their ease of use. The user does not need to withdraw the required amount
of vial from a vial before using the syringe. By removing this step, prefilled syringes
provide a safer more convenient way for health professionals and patients to administer
injectable drugs. Prefilled syringes reduce human error and administer drugs with a higher
degree of accuracy because of this their popularity in the medical community continues to
rise.
It is not surprising that many pharmaceutical companies are adopting prefilled syringes as
their preferred way to deliver injectable drugs. In an article for OndrugDelivery entitled
Unilife – Developing Prefilled Products of Choice, Stephen Allen, Vice President of
Marketing and Communications at Unilife said: “More than 20 pharmaceutical
manufacturers are using prefilled syringes as a preferred delivery device for over 50
injectable drugs and vaccines that have a total combined annual sales of approximately
US$ 50 billion.”
Increased demand to throw away
Originally made of metal and glass, we are now seeing developments in disposable
prefilled syringes. In recent years, there has been a shift from glass to plastic syringes,
due to advances in materials construction and manufacturing processes.
Innovation in prefilled syringes and injection devices has also been spurred on by a
demand for disposable medical supplies on a global scale. Recent outbreaks of the H1N1
virus and a rise in nosocomial infections have pushed Infection prevention and vaccine
administration safety up the agenda. The Freedonia Group predicts in the Disposable
Medical Supplies report,thatUS demand for disposable medical supplies will increase 4.1
per cent annually to more than $79 billion in 2013.
Disposable & Single Use Technology
Pharma IQ Sector Report & Resources 2011

6. Pharma IQ Report
"Demand will also gain upward momentum as hospitals, outpatient facilities and other health
care establishments adopt stricter safeguards to meet infection prevention standards,” said the
report.
Injectable biotherapeutics on the rise- The prefilled syringes sector is also set to grow as the
use of biologics increases and the number of injectable biotherapeutics coming onto the market
is rising. The demand for prefilled syringes and other injection devices is high and many
contract manufacturers are taking advantage of this opportunity. Earlier this year AMRI acquired
Hyaluron for $27m (€22m) to enter the prefilled syringe contract manufacturer sector and
expand the customer base for its existing operations.
FDA publishes guidelines on H1N1 diagnostics tests
The U.S. Food and Drug Administration has released guidelines for manufacturers developing
diagnostic tests for the 2009 H1N1 influenza virus. The Secretary for the Department of Health
and Human Services declared a national public health emergency last April. Manufacturers are
now able to submit requests to the FDA for an emergency use authorization (EUA) for the test.
The guideline provides advice on exactly what information these requests should include.
During such a period of emergency, EUA provides the right for the FDA to sanction the use of
uncleared or unapproved medical supplies and the use of these materials, provided that specific
criteria has been met.
The FDA recognizes that manufacturers may not be able to produce full data of any clinical
validation normally related in premarket applications, but the new guideline offers suggestions
for fundamental facts, such as safety, effectiveness and careful interpretation of trial results.
A recent approval by the Administration to allow the expansion of a flu vaccine produced by
Australia’s CSL Ltd. to children over the age of 6 months, was achieved through an accelerated
approval regulation. Analysis was undertaken of the company’s seasonal antibody-inducing
vaccine in order to begin its distribution in the U.S. as a measure of protection from the life-
threatening disease.
The FDA also had to issue statements of assurance in the wake of doctors voicing concerns
over the limited trials of the vaccine. Commissioner Dr. Margaret Hamburg has expressed her
understanding of such anxiety, but confirmed safety has and continues to be closely monitored,
a stance so far reinforced by the lack of adverse effects found in clinical trials of 3600 patients.
Meanwhile, manufacturers are finding the need to push for more efficient processes in
developing vaccines for current and future pandemics. U.S. based Novavax, a company
developing a recombinant vaccine for H1N1, teamed with GE Healthcare to further the use of
disposable vaccine manufacturing systems based on GE's portfolio of single-use systems, and
more recently with Xcellerex, also known for its innovative disposable technology. The aim is to
avoid the extensive downtime accrued from the sterilization process required on older, stainless
steel biomanufacturing equipment, which in large-scale operations can struggle to meet the
need for rapid response.
Disposable & Single Use Technology
Pharma IQ Sector Report & Resources 2011

7. Pharma IQ Report
Creating new disposable solutions in Biomanufacturing
The cost-savings which disposable biomanufacturing systems can bring are well known, but the
problem for many organisations is how to take full advantage of these.
A key consideration for companies is how to generate savings in all areas of development and
manufacturing, as this can help to maximise both the efficiency and output of facilities.
One organisation which recognises the importance of this is ATMI, which recently announced it
has acquired the Belgian biotechnology firm Artelis SA, a specialist the field of highly-efficient
bioprocesses and technologies for cell culture research and manufacturing scale-up.
According to ATMI, the acquisition complements its work in ultra-pure single-use films,
bioreactors and mixing systems for characterising, developing, and manufacturing
biopharmaceuticals, as well as extends its global capabilities to a "broad range" of
biopharmaceutical process expertise.
In the last four years, the two firms have partnered to develop technologies that address the
rising demand for disposables in the life sciences research and manufacturing sector.
ATMI was an early investor in Artelis and this latest transaction has seen it acquire the remaining
equity position in the Brussels-based firm.
Doug Neugold, ATMI chief executive officer and president, said Artelis is an "innovator and
leader" in cell culture process optimisation for vaccine, veterinary and cell therapy applications.
He added: "This acquisition integrates those capabilities with ATMI's industry leading - and in
many instances enabling - single-use mixing and bioreactor technologies."
"Our combined capabilities make us an even stronger partner for our customers, as they look for
innovation to support their objectives of getting drugs to market more quickly and in the most
efficient way."
Jose Castillo, president of Artelis, said that the firm's customers will obtain the "immediate
benefit" of ATMI's global presence.
He pointed to ATMI's has state-of-the-art manufacturing operations in both Europe and North
America, which he claims is an "important consideration" for companies who rely on suppliers for
critical, single-use products.
In addition, ATMI also has project management, supply chain and quality assurance expertise, as
well as established distribution channels which are demanded by customers, the expert added.
As part of the transaction, the Artelis executive team have assumed new roles within ATMI
LifeSciences, while researchers and scientists working at Artelis will continue their cell culture
research and development as part of ATMI LifeSciences' R&D team.
Mario Philips, senior vice president and general manager of ATMI LifeSciences, said Artelis
represents a "compelling strategic" fit for the company and expands its commitment to the life
sciences market.
Disposable & Single Use Technology
Pharma IQ Sector Report & Resources 2011

8. Pharma IQ Report
While still at an early stage from a commercial ramp standpoint, the close collaboration with
customers and "world-class results" in cell line development and cell culture technology allow
them to provide the biopharmaceutical sector with comprehensive single-use solutions and
technical support, he noted.
Speaking to in-PharmaTechnologist shortly after the acquisition, he said the key motivation for
the acquisition was to "create more value for customers by going beyond the traditional value
proposition of disposables".
The need for a more flexible and reactive bioprocessing approach has been well publicised in
recent years, with the H1N1 outbreak and its industry response notable examples, but there are
some kinks in the chain that need to be addressed when it comes to issues such as the
validation and integration of single-use systems.
Mr Philips acknowledged that there is still work to do, but added that the company's aim is to
"bring high-purity and ultra-clean products to a level of breadth and depth not seen before in the
life sciences market".
He noted that both firms can help support the development of human and animal vaccines,
monoclonal antibodies and cell therapy applications.
Companies are finally beginning to recognise that money can be saved, yields increased and that
disposables are more environmentally sound, the expert argued.
"This shift in attitude is taking place as a result of the now proven benefits of single-use systems,
highlighting budding growth of this new disposable manufacturing industry," he concluded.
As these benefits become more well-known, the importance of devising a long-term, global
strategy to maximise the economy and flexibility of disposable biomanufacturing systems and
speed time to market will only continue to grow in the months ahead.
Disposable & Single Use Technology
Pharma IQ Sector Report & Resources 2011

9. White Paper
Economic Analysis of Single Use Tangential Flow Filtration
for Biopharmaceutical Applications
Tangential flow filtration (TFF) is a common processing step in concentration
and diafiltration (buffer exchange) operations in the downstream processing
of biopharmaceutical products.
Using a pre-sanitised, disposable TFF membrane makes it possible to
reduce the number of process steps and thus reduce labor by 50% or more
and reduce buffer and water usage by 75% or more.
In addition to the cost savings realised from the reduced labor and buffer
usage, single use TFF can increase productivity, by >45% in many cases.
This article outlines an economic model for comparing the costs of reusable
and single?use TFF in biopharmaceutical applications.
By Michael LaBreck, global product manager for TangenX technology, and
Mark Perreault, director of membrane application development for TangenX
technology, both at Novasep.
Download Here
Disposable & Single Use Technology
Pharma IQ Sector Report & Resources 2011

10. Additional Resources
INTERVIEW
Assessing the Impact of Single-Use Biomanufacturing Systems
With Dr. Kit Erlebach, Head of Technical Commercial Manufacturing at Avecia,
and Tony Hitchcock, Head of Process Science at Cobra Biomanufacturing
Whilst single-use systems have brought many advantages for bioprocessing, such
as accelerated downtime and reduced costs, there are still some challenges that
need to be addressed. Dr. Kit Erlebach, Head of Technical Commercial
Manufacturing at Avecia, and Tony Hitchcock, Head of Process Science at Cobra
Biomanufacturing, discuss new single-use technologies in the industry. They
examine the potential of these designs over the coming decade, assessing the
environmental impact, the ability to respond to emergency outbreaks, and the
means by which companies can introduce products into their existing facilities.
INTERVIEW
Transforming Biomanufacturing with Single-Use Systems
With Jerold Martin, Sr. V.P., Global Scientific Affairs, Biopharmaceuticals, Pall Life Sciences
In this interview Jerold Martin, Sr. V.P., Global Scientific Affairs,
Biopharmaceuticals, Pall Life Sciences and Chairman of the Board and
Technology Committee at the BPSA, speaks to Andrea Charles from Pharma IQ,
about future trends for Single-Use biomanufacturing and the advantages of
Single-Use systems for biomanufacturing. Martin also shares his
experiences regarding what factors to consider when implementing a Single-Use
technology and their environmental impact.
INTERVIEW
A Comparative Analysis of Single-Use Bioreactors – The Results
With Aurore Poles Lahille, New Technologies and Manufacturing Support at Merck Serono
Aurore Poles Lahille, Assistant Scientist and Specialist in New Technologies and
Manufacturing Support at Merck Serono Biodevelopment, joins Helen Winsor
from Pharma IQ, to discuss a comparative analysis of single use bioreactors and
understanding the most effective implementation. Poles begins with an overview
of the comparative study – the rationale, challenges and results, before talking
about the criteria used to assess whether the SUB is right for a particular system
and the best integration approaches.
Disposable & Single Use Technology
Pharma IQ Sector Report & Resources 2011

11. Devise a Long-Term, Global
Strategy to Maximise Economy
and Flexibility of Disposable
Biomanufacturing Systems and
Speed Time to Market
Glossary
Be part of the world's first online single use summit Event Highlights
Recent reports indicate that the market for disposables has been growing at 30% a year for the past few How it Works
years, which can be attributed to many things, primarily the huge cost-saving potential. Agenda
FAQ’s
With speed and flexibility also at the top of the priority list when it comes to biomanufacturing, it’s clear Check out the
why single use systems have seen such growth in recent years. However, streamlining your
Early Bird Sale!!
biomanufacturing facilities, managing suppliers and achieving operational excellence are all still areas
where much change and improvement is needed. Meet Your
Speakers
Do you have a strategic approach to implementing disposables or are you new to single use Pricing
systems? Register Today
Pharma IQ brings you an exciting industry first - Disposable Solutions for Biomanufacturing Online, which takes place
across September 2011. This is a truly global event, allowing us to bringing together the international biomanufacturing
and regulatory community in a dedicated forum to help you implement an effective single use systems strategy.
This interactive online event will bring together an international panel of thought leaders to discuss and debate the
opportunities and challenges that single use systems present for the biomanufacturing industry – all of this in a convenient
online format.
What Would you Ask the FDA? Here's your chance to hear directly from Ingrid Markovic, Expert review Scientist, CDER,
FDA and ask any burning questions! Ingrid is a resident expert on extractable and leachable studies and will be sharing her
knowledge on developing a risk based testing programme and the regulatory expectations are - get approval FIRST TIME!
This 100% online event begins September 6 and runs through to September 28, 2011.
In order to accommodate your schedule, we have spread this event over the course of a month so that you may attend at
your convenience. Simply log in to 2 sessions, twice a week. Presentations will also be available on-demand so if you miss
a session, you will always have an opportunity to catch up at a time that is convenient!
Be sure to secure your spot on the only single use system focused online summit
- Best practice guide to assessing the cost saving benefits of single use vs. fixed systems
Highlights
- A first hand overview on disposable systems regulatory requirements from FDA
- Establishing an effective supplier qualification process
- Successfully implementing the next steps to a global, industrial manufacturing scale using single use systems
- A compare and contrast study of different bioreactors from Merck Serono
- Applying QbD principles to disposable biomanufacturing
- Disposing of your disposables - efficient and sustainable waste management strategies
Disposable & Single Use Technology
Meet the Speakers
Pharma IQ Sector Report & Resources 2011