BIOLOGICSOVERVIEW BROCHURE
FLEXIBLE
BIOMANUFACTURING SOLUTIONS

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Jeff Hou, Ph.D.
Manager, Cell Culture Development,
Pharma Services
Princeton, NJ

LARGE MOLECULE DRUG
SUBSTANCE CAPABILITIESLet our biologics experts show you how tospeed development and unleash the potentialof your discovery.
Your molecule has the power to change lives and shape the future. Thermo Fisher Scientificis the company that offers you the flexibility and speed to help you get there ahead of schedule
while maintaining the highest quality. We bring deep scientific expertise to every challenge
and our proven track record of scaling up biologics helps ensure you gain cost and time savings
at every stage of the biologic development process.
Just as important, our people understand the long and complex journey ahead, and are ascommitted to your success as you are. We are driven by science and have the experience tosolve complex large molecule challenges.

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Discover flexible solutions
custom built on comprehensivecapabilities and experience.

UNLOCKING SUCCESS WITHOUTLOCKING YOU IN.
We pride ourselves on our ability to create flexible options forour clients. We understand the uncertainty associated withforecasting demand. We think strategically to offer biomanufacturing options that meet the unique needs of yourmolecule. We can work with your cell lines. Our contracts
are individualized to meet your requirements, we do not
require you to use proprietary technology, and we do not
charge royalties. Our strong reputation is built on successfullytransferring complex molecules.

QUICK TO CLINIC™ FOR BIOLOGICS DELIVERS
PHASE I CLINICAL TRIAL MATERIAL, FAST.
The pressure to file an IND makes accelerated Phase I
safety testing a priority. With the Quick to Clinic™ program,
Thermo Fisher Scientific can deliver your large molecule
drug substance for First-in-Human studies in as little as 12months. Now you can meet important milestones – such as
filing the IND – or secure additional funding with all theconfidence your project needs, and we can supply. Because
helping you reduce the time it takes to get your discovery tothe patients who need it matters, our Quick to Clinic™ forBiologics is made with speed and flexibility.

PROCESS DEVELOPMENT CAPABILITIES –FLEXIBILITY, QUALITY AND SERVICE.
We apply our deep process development skills to significantly
increase the batch yield and reduce processing time foryour molecule. Applying Design of Experiment (DoE) methodology to both Upstream and Downstream Processing, wedefine the CPPs and CQPs that enable robust processes,
maximize yields, and optimize throughput. For UpstreamProcessing, we utilize the Sartorius ambr ® 15 system platform
as well as 0.5 L, 1 L, and 10 L single-use bioreactors to define
optimal feed and processing conditions.

UPSTREAM PROCESSING CAPABILITIES.
With a fully integrated global network of cGMP facilities
across Europe, North America, and Australia, we are a leader
in manufacturing monoclonal antibodies and recombinant
proteins using single-use technologies. Our expertise spans
multiple commercial cell lines including CHO. And we specialize in fed-batch and perfusion cell culture processing.
Fed Batch Processing
Achieve stable reliable production at titers >5 g/L.

ANALYTICAL SERVICES THAT MEASURE
WHAT’S MOST IMPORTANT TO YOU.
Our analytical capabilities include rapid identification andcharacterization of your recombinant protein or antibody,development and implementation of cGMP methodologies
and data generation for regulatory submissions. Analyticalmethods are developed in process development by thesame teams that will use them in manufacturing to avoid
delays and errors created by handoffs. Our breadth of analytical services and capabilities include:
Analytical Methods and Method Validation

Perfusion Processing࡟࡟ Glycan profiling

Achieve high productivity and manufacture of unstableproteins.

࡟࡟ ELISA assays for product and impurity
assessments

Single-Use Technology࡟࡟ Gel and capillary based electrophoresis

Reduce technology transfer and scale-up risks andeliminate cross-contamination concerns. Multiple
single-use bioreactors: 250 L, 500 L, 1000 L, and 2000 L.

࡟࡟ Gel and capillary based isoelectric focusing࡟࡟ Residual DNA detection
࡟࡟ Cell-based bioassays

DOWNSTREAM PROCESSING CAPABILITIES.

࡟࡟ Immunologic and colorimetric assays

Thermo Fisher offers a range of purification processes thatensure your drug substance is of the highest quality andyield, including:࡟࡟ Mass spectrometry
࡟࡟ ICH stability testing࡟࡟ Depth filtration࡟࡟ Tangential and alternating tangential flow filtration
࡟࡟ UF / DF development

PROCESS VALIDATION – ENSURING RELIABILITYOF SUPPLY AND CONSISTENT QUALITY.
In late clinical phases, and as part of the establishment of
your commercial supply, Thermo Fisher provides a complete
validation package according to regulatory and cGMP
guidelines. BLA / PPQ-enabling process characterization andvalidation activities include:࡟࡟ Chromatography development
࡟࡟ Nanofiltration and virus inactivation
࡟࡟ Viral clearance studies࡟࡟ Final product formulation

࡟࡟ Validation of analytical methods

࡟࡟ Robustness studies

࡟࡟ ICH stability studies࡟࡟ Container shipment studies࡟࡟ CMC documentation in CTD format

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PERSONAL ATTENTION TO THE DETAILSAt Thermo Fisher Scientific, you’ll be assigned a project
manager who will serve as your main point of contact, as well
as a cross-functional team dedicated to designing a processthat meets the needs of your discovery and your business.
We also understand the unique role of consultants and offer
custom, flexible solutions aligned to your clients’ needs.

TECH TRANSFER FOR A STRATEGICAND FINANCIAL ADVANTAGE.
Technology transfers, either for a scale-up or a move to anotherfacility, are part of the normal course of business. Even when
the transfer is urgent, our team has a proven track record ofquick, effective executions to get your project back on track
and preserve product supply. In all cases, we are driven by
your deadlines, flexible in our approach and determined to
get it Right-The-First-Time, every time.

Flexible, end-to-end solutions
for development andcommercial production.
Work with one partner for both drug substance and drug
product manufacturing at the development and commercialscale. Our knowledge of formulation development and bioprocessing ensures that your molecule is “formulation
ready” regardless of the stage you are at.

CUSTOMIZED BIOMANUFACTURING SOLUTIONS
We offer a range of versatile solutions to overcome capacityrestraints while meeting the highest quality and regulatory
standards.
Global Network
Manufacturing locations in US, EU and Australia. Take
advantage of simplified logistics and R&D tax advantages.

FROM TRADITIONAL CAPACITY TO CUSTOMIZABLE MANUFACTURING MODULES.

Dedicated Capacity

Fractional
Ownership

Allocate capacity foreach of your products Sharing a line or
and transfer capacity facility lowers costin and out of the line. while allowing you
to achieve flexibility
and scalability.

Flexible NetworkAccessCondominium
Capacity

Get anytime accessto a specific type ofcapacity within ourglobal network.

A fully customized
solution that includes
everything fromdesign services
to operationmanagement.

Enterprise
For clients who
own facilities, weoffer operational
improvements andrepurposing ofexisting equipment.

A SCIENCE-DRIVEN APPROACH TO REDUCINGRISK AND REALIZING THE REWARDS.
Offering a depth and breadth of innovative biologic capabilities from development to commercialization. Pioneering
new technologies to improve the manufacturing process.
Focusing precisely on every step, but never forgetting theend goal. Thinking strategically to offer flexible, fast, efficientapproaches to helping your discovery through the complex
journey to market.

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SOLUTIONS

These are the scientists, engineers and professionals ofThermo Fisher Scientific. Who apply a science-driven, riskbased approach to every step of the biologic development
and manufacturing process. Who draw on years of experience.
And who partner with you at the stage of development that’s
most advantageous for your business. Because they believe
this is the best way to make certain your discovery lives up
to its promise to the patients who need it most.

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+1 919 226 3200 • thermofisher.com/patheon • doingbusiness@patheon.com© 2018 Thermo Fisher Scientific Inc. All rights reserved.
Published 9/18 PATH0736