bioproduction Single use Cell culture Purification Analytics

Integrated solutions
to enable your process
A collection of innovative products
for improved productivity
Chosen partner of the top 50 biopharma
companies worldwide
Your success is our priority
Achieve your bioproduction goals with solutions
designed for you
The promise of personalized medicine and emerging biologic markets,
and the need for large-scale pharmaceutical production create demands
that can only be met by working with flexible, cost-effective solutions and
a partner who’s focused on your bottom line.

Thermo Fisher Scientific is that partner. To help you achieve your

productivity and innovation goals, we deliver a complete offering of
integrated solutions designed to meet your specific needs. No matter
where you are in the bioprocessing workflow, you’ll find the products,
services, and advanced technical expertise to help you succeed.

Thermo Scientific™ and ASI™ single-use technologies

The go-to choices for customizable and rugged single-use systems.

Thermo Scientific™ POROS™ and CaptureSelect™ purification

Leading the way with high-resolution, high-capacity and high-specific solutions
for purification.

Gibco™ cell culture

Innovative media, sera, reagents and services recognized worldwide for
offering superior quality and consistent results.

Applied Biosystems™ SEQ analytics

The standard for rapid molecular methods in pharmaceutical manufacturing.
 We’re with you every step
of the way
Find industry-leading solutions across the entire workflow

You don’t need to work with multiple vendors to get what you need. With
applications that span the drug development process — from drug discovery
through large-scale commercial production — we’ll be your single source for
a broad range of solutions.

Upstream

Cell line development Mixing, cell culture Harvest and

and media optimization and fermentation collection

QC and analytics

Mycoplasma detection MicroSEQ™ microbial identification

Cell culture media, feeds Harvest and

Freedom™ CHO and enhancers separation products
cell lines
Single-use fermentors,
bioreactors, mixers Storage and transport
Process development
services
BioProcess
Containers (BPCs) Acclimate freeze/thaw
containment system
Media optimization
Inflation and integrity
services
test system
Single-use
sampling system
Single-use
heat exchanger

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 Downstream

Purification Bulk storage and final fill

QC and analytics

Analytical columns Sample prep and automation

Storage and transport

POROS™ chromatography resins

Single-use fermentors,
bioreactors, mixers

CaptureSelect™ affinity ligands

and resins Single-use BPCs, manifolds
and containers

Transfer assemblies Single-use filling system

Acclimate freeze/thaw
containment system

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Thermo Scientific and ASI
single-use technologies
Revolutionize your biopharma manufacturing
Single-use technologies have made a substantial
impact on drug development capabilities.
Thermo Scientific single-use technologies enable
rapid changeover, improved efficiencies and
ease-of-use, making it possible to produce small
amounts of drug product suitable for preclinical
research and clinical research in smaller facilities.

Our comprehensive suite of single-use technologies

for up-stream and downstream bioprocessing
include bioreactors, fermentors, mixers, storage
and transportation systems, at-use integrity testing
technology, single-use heat exchangers and
much more.

For our single-use bioprocess containers (BPC), we

offer redundant manufacturing on two continents.
Through the combination of Thermo Scientific and
ASI films, we offer our clients the option of true dual
sourcing of different BPC films from a single supplier.

Choice and Flexibility

Many customers have specific needs and require
customized solutions tailored to their bioprocessing
needs. Whether you need a custom BPC, a complex
manifold or a simple transfer assembly comprised of
various pieces, we have validated a large number of
components to build the solution you need.

Did you know?

We manufacture more than 1 million BPC chambers
annually. These chambers have wide-ranging uses,
from storage and transport to the most sensitive cell
culture and bioprocessing applications.

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Success story: Build-out of a new, flexible
facility
Situation A customer was considering building a new
facility, but was struggling with high upfront
costs for stainless steel systems, long setup
times, high operating costs and an inflexible
facility structure.

Solution To meet their needs, we collaborated with

engineering firms to implement single-use
technologies, including single-use mixers
and 50–2,000L single-use bioreactor trains.

Results • 40% reduction ( from $75M to $45M) in facility

and capital investment.

• 34% smaller facility footprint, resulting in lower

energy costs and less water usage.

• Simplified personnel and material flow.

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Thermo Scientific POROS and
CaptureSelect purification
Add process flexibility while maintaining quality and efficiency
Increased titers and product demand have caused
substantial bottlenecks in downstream processing for
antibodies as well as recombinant proteins and other
biomolecules. Our high-capacity and high-yield
POROS Chromatography Resins and CaptureSelect
Affinity products are specifically designed to address
these challenges.
High-resolution, high-capacity chromatography
resins for bioseparation
Produced in a state-of-the-art manufacturing facility,
POROS Chromatography Resins lead in downstream
monoclonal antibody (MAb) and recombinant protein
(rProtein) chromatography, where capacity, resolution
and yield are critical. And they are designed to deliver
superior performance compared to conventional soft
gel resins. That’s why they’ve been rapidly adopted in
more than 150 new processes since 2010.
POROS products and services:
• Bulk resins for high-performance and • POROS CaptureSelect HPLC columns
high-throughput large process-scale bioseparations.
• Analytical columns for analytical and lab-scale
preparative applications, in 10- and 20-micron
particle size.
• Services available for worldwide technical support.
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High-quality, cost- and time-saving custom
affinity purification solutions
CaptureSelect Affinity products are created
specifically for the purification and analytics of
biopharmaceuticals using proprietary technology
based on Camelid-derived single domain antibody
fragments. We offer a complete collection of affinity
products for the manufacturing of antibodies and
antibody fragments, recombinant proteins, biosimilars,
gene therapy vectors and vaccines. CaptureSelect
affinity ligands are manufactured in a completely
animal-origin free production process.
CaptureSelect products and services:
• CaptureSelect process chromatography
resins for process-scale purification.
• CaptureSelect lab-scale purification products
for discovery, preclinical and QC applications.
for small-scale purification and analysis.
• Custom services for the development
of product-specific affinity ligands and
chromatography resins.
Success story: An optimized approach for AEX
polish chromatography to drive productivity
Situation A customer wanted to increase the productivity
of their anion exchange (AEX) flow through a step
that used a soft gel resin, which required large
column volumes and long cycle times due to
relatively low linear velocities (~100 cm/hr).
Success story: Enabling manufacturing of
Gene Therapy vectors
Situation • No platform for purification of Adeno-Associated
Virus (AAV) – a commonly used gene
therapy vector
• Old, labor intensive process was not scalable

Solution Following an evaluation of Thermo Scientific™ hampering commercial development of

POROS™ HQ resin as a more efficient alternative,
we proposed an optimized AEX format with faster
Solution
flow rates and shorter bed heights. We also
provided extensive technical support for process
optimization, column packing and column lifetime.
Results • Increased flow rate from 4 min residence time
to 0.7 min, allowing for a 10x reduction in cycle
Results
time and a much smaller column.
• Increased protein load by 2.5x while maintaining
needed yield, robust viral clearance and
product quality.
• Optimized process efficiencies and
cost-savings.
AAV-based gene therapy
• Custom Ligand Development program focusing
on purification of a variety of AAV vectors
• Process conditions needed to maintain
infectivity
• Novel AAV affinity resin increased purity and
yield, decreased the number of process steps
and overall process time and reduced COGs
• Used in clinical and commercial production
processes (a gene therapy product approved
in Europe)
• Novel developments ongoing to develop
affinity resins for other serotypes (e.g. AAV8)

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Gibco cell culture
Maximize productivity by leveraging 50 years of
knowledge and experience
Gibco cell culture represents over 50 years of
Advanced Granulation Technology (AGT)
applying deep scientific expertise to redefine
upstream possibilities. To help you drive productivity, Granulated cell culture media is an easy-to-use,
we offer a full array of innovative performance granular form of dry media produced by applying
solutions and knowledge-based services including: fluid bed granulation technology to cell culture nutrient
media manufacturing. Our proprietary process allows
• Cell line development – from fast and flexible production of complete formulations of a variety of
serum-free, protein-free and chemically defined media
Gibco™ Freedom™ CHO cell line development kits
in a dry format.
to cell line services.

• Media, feeds, and supplements: Gibco Media Express Custom Media

– Protein expression – variety of basal media,
Take advantage of Gibco product quality with fast and
super-concentrated supplements and additives. reliable custom service. Gibco™ Media Express™
– Bioprocessing liquids – buffers, water for Custom Media combines Gibco quality with quick
turnaround and smooth transition for cGMP scale-up.
injection (WFI) to support upstream and
Whether you’re working with your own formulation, a
downstream processing. public domain or a Gibco proprietary formulation, we’ll
work to deliver your media when you need it.
– Viral vaccine expression – support major
vaccine cell lines with a broad selection of
scalable serum-free, animal origin–free formulations.
“More innovative format
• BSE-negligible origins of fetal bovine sera
(FBS) and other animal sera. options than any other
• Gibco BioProduction Services:
– Quality custom media development and optimization.
cell culture suppliers.”
– Spent media analysis, stability studies and assay
development of scalable serum-free, animal
origin–free formulations.

Most of the media and feeds are customizable

and available in various formats: Gibco™ Advanced
Granulated Technology™ (AGT™), dry powder media,
liquid and concentrate.

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Success story: Optimizing media format for
cost savings and risk reduction
Situation A large biotech company’s new drug
formulation required four separate dry media
components in their process.
• Each component requires a separate
raw material release test.

• Multiple components require

additional storage for containers.

• Formulation errors due to multiple

components can be costly.

Solution Proposed format upgrade from dry powder

media (DPM) to Advanced Granulation
Technology (AGT). We combined the four DPM
components into one AGT-powdered medium
for their commercial process.

Results • Reduction in on-site container inventory

for storage and staff handling (one AGT
component vs. four DPM).

• Reduction in the total number of required

raw material release tests.

• Formulation and mixing efficiencies

due to single-component media and
fast rehydration.

• Reduction in potential formulation errors (both

on working floor and in QC).

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Applied Biosystems
SEQ analytics
Enabling product quality and safety with rapid molecular
methods for pharmaceutical manufacturing
When sensitivity, accuracy and time-to-results Biologics impurity analysis:
are critical, SEQ analytics offer right-the-first-time • Mycoplasma detection.
reliability based on proven DNA sequencing and
• Host cell residual DNA quantitation.
qPCR technology. SEQ solutions detect viral and
microbial contaminants, quantitate process- and • Protein quantitation.
cell-based impurities, and identify bacterial and fungal
• Automated sample preparation.
species, with results typically in less than five hours.
• Real-time PCR instrument.
• Real-time qPCR detection software.
“Used in 23 of • Implementation and training services.
the top 25 pharma
companies, with many Microbiological contaminant analysis:
• Microbial identification of bacteria and fungi
multisite adoptions.”* • Automated sample preparation.
• Thermal cycler.
• Genetic analyzer.
• Analysis software.
• Validation services: IQ/OQ.
• Implementation and training services.

*Based on a list of Top 50 companies from PharmExec 50, Pharmaceutical Executive Magazine, 2014.

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Success story: Reducing mycoplasma testing
from 28 days to less than 1 day
Situation Mycoplasma detection is difficult, sometimes
impossible, when using traditional microbiological
techniques. The current Mycoplasma test is a
28-day culture test. It’s slow and labor intensive.
Solution Working together with the customer, we replaced
the traditional 28-day lot release test with our
rapid qPCR-based MycoSEQ test.
Results • Rapid, sensitive qPCR Mycoplasma detection
in less than 1 day.
• High specificity to detect more than
90 species.
• Accepted by the FDA and EMA as an
alternative for the 28-day test for Mycoplasma
detection.
Success story: Implementation of ResDNASEQ
kits to drive process characterization
efficiency
Situation Customer wanted to bring residual host cell
DNA testing in-house due to high cost per
sample and slow time-to-results at a contract
testing lab. However, the customer lacked
the specialized technical capability internally
to develop and qualify a method to quantitate
residual host cell DNA.
Solution Meetings were held with the customer to
introduce Applied Biosystems™ ResDNASEQ™
kits, answer technical questions and outline the
path to implementation. A pharma analytics
field application scientist performed an on-
site demonstration, highlighting the ease of
use and high sensitivity of the assay with the
customer samples. Based on the successful
demonstration, the customer purchased a
qPCR system, kits and training.
Results Customer was able to implement the system
and initiate testing in less than a month,
cutting 10–14 months off a typical method
development timeline. The cost per valid result
was reduced from over $1,400 per sample to
less than $200. Lower cost, higher throughput,
rapid time-to-results and high sensitivity enabled
the customer to validate robust DNA clearance
in their purification process.
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bioproduction

Get what you need, when

you need it
Our global manufacturing facilities are equipped
to deliver confidence
High-quality products to meet your Grand Island, NY
high standards • Cell culture media, regents.
• Sera.
• ISO 13485.
Quality is our top priority, from product • FDA registered.
design to supplier management. All of our
state-of-the-art, ISO-certified facilities meet
rigorous quality standards.

Dependable supply delivery to help meet

your production demands
Logan, UT
We go to great lengths to ensure you have the • BioProcess Containers.
products you need. Some of our key initiatives • Single-use technologies.
include: • Class 10,000/ISO 7
clean room.

• Manufacturing redundancy for key cell culture

and single-use products.

• Rigorous protocols for effective prevention

and recovery from operational disruption.
Matamoros, Mexico
• BioProcess Containers.
• Customer-specific inventory production and • ISO 13485.
future demand planning. • FDA registered.

Millersburg, PA
• BioProcess Containers.
• Single-use technologies.
• ISO 13485.
• FDA registered.
Bedford, MA
• Chromatography resins
• ISO 13485

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 Single use Cell culture Purification Analytics

Cramlington, UK
• BioProcess Containers.
• Class 10,000/ISO 7
clean room.

Paisley, Scotland
• Cell culture media, reagents.
• ISO 13485.
• FDA Registered.

Warrington, UK
• Analytics kits.

Naarden, The Netherlands Auckland and Christchurch, New

• Affinity ligands. Zealand; Newcastle, Australia
• ISO 9001 certified. • Sera.
• Protein products.
• FDA registered.

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Exceptional technical
service and support
Advance confidently with a support team
that’s ready and able to help
Your work is important. And we’re here to give you what you need to make it easier,
faster and more efficient every day. Whether you need assistance with protocols,
product transitions or technical consultation, our team of experienced professionals
is ready to help you any time, anywhere. Together we can advance bioproduction
to help make the world better, safer and healthier for everyone.
Contact your sales representative or email bp@thermofisher.com to learn
more about how we can partner for your success.

Find out more at thermofisher.com/bioproduction

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