Thermo Scientific HyClone Cell Culture Media ... - Thermo Fisher

Thermo Scientific HyClone
Cell Culture Media Capabilities
Scalability • Performance • Quality

Partner of Choice
Cell culture media and process liquids
Thermo Scientific Cell Culture and BioProcessing products deliver proven solutions at every
scale. We help to optimize your process and secure your product by supplying integrated
solutions for the biopharmaceutical market. Thermo Scientific HyClone Media, Supplements
and Reagents comprise the most commonly used formulations in today’s market, as well
as state-of-the-art, complete serum-free (SF) and chemically-defined (CD) media capable
of supporting superior cell performance. Our media and supplements are available in both
liquid and powder form, and can be packaged in a variety of handling systems based upon
your facility requirements.
In addition to a broad portfolio of media, supplements and process liquids, we offer an
extensive customization program. Proprietary or unique formulations are designed, tested
and manufactured following cGMP guidelines and packaged in a delivery system that
meets your needs. With a wealth of experience behind every Thermo Scientific product, you
are assured that your bioproduction process will perform at its best.
Providing bioprocessing solutions that fit your needs
• Customer-specific media, buffers and supplements
• Leading edge SF, CD and Animal-Derived Component Free (ADCF) platform media
• Innovative process supplements
• Ready-to-use classical media formulations
• Customization and optimization services
• Rapid prototype and custom formulation delivery
• Purpose-designed media delivery systems
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Visit our web site at www.thermoscientific.com/cellculturemedia

Scalability
Continuity in biotherapeutic and vaccine production supply
Our manufacturing facilities are designed to meet stringent regulatory requirements while
serving the global bioproduction market. With facilities around the world, we are able
to provide the desired product in a manufacturing lot size suitable for your application.
Additionally, we ensure the technical transfer process between our R&D organization or
your custom specification is correctly translated into our manufacturing processes.
To mitigate cross-contamination risks associated with animal origin material, and to meet
industry demands, we’ve established segregated manufacturing facilities. Our liquid
media and buffer facility offers up to 10,000 L lot sizes using traditional stainless steel
tanks. In addition, we offer the latest in single-use mixing technology, incorporating ADCF
film as a contact surface to provide rapid production turnaround times in a completely
single-use environment.
For powdered media and reagents, we offer two facilities: a traditional ball milling facility
for all formulation types, and an ADCF dedicated pin milling facility. Our ADCF pin milling
facility offers the highest level of production controls and is capable of delivering lot sizes
in excess of 6,000 kg.
• High quality products that meet expectations and specifications
• A culture of continuous improvement, implementing Lean and 5S principles
• Range of manufacturing lot sizes delivering consistent product performance
• Global manufacturing and logistics facilities
Flexible packaging options for secure containment of critical solutions
Liquids can be packaged for convenience in standard PETE and PETG bottles ranging from
50 to 2000 mL volumes, and in Thermo Scientific HyClone BioProcess Container (BPC)
systems ranging in size from 500 mL to 1,000 L. Powder products can be packaged in
high-density polyethylene (HDPE) bottles and pails, or in the Thermo Scientific HyClone
Powdertainer, a unique flexible packaging system capable of delivering units up to 25 kg.
To order or request additional information, call 1.800.618.4197.
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Performance
Accelerating productivity enhancements through collaborative solutions
A key to improved performance in biopharmaceutical development and manufacturing is identifying the
optimal medium and feed scheme. We’ve set up processes that enable custom media, feed supplement
and buffer manufacturing to ensure the highest level of product performance and quality. Our unique
ability to combine media and process liquid manufacturing with custom handling systems offers you the
best delivery solution for your bioprocessing needs.
For superior performance of cell culture platforms we offer:
• Standard serum-free formulations
• Classical media formulations
• Unique cell line formulations
By combining our knowledge of cell culture requirements with state-of-the-art analytical and
development equipment, we have the ability to evaluate and meet the specific needs of customer
cell culture processes. Our optimization program has the ability to thoroughly evaluate the nutrient
demands of custom cell culture systems, potential key component toxicities, necessary process-specific
supplementation and many other critical cell culture aspects, ensuring that the medium selection process
is a success.
Optimized Rapid Response Production
Throughout the optimization program, recommended changes in medium composition are carefully
evaluated for manufacturing suitability. This assessment engages our Rapid Response Production
(RRP) facility, to ensure that the finished, optimized medium can be manufactured according to your
requirements. RRP is our manufacturing service designed for non-cGMP applications of client-specific
media, process liquids and reagents with short turnaround times—typically within 7 days.
Our customization services enable bioprocessing success. Key contributing factors for our clients include:
• Rapid prototyping of client-specific media and reagents for optimal process development
• Robust process to support optimization objectives and specific manufacturing requirements
• Innovative state-of-the-art analytical services
• Integration of single-use technologies with cell culture applications development
• Cell Boost process supplements for fed-batch applications
• Broad line of platform serum-free and chemically-defined media
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Cell Yield
MAb Yield (mg/L)
Thermo Scientific HyClone products include high
performing serum-free media and feed supplements
capable of providing optimal cell culture conditions
for platform cell lines such as CHO, HEK 293 and
NS0. These media have been developed through the
Metabolic Pathway Design approach to ensure that the
needs of key bioproduction cell lines are met to enable
the highest level of productivity.
Days
Production of CD46 antibody in PER.C6 cultured in CDM4PERMAb
(fed-batch culture employed on days 4, 6, and 8 using Cell Boost 5).
Quality
Committed to quality… every step of the way
Our rigorous quality management systems ensure we consistently meet internationally recognized
regulatory requirements while exceeding customer expectations throughout our collaborative
process. As a leading supplier of cell culture and bioprocessing products, we provide innovations
and advances in cell culture that continually expand our knowledge and expertise.
Quality systems and risk mitigation plans
• Ensure consistency through global manufacturing harmonization
• Assure product supply and quality
Improved performance through quality management
• Meeting and exceeding your documentation and regulatory requirements
• Animal-free manufacturing segregation available using disposable liquid
management systems
• Consistent procedures and raw materials ensure equivalence
• Single-use advantages alleviate regulatory concerns
Validated and documented process
Products manufactured following:
• Medical Device Current Good Manufacturing Practices (cGMP) 21 CFR 820
• ISO 13485 (2003)—Medical Devices
• ISO 9001:2008
To order or request additional information, call 1.800.618.4197. 5

Complementary Products
Single-Use Systems
With decades of experience in optimizing cell
culture performance Thermo Scientific Cell Culture
and BioProcessing experts understand your
bioproduction needs. Our combined capabilities
in single-use technologies and cell biology will
maximize your results.
BioProcess Container
Along with our high-quality cell culture products,
BPCs deliver results at every scale. BPCs are
single-use, gamma irradiated products specifically
designed to be the ideal environment for fluid
handling. Our core technologies and expertise
support consistent, high performance products
that only the world leader in serving science can
provide.
Powdertainer
Improve powder handling and minimize the risk
of cross contamination with these single-use
systems that include a port for secure connection
to a formulation vessel and a clamp to retain
powder prior to dispensing.
Single-Use Bioreactor (S.U.B.)
Intended as a retrofit product capable of
integrating with existing control systems, our
design combines well-characterized elements
used in stirred-tank stainless steel systems, with
components offering all the benefits of singleuse.
The S.U.B. has been performance tested in a
variety of cell culture applications demonstrating
equivalence to conventional bioreactors.
Complementary products are designed to readily
integrate into your bioproduction processes.
Customization options are available to provide
products specifically configured to meet additional
requirements. All products are designed to fully
integrate with process liquids, media and sera to
provide complete systems for your bioprocessing
applications. Visit us at
www.thermoscientific.com/hyclone
for more information on BPCs.
Single-Use Mixer (S.U.M.)
The S.U.M. delivers proven effective mixing
of a stirred-tank system while using entirely
disposable, single-use contact surfaces. With
this, the S.U.M. allows you to take advantage of a
reduced initial hardware investment, shorter lead
time, quicker turnaround, enhanced productivity,
minimal chance of cross-contamination and
operational flexibility.
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A History of Innovation
A History of Innovation
Our vision is to be the leading supplier of quality solutions for challenges faced in the
biopharmaceutical industry and cell culture-based research. Our commitment to provide
the most innovative tools to facilitate and advance research is the foundation for all
Thermo Scientific Cell Culture and BioProcessing products.
For more than 40 years, our product experts have remained dedicated to the advancement
of science through the support of cell culture in academic research and bioprocessing
environments.
As a global manufacturer of sera, liquid and powdered media, process liquids and
single-use handling systems that support research and the production of
biopharmaceuticals, Thermo Scientific HyClone products continue to meet the highest
quality standards in the industry.
To order or request additional information, call 1.800.618.4197. 7

Cell Culture and BioProcessing
In the Americas and Asia
925 West 1800 South
Logan, Utah 84321
Tel: +1 (435) 792-8000
Toll-Free: +1 (800) 618-4197
Fax: +1 (435) 792-8001
www.thermoscientific.com/hyclone
In Europe
Industriezone III, Industrielaan 27
9320 Erembodegem
Belgium
+32 53 85 71 80
+32 53 85 74 31 fax
www.thermo.com/perbio
©2010 Thermo Fisher Scientific Inc. All rights reserved. HyClone, BioProcess Container, BPC, Powdertainer, Rapid Response
Production, RRP and Cell Boost are trademarks of Thermo Fisher Scientific. PER.C6 is a registered trademark of Crucell NV
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