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New Bioprocess Solutions From Molecule to Market Overcome Your Cell Culture, Purification, and Process Analytics Bottlenecks

Overcome Your Cell Culture, Purification, and Process ... · • Mammalian cell culture manufacturers are required to test for potential mycoplasma contamination; the current mycoplasma

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Page 1: Overcome Your Cell Culture, Purification, and Process ... · • Mammalian cell culture manufacturers are required to test for potential mycoplasma contamination; the current mycoplasma

New Bioprocess Solutions From Molecule to Market Overcome Your Cell Culture, Purification, and Process Analytics Bottlenecks

Page 2: Overcome Your Cell Culture, Purification, and Process ... · • Mammalian cell culture manufacturers are required to test for potential mycoplasma contamination; the current mycoplasma

Biologics manufacturing processes pose unique challenges.

From improving cell line titers, optimizing media formulations,

and scaling cell culture production to performing same-day critical

impurity analyses and reducing purification run times, we understand

the needs you face every day. The bioprocess manufacturing

solutions offered by Invitrogen and Applied Biosystems are driven by

one single goal—to move you more quickly from molecule to market.

Page 3: Overcome Your Cell Culture, Purification, and Process ... · • Mammalian cell culture manufacturers are required to test for potential mycoplasma contamination; the current mycoplasma

Powerful Upstream, Downstream, and Process Analytics Combinations

Bioreactors HarvestMedia

ColumnChromatography

Bulk DrugSubstance

Harvest/Cell

Removal

FinishedBatch ofActive

Substance

Mycoplasma Detection Residual DNA Quantitation Bacterial and Fungal Identification

SEQ Identification and Detection Systems

VirusClearance

Concentration

Cell Culture Purification Formulation

TransfectionCloneSelection

Expression VectorDevelopment

Cell Banks

Cell Line Development

PD-Direct® Services

GIBCO® Cell Culture Media POROS® Chromatography Solutions From Molecule to Market

Page 4: Overcome Your Cell Culture, Purification, and Process ... · • Mammalian cell culture manufacturers are required to test for potential mycoplasma contamination; the current mycoplasma

Powerful Upstream, Downstream, and Process Analytics Combinations

Page 5: Overcome Your Cell Culture, Purification, and Process ... · • Mammalian cell culture manufacturers are required to test for potential mycoplasma contamination; the current mycoplasma

A complete solution for stable cell line development

Page 6: Overcome Your Cell Culture, Purification, and Process ... · • Mammalian cell culture manufacturers are required to test for potential mycoplasma contamination; the current mycoplasma

OptiCHO™ Protein Express Kit

WHAT IS IT? • Complete set of products and serum-free workflow protocols to go from DNA to a stable protein-expressing CHO cell line

WHY IS IT IMPORTANT? • Save up to 6 months with optimized system and cGMP-documented DG44 parental cell line

• Reduced licensing burden compared to alternatives, no royalties

Contact your Invitrogen Sales Representative

www.invitrogen.com/opticho

Page 7: Overcome Your Cell Culture, Purification, and Process ... · • Mammalian cell culture manufacturers are required to test for potential mycoplasma contamination; the current mycoplasma

Add water.Reduce steps.Boost productivity.

Page 8: Overcome Your Cell Culture, Purification, and Process ... · • Mammalian cell culture manufacturers are required to test for potential mycoplasma contamination; the current mycoplasma

GIBCO® Cell Culture Custom Media and AGT™ Media

WHAT IS IT? • We can produce custom media in liquid batches from 10 L to 10,000 L, dry powder media (DPM) batches

from 1 kg to 8,000 kg, and proprietary Advanced Granulation Technology™ (AGT™) batches from 50 kg to 6,000 kg

WHY IS IT IMPORTANT? • Dual redundant manufacturing sites and robust supply chain strategy help customers

reduce risk as they scale up

• Customers who use AGT™ format love the convenience of a complete product

when compared to dry powder media (DPM)

Contact your Invitrogen Sales Representative

www.invitrogen.com/custommedia

Page 9: Overcome Your Cell Culture, Purification, and Process ... · • Mammalian cell culture manufacturers are required to test for potential mycoplasma contamination; the current mycoplasma

What happens when you pair the finest base medium with the perfect feed supplement?

Page 10: Overcome Your Cell Culture, Purification, and Process ... · • Mammalian cell culture manufacturers are required to test for potential mycoplasma contamination; the current mycoplasma

GIBCO® Catalog Media and Feeding Supplements

WHAT IS IT? • CD OptiCHO™ Medium and the CHO CD EfficientFeed™ Kit provide a base medium and feeding supplements that can

shorten the path to optimizing process development conditions at bench scale and assist with seamless scale-up

WHY IS IT IMPORTANT? • Chemically defined consistency without sacrificing performance

• 2- to 5-fold higher fed-batch productivity

Contact your Invitrogen Sales Representative

www.invitrogen.com/opticho

Page 11: Overcome Your Cell Culture, Purification, and Process ... · • Mammalian cell culture manufacturers are required to test for potential mycoplasma contamination; the current mycoplasma

Experience you trust—at high speed

Page 12: Overcome Your Cell Culture, Purification, and Process ... · • Mammalian cell culture manufacturers are required to test for potential mycoplasma contamination; the current mycoplasma

GIBCO® MediaExpress™ Custom Media

WHAT IS IT? • GIBCO® MediaExpress™ (GME) Custom Media offers GIBCO® quality custom media at high speed

• GME offers liquid batches from 1 L to 200 L, DPM batches from 1 kg to 5 kg, and AGT™ batches from 2 kg to 10 kg

WHY IS IT IMPORTANT? • Small volumes and quick turnaround give flexibility for process development customers to test multiple

formulations before scaling up to cGMP

• Fixed pricing offers ease in ordering

Contact your Invitrogen Sales Representative

www.invitrogen.com/mediaexpress

Page 13: Overcome Your Cell Culture, Purification, and Process ... · • Mammalian cell culture manufacturers are required to test for potential mycoplasma contamination; the current mycoplasma

less

More confidence and clarity for every phase of your drug development

Page 14: Overcome Your Cell Culture, Purification, and Process ... · • Mammalian cell culture manufacturers are required to test for potential mycoplasma contamination; the current mycoplasma

PD-Direct® Bioprocess Services

WHAT IS IT? • PD-Direct® Bioprocess Services offers outsourcing solutions for cell line development, cell culture media

optimization, and process optimization

WHY IS IT IMPORTANT? • The service offers customers the opportunity to access leading process development technologies

(i.e., SimCell™, ClonePix™, and Revolution® technologies) to improve process performance and accelerate time to market

• Customers receive expert technical consultation on process development problems, applications support

of Invitrogen products, and comprehensive service-based solutions

For more information, contact [email protected].

Page 15: Overcome Your Cell Culture, Purification, and Process ... · • Mammalian cell culture manufacturers are required to test for potential mycoplasma contamination; the current mycoplasma

Acholeplasma granularum • Acholeplasma laidlawii • Acholeplasma pleciae • Mycoplasma alkalescens • Mycop

Mycoplasma alvi • Mycoplasma arginini • Mycoplasma auris • Mycoplasma buccale • Mycoplasma californicum •

Mycoplasma canadense • Mycoplasma capricolum • Mycoplasma caviae • Mycoplasma collis • Mycoplasma fer-

mentans • Mycoplasma equirhinis • Mycoplasma fermentans • Mycoplasma gallicum • Mycoplasma gallisepticum •

Mycoplasma gateae • Mycoplasma genitalium • Mycoplasma gypis • Mycoplasma hominis • Mycoplasma

Mycoplasma hominis • Mycoplasma indiense • Mycoplasma lagogenitalium • Mycoplasma hyorhinis • Spiroplasm

Spiroplasma citri • Mycoplasma molare • Mycoplasma mycoides • Mycoplasma neurolyticum • Mycoplasma orale •

Mycoplasma pirum • Mycoplasma pneumoniae • Mycoplasma salivarium • Mycoplasma spumans • Mycoplasma pi-

rum • Acholeplasma granularum • Acholeplasma laidlawii • Acholeplasma pleciae • Mycoplasma alkalescens • Mycop

Mycoplasma alvi • Mycoplasma arginini • Mycoplasma auris • Mycoplasma buccale • Mycoplasma californicum •

Mycoplasma canadense • Mycoplasma capricolum • Mycoplasma caviae • Mycoplasma collis • Mycoplasma fer-

mentans • Mycoplasma equirhinis • Mycoplasma fermentans • Mycoplasma gallicum • Mycoplasma gallisepticum •

Mycoplasma gateae • Mycoplasma genitalium • Mycoplasma gypis • Mycoplasma hominis • Mycoplasma

Mycoplasma hominis • Mycoplasma indiense • Mycoplasma lagogenitalium • Mycoplasma hyorhinis • Spiroplasm

Spiroplasma citri • Mycoplasma molare • Mycoplasma mycoides • Mycoplasma neurolyticum • Mycoplasma orale •

Mycoplasma pirum • Mycoplasma pneumoniae • Mycoplasma salivarium • Mycoplasma spumans • Mycoplasma pi-Mycoplasma detection in hours, not days. It’s about time.

Acholeplasma laidlawii

Mycoplasma buccale

Mycoplasma fermentans

Mycoplasma gateae

Mycoplasma hyorhin

Mycoplasma molare

Mycoplasma salivarium

Mycoplasma auris

Mycoplasma canadense

Mycoplasma gallicum

Mycoplasma indiense

Page 16: Overcome Your Cell Culture, Purification, and Process ... · • Mammalian cell culture manufacturers are required to test for potential mycoplasma contamination; the current mycoplasma

MycoSEQ™ Mycoplasma Detection System

WHAT IS IT?

• An integrated sample preparation and real-time, quantitative PCR assay for the detection of mycoplasmas

in cell culture samples

• Complete system includes sample preparation, assay, and instrument

WHY IS IT IMPORTANT?

• Mammalian cell culture manufacturers are required to test for potential mycoplasma contamination;

the current mycoplasma test is a 28-day culture test

• The MycoSEQ™ Mycoplasma Detection System delivers actionable results in 5 hours, allowing for

valuable in-process testing during cell culture development

Contact your Applied Biosystems Sales Representative

www.microseq.com/mycoplasma

Page 17: Overcome Your Cell Culture, Purification, and Process ... · • Mammalian cell culture manufacturers are required to test for potential mycoplasma contamination; the current mycoplasma

Go molecular. The answer is in the DNA.

Page 18: Overcome Your Cell Culture, Purification, and Process ... · • Mammalian cell culture manufacturers are required to test for potential mycoplasma contamination; the current mycoplasma

MicroSEQ® Microbial Identification System

WHAT IS IT?

• Fastest and most accurate commercially available identification system for bacteria and fungi, based

on DNA sequencing of the 16S rRNA gene for bacteria or the D2 region of the large subunit for fungi

• Complete system includes sample preparation, assays, instrument, and software

WHY IS IT IMPORTANT?

• Harmful bacteria and fungi can contaminate raw materials, production facilities, and branded products

• Regulatory expectations include an active environmental monitoring program as part of cGMP

to identify bacteria and fungi at the species level

Contact your Applied Biosystems Sales Representative

www.microseq.com

Page 19: Overcome Your Cell Culture, Purification, and Process ... · • Mammalian cell culture manufacturers are required to test for potential mycoplasma contamination; the current mycoplasma

Residual host cell DNA quantitation. Precision counts.

Page 20: Overcome Your Cell Culture, Purification, and Process ... · • Mammalian cell culture manufacturers are required to test for potential mycoplasma contamination; the current mycoplasma

resDNASEQ™ CHO Residual DNA Quantitation System

WHAT IS IT?

• First integrated qPCR system for quantitation of CHO residual DNA with optional automated

sample preparation

• Complete system includes sample preparation, TaqMan® assay, genomic CHO standard, and instrument

WHY IS IT IMPORTANT?

• Regulatory expectation is that DNA content in the final product should be as low as possible, as

determined by a highly sensitive method

• The resDNASEQ™ CHO Residual DNA System delivers high DNA recovery and same-day results easily,

in <5 hours

Contact your Applied Biosystems Sales Representative

www.microseq.com

Page 21: Overcome Your Cell Culture, Purification, and Process ... · • Mammalian cell culture manufacturers are required to test for potential mycoplasma contamination; the current mycoplasma

Transform your downstream performance.

Page 22: Overcome Your Cell Culture, Purification, and Process ... · • Mammalian cell culture manufacturers are required to test for potential mycoplasma contamination; the current mycoplasma

POROS® Perfusion Chromatography Media

WHAT IS IT? • Best-performing chromatographic media for process-scale bioseparations

• Patented “throughpores” enable high-resolution separations with 2–3x the throughput of conventional

fast-flow gels

WHY IS IT IMPORTANT? • Helps overcome purification challenges for monoclonal antibodies and other biotherapeutic molecules

• Rigid and robust; easy to handle and pack

• Used in multiple FDA-approved therapeutics

Contact your Applied Biosystems Sales Representative

www.info.appliedbiosystems.com/poros

Page 23: Overcome Your Cell Culture, Purification, and Process ... · • Mammalian cell culture manufacturers are required to test for potential mycoplasma contamination; the current mycoplasma

Contact Information

Page 24: Overcome Your Cell Culture, Purification, and Process ... · • Mammalian cell culture manufacturers are required to test for potential mycoplasma contamination; the current mycoplasma

For research use only. Not for human or animal therapeutic or diagnostic use.

© 2009 Life Technologies Corporation. All rights reserved. Trademarks of Life Technologies Corporation and its affiliated companies: AB (Design)®, Advanced Granulation Technology™, AGT™, Applied Biosystems®, EfficientFeed™, GIBCO®, Invitrogen™, MediaExpress™, MicroSEQ®, OPtiCHO™, PD-Direct®, POROS®, resDNASEQ™, Revolution®. TaqMan is a registered trademark of Roche Molecular Systems, Inc. All other trademarks are the sole property of their respective owners.

Printed in the USA, 07/2009 Publication 128BR09-01 O-085463