Safc Biosciences - Development Services

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Process Development

Research

Development Services Everything you need – at every stage of development

www.safcbiosciences.com

Member of the Sigma-Aldrich Group

Taking the guesswork out of cell line development

Trust SAFC Biosciences to accelerate the pre-clinical stages of your development processes.

Cell Xpress™ Clone Selection

Molecular Biology Consultation and Services

Absolute: Analyze, select, document and perpetuate only the clones that meet your development criteria in just weeks, cutting cell line development timelines in half.

Wisdom: Choose SAFC Biosciences and expect high performance products, services and information – all designed to enable you to quickly select the best possible option to meet your research goals.

• Technology for single-cell cloning of the most productive clones in a population

• Expression feasibility

- Increase specific productivity and titer

- Secretion assessment - Expression strategies

- Stabilize cell line genetic drift

• Transfection optimization

- Create clones that are more uniform in productivity

- Improved methodology - Optoinjection

Extend your capabilities with a full line of development services

Molecular Biology Consultation and Services

Gene of Interest

Media Optimization and Adaptation

Process Development

Scale-up & Validation Studies

time

Clone Selection (Cell Xpress™)

Stability Assessment

Process Feasibility

Product

Responsive Expertise SAFC Biosciences is the world’s leading supplier of cell culture reagents to producers of marketed biological products. We are committed to supplying high-quality critical raw materials and specialized cell culture products and services to the global health care industry. By providing the broadest range of highly customized products and services possible to cell culture-based manufacturing companies we demonstrate our commitment to being responsive experts.

Facilitate decisions with feasibility analysis

Cut cell line development in half with Cell Xpress™

Meet your research goals Add control to your biological processes

Benefit from 35 years' experience in media optimization

Achieve consistent development results through stability assessment

Increase your specific productivity and titer with Cell Xpress™ Cell Line Development

Parental Cell Line

Commercial cell line pre-Cell XpressTM

Cell Xpress™ clone

Commercial cell line 50 doublings post-Cell XpressTM

Medium Optimization and Adaptation

Stability Assessment

Proven: Benefit from over 35 years’ expertise in successfully optimizing media component composition for increased productivity and overall robustness in the cell culture process.

Consistent: As your chosen manufacturer and supply partner, we understand that material and processes must be carefully and proactively managed to ensure consistent performance and manage product risk.

• Statistical Approaches - Mixture experiments - Factorial matrices - Central composite designs • Rational Design Approaches

• Cell line stability - Generational consistency studies - Visual analysis of clone performance at any stage • Media stability

- Spent medium analysis (amino acids, glutamine, lactate, etc.)

- Fresh and spent media analysis

- New assay development (vitamins, fatty acids, biomarkers, trace elements, peptide mapping, etc.)

- Experience with serum-free, animal-component free, protein-free and chemically defined media formulations • Component analysis

Using our computer-aided cell screening, photographic analysis, laser-based selection and rapid media optimization techniques, you will find we remove any need for guesswork.

Process Development

Scale-Up and Validation

Powerful: Harness our scientific, technical and commercial knowledge for scaleable, application-tested cell culture solutions for expression of your proteins.

Simple: SAFC Biosciences adds control to biological processes through customized projects and investigations of all potential sources of performance or quality variation.

• Bioreactor scale feasibility

• Extensive library of cell culture products

- Process control - Development of bioreactor processes - Feed strategies - Value-added feeds/supplements (optimized hydrolysates) - Contract projects • Feed development - Amino acids - Vitamins

- Consistent performance - Scaleable • Quantification of components in fresh or spent media • Monitoring productivity during process optimization • Characterizing product quality • Customized assays • Upstream & downstream biological buffers

- Hydrolysates - Productivity inducers • imMEDIAte ADVANTAGE™ - 10-day turnaround on custom media formulations - Standardized raw materials - Mirrors manufacturing methods in large-scale cGMP facilities

Facilitate decisions with feasibility analysis

Contact us United States SAFC Biosciences, Inc. 13804 W. 107th Street Lenexa, Kansas 66215 USA Tel: +1 913-469-5580 Toll Free – USA: 1 800-255-6032 Fax: +1 913-469-5584 E-mail: [email protected]

Europe SAFC Biosciences Ltd. Smeaton Road, West Portway Andover, Hampshire SP10 3LF UNITED KINGDOM Tel: +44 (0)1264-333311 Fax: +44 (0)1264-332412 E-mail: [email protected]

Asia Pacific SAFC Biosciences Pty. Ltd. 18-20 Export Drive Brooklyn, Victoria 3025 AUSTRALIA Tel: +61 (0)3-9362-4500 Toll Free – AUS: 1 800-200-404 Fax: +61 (0)3-9315-1656 E-mail: [email protected]

imMEDIAte ADVANTAGE™ is a trademark of SAFC Biosciences, Inc. Cell Xpress™ is a trademark of Cyntellect. © 2007 SAFC Biosciences, Inc. Issued January 2007 G055

www.safcbiosciences.com

Member of the Sigma-Aldrich Group

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