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Cell Bank Characterization
Good Laboratory Practices & current Good Manufacturing Practices
Regulatory approval of recombinant products requires rigorous analysis to demonstrate the culture is
pure, the cells are stable and the recombinant DNA gene expression system is intact. Genetic stability
testing of cell banks is a key component in the analysis required to maintain quality assurance of a
production cell line. Cogenics offers a broad array of services in support of Genetic Stability Testing
of cell banks producing Recombinant Proteins and Monoclonal Antibodies.
The Advantages of Using Cogenics for Your Genetic Stability Testing
- Performed greater than 2000 projects in supporting IND submissions and BLA filings for cell line
characterization for bulk and final product testing
- Successful track record in offering custom assay validation according to ICH guidelines
- Dedicated study director is the primary point of contact to ensure project goals are met
- Full adherence to relevant regulations and guidelines, designed to support both preclinical and clinical needs
- Over 17 year of experience in offering regulated services in support of GST
Genetic Stability Testing Services for MCB, WCB and EPC banks
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Mammalian Cell Banks and other integrated banks include analysis of the chromosomally inserted
expression system and the mRNA transcript that encodes the gene product. Specific services Include: |
Bacterial Cell banks and other plasmid banks usually contain multicopy plasmid based expression
systems. Specific services Include: |
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Regulatory services are designed to support both preclinical and clinical needs, with full
adherence to relevant regulations and guidelines including CFR Title 21 Part 58 for GLP, CFR
Title 21 Part 210 and 211 for GMP, and CFR Title 21 Part 50 and ICH E6 for GCP.
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