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Cell Bank Characterization
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. Beckman Coulter Genomics offers a broad array of services in support of Genetic Stability Testing of cell banks producing Recombinant Proteins and Monoclonal Antibodies.
The Advantages Beckman Coulter Genomics 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
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:
- Confirmation of Structure Map
- Copy Number
- Insertion Site Number
- DNA Sequencing
- mRNA Sequencing
- Northern Blot Analysis
- Southern Blot Analysis
- QPCR
- Residual DNA testing
Bacterial Cell banks and other plasmid banks usually contain multicopy plasmid based expression systems. Specific services Include:
- Confirmation of Structure map
- Copy Number
- Phage Detection
- Marker Retention
- DNA Sequencing
- Southern Blot Analysis
- QPCR
- Residual DNA testing
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.
