Mammalian Cell Bank Characterization

To ensure the consistency of a therapeutic product, a uniform cell source is required each time a new production campaign is started. A critical component in controlling the production of biological products derived from human and animal cell lines is the characterization and testing of banked cell substrates. The objective is to confirm the identity, purity, and suitability of these cells for manufacturing use. The preparation of a cell bank needs to meet the standards of current good manufacturing practice (cGMP) and is one of the critical steps for the production of biopharmaceuticals. Its high quality is essential for the economical, reliable, and consistent manufacturing of the therapeutic product.

Major mammalian cell lines used in the biopharmaceutical industry as host cells for the production of biologics include Chinese hamster ovary (CHO) cells and mouse myeloma cells, including NS0 and Sp2/0 cells. Creative Bioarray provides comprehensive and detailed services for mammalian cell bank characterization to help our customers worldwide in the field of cell banks. We delivered rapid and accurate results to assist customers in accessing the quality of cell banks. Reliable, rapid, and accurate results will be delivered to assist customers in assessing the quality of cell banks.

Master and End-Of-Production Cell Bank Characterization and Testing

• Basic microbiology assay, including but not limited to sterility (bacteria and fungus), sterility GMP analysis, mycoplasma (points to consider in the characterization of cell lines used to produce biologicals), mycoplasma GMP analysis, bacteriostasis/fungi stasis, etc.

• Identity testing, including but not limited to morphological analysis, STR analysis, karyology, total viable cells/vial, cell viability (post-bank thaw), barcode analysis, isoenzyme electrophoresis, and DNA fingerprinting.
• Genetic stability assay, including but not limited to copy number determination, restriction map analysis, retention of a selectable marker, retention of recombinant construct, and DNA/RNA sequencing.
• Purity testing, such as in vivo adventitious viral agent detection including CHO, MRC-5, Vero detector line, tissue culture safety (in vitro adventitious viral agent detection), F-PERT assay, antibody production test, virology testing, retroviral testing (reverse transcriptase, S⁺L^- focus, XC plaque), Bovine and porcine viruses (only if bovine and porcine raw materials are used).
• Transmission electron microscopy (TEM) examination of cell cultures.
• Tumorigenicity testing and oncogenicity testing.

Working Cell Bank Characterization and Testing

• Cell line expansion.
• Sterility GMP analysis.
• Mycoplasma GMP analysis.
• Identity testing.
• In vitro adventitious agent CHO detector line.
• In vitro adventitious agent MRC-5 detector line.
• In vitro adventitious agent Vero detector line.
• Optional in vitro adventitious agent 324K detector line.

As a pioneer in biosafety testing service, Creative Bioarray provides cost-effective, high-quality, and hassle-free services to our customers worldwide. We offer international testing methodologies for mammalian cell bank characterization. We provide our clients with direct access to our experts and prompt responses to their questions. If you are interested in our services or have any questions, please feel free to contact us or make an online inquiry.