Cell Bank Characterization
The pivotal step to ensure the safety of the biopharmaceutical product is to perform characterization and biological safety testing of the cell line. The international regulatory guidelines such as ICH (Q5A, Q5B, Q5D), EP and USP for the characterization of cell lines are focused on 3 major aspects :
- The source history and generation of the cell line
- Characterization and testing to establish Identity, Purity and Genetic Stability of the cell line; and
- The banking procedures of the cell line.
Characterization of cell bank is essential to ensure the safety of cell-derived biopharmaceutical products. The objective is to confirm identity, purity, genetic stability and tumorigenicity of the cell lines. Such characterization could ensure the source of cell line is authentic and safe from contamination from undesired cells and adventitious agents such as bacteria, fungi, mycoplasma, mycobacteria and virus. Generally source of cells at different stages, Virus Seed, Master Cell Bank, Working Cell Bank, End of Production Cell, Unprocessed Bulk, Purified Bulk, and Final Product all require different regimes of tests to ensure their safety.
TFBS Bioscience works closely with our clients to develop and design cost effective, scientifically sound, and validated testing methods for the characterization of cell lines. At TFBS, we offer our clients testing service with an accurate, prompt, and most efficient nature for your time-sensitive projects. From preliminary testing of seed stocks to rigorous Cell Bank Characterization, TFBS Bioscience ensures to meet your requirement in compliance to GLP and international regulatory guidelines.
| Mammalian Cell Bank Characterization | Bacterial and Yeast Cell Bank Characterization | |
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| Identity Assays |
(Random amplified polymorphic DNA) |
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| Purity Assays |
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| Stability Assays |
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| Other Assays |
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