Cell banks are the critical components in the biopharmaceutical industry. Hence, prior to evaluating the biosafety of cell-derived products, it is essential to perform a comprehensive characterization analysis in order to guarantee the purity and safety of the cell banks. A well-characterized cell bank provides a reliable source of contaminant-free production. As described in the FDA, ICH and EMEA guidelines, the recommended assays are partially different depending on the type of producing cell bank.
The biosafety package for any biopharmaceutical product must include an appropriate and speciﬁc plan for evaluation the cell line identity and its recombinant genome stability as well as detection of endogenous and adventitious agents such as bacteria, mycoplasma, fungi or viruses. These cell bank characterization services enable production of biologicals free of molecular, cellular, and viral safety assays for the mammalian, insect, and microbial cell lines at the level of the Master, Working, and End of Production Cell Banks. in the following page, the recommended tests will be listed according to the ICH guidelines and Pharmacopeia.