Cell Banking and Characterization
We offer capabilities to prepare and characterize a wide variety of mammalian, human and insect cell banks, including master, working, research, bioassay, and ready-to-use cell banks.
Cell bank production is supported by a comprehensive package of cGMP safety testing services including microbiology, mycoplasma, genetic stability, viral safety, and biochemistry.
Cell line testing is performed on all Research Cell Banks (RCB), Master Cell Banks (MCB), Working Cell Banks (WCB), and Limit of In Vitro Cell Age (LIVCA), or End of Production (EOP) cells in accordance with global regulations. This ensures the identity, purity, and safety of the cells and resulting biopharmaceutical product.
MCB and EOP testing require the most extensive testing, including exogenous and endogenous viruses, and microbial contaminants. WCB testing is performed to ensure that the bank is free from adventitious agents (i.e., bacteria, viruses, mycoplasma, fungi) that may have been introduced in production of the WCB.
Viral bank manufacturing requires a list of testing very similar to traditional biologics; however, there are several considerations with viral bank testing. If the virus interferes with cell-based virology test methods NexGen sequencing can be performed. Similarly, NexGen sequencing can be considered for identity testing of viruses. Residual plasmid testing qPCR will also need to be performed.
With the approval of Q5A(R2), new methods for biosafety testing are being introduced, such as 14-day in vitro adventitious agent testing, rapid mycoplasma qPCR methods, NexGen sequencing. FDB is actively establishing these methods in support of rapid unprocessed bulk (UPB) testing for CHO and viral products.
Facilities
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