Cell Line Characterization
Cell Line Characterization is required by the regulatory bodies to confirm the species origin and history of the cell line; and characterize and test the identity, stability and purity:
Identity – a required test to confirm the species of the origin and one of the following methods must be performed on a MCB and EOP/CAL
Genetic Stability – the assessment of the cell line across the production process and is typically performed using cells from MC B to compare cells from the EOPC/CAL.
Purity – this proves the absence of bacteria, fungi, mycoplasma, and viruses.
We recommend that Cell Line Characterization studies are carried out on both mammalian and non-mammalian cell lines at various stages of drug production, including:
- Cell Lines
- Working Cell Banks (WCB)
- Master Cell Banks (MCB)
- End-of-Production Cells (EOPC)
- Virus Seed Stock (VSS)
- Raw Materials & Final Products
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