Cell Line Characterization
Cell line characterization is required by regulatory bodies to confirm cell line species origin and history, as well as characterize and test cell line identity, genetic stability, and purity.
Identity - This required test confirms the species of origin and one of the following methods must be performed on a Master Cell Bank (MCB) and End-of-Production/Cells at Limit (EOP/CAL).
Genetic Stability – This cell line assessment is completed across the production process; typically performed using cells from MCB to compare cells from the EOP/CAL.
Purity – This test is used to detect a range of possible contaminants, including bacteria, fungi, mycoplasma, and viruses.
We recommend cell line characterization studies are carried out on both mammalian and non-mammalian cell lines at various stages of drug development and production, including:
- Cell Lines
- Master Cell Banks (MCB) and Working Cell Banks (WCB)
- Adventitious viruses (in vitro and in vivo testing)
- Retroviruses
- MAP/HAP/RAP assay panels
- End-of-Production Cells (EOPC)
- Virus Seed Stock (VSS)
- Raw Materials & Final Products
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