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:
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