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

Contact us to speak to our expert technical team about your Cell Line Characterization study, as well as any custom needs.