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+44 (0)141 946 9999

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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.

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