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
Use the form below to contact our experts about your cell line characterization needs.
Related Resources
- Technical Note: SARS-CoV-2 Impact To Biological Drug Products Safety
This technical note is comprised of a review of currently available literature and our recommended SARS-CoV-2 virus detection test methods and susceptibility of common biological host cells to infection.
- Infographic: Cell Line Preparation for Optimal Production
In this infographic, we show the 3 main steps for optimal cell line preparation that will give you peace of mind for your production process.
- Flyer: Cell and Virus Bank Development, Characterization, and Storage You Can Count On
We ensure your cell lines are produced and maintained for optimal production.
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