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Cell Line Characterization is a series of tests intended to confirm the identity and purity of the cell substrate. The testing must also verify the absence of cross-contamination and determine if the cells are prone to genetic instability.
All regulatory requirements for cell line characterization have three major components:
- Source history and generation of the cell substrate
- Characterization and testing to establish identity, purity and stability
- Cell Banking procedures
To ensure the quality and integrity of data derived from cell bank characterization and testing, laboratory studies designed for characterization of banked cells must comply with current good manufacturing practice (GLP) regulations for nonclinical studies including the U.S. Food and Drug Administration’s Good Laboratory Practice Regulation, the United Kingdom’s Good Laboratory Practice, and Japan’s Good Laboratory Practice Standard. If the product is to be marketed internationally, then initial efforts should be placed on developing cell line characterization and testing programs that satisfy regulatory requirements and recommendations of the U.S. Food and Drug Administration (FDA), the European Medicines Evaluation Agency (EMEA), and the Japanese Ministry of Health and Welfare. This foresight will alleviate the need for repeated and/or additional testing at the time of product license application submission. BioReliances’ Regulatory Affairs section can offer advice and assistance with regulatory issues.
BioReliance has established and characterized over 300 client cell banks, and offer a complete testing program covering identity and homogeneity, purity and suitability for use. Programs are custom designed to take into account the species of origin and culture history of the cells.
Tests include:
- Sterility and mycoplasma testing
- Isoenzyme analysis
- In vitro and in vivo assays for adventitious viral contaminants
- PCR and Q-PCR assays
- Retroviral infectivity assays, and more
Our scientists are experts in cGMP, cell bank production and characterization. Additionally a single point-of-contact is assigned to your program, keeping things simple, focussed and accessible at all times.
IIf you would like more detailed information, or have a specific query, please contact us at info@bioreliance.com or complete the form below.
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