Cell and Virus Characterization
The regulatory requirements for a cell line or virus seed characterization program have three major components:
- Source history and generation of the cell line or virus seed
- Characterization and testing to establish identity, purity and stability
- Cell banking or virus seed 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 laboratory practice (cGLP) 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.
BioReliance has manufactured and characterized hundreds of client cell banks and offers a complete testing program covering the identity and homogeneity, purity and stability. Programs are custom designed to take into account the species of origin and culture history of the cells.
