Cell Line Characterization
BioReliance CRO’s cell line characterization services enable production of biologicals free of molecular, cellular, and viral contamination. We offer a wide variety of cell line characterization services including:
- Cell line authentication (Isoenzyme Analysis, Karyotyping, DNA Analysis, RAPD, Tumorigenicity, Oncogenicity)
- Genetic stability (cell lines and cell banks: FISH, DNA sequencing)
- Virology testing (adventitious virus, in vivo and in vitro assays, 9 CFR, transmission electron microscopy, MAP test)
- Cell line purity (mycoplasma, mycobacterium, sterility assays)
- Oncogenicity and tumorigenicity
We suggest performing cell line characterization studies on both mammalian and non-mammalian cell lines for our customers in various stages of drug production including:
- Cell lines
- Working cell banks
- Master cell banks
- End-of-production cells (EOPC)
- Virus seed stock
- Raw materials and final products
Custom services also are available. Contact BioReliance and our research team will be happy to assist you in planning your cell line characterization studies. Below you will find more information about the regulatory guidelines we support.
Regulatory Guidelines for Cell Characterization
BioReliance CRO scientists will assist you in designing your cell line characterization studies in compliance with global current Good Manufacturing Practice (cGMP), Good Laboratory Practice (GLP) practices as well as FDA and international regulatory guidelines.
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
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. Programs are custom designed to take into account the species of origin and culture history of the cells.