Cell Bank Qualification

CELL LINE CHARACTERIZATION AND VIRAL SAFETY TESTING
Before evaluating the biosafety of cell-derived products, manufacturers need to check and to guarantee the origin of the cells used, as described in the FDA and EMEA guidelines. Since 1992, MDS has been providing comprehensive services for Release Package [GMP Support], evaluating cell banks, raw materials and cell derivatives such as monoclonal antibodies, recombinant proteins, vaccines and gene therapy products for our national and international clients. All tests are conducted and documented in compliance with Good Laboratory Practices, 21 CFR 58 and in accordance with the EU or US Pharmacopoeia and EMEA or FDA guidelines such as:

• Good Laboratory Practices for Non-Clinical Laboratory Studies, 21 CFR 58. US Food and Drug Administration.
• U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research. Points to Consider in the Characterization of Cell Lines used to Produce Biologicals (1993).
• Guidance for Industry: Characterization and qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and treatment of Infectious Diseases: February, 2010. 
• ICH Harmonized Tripartite Guideline: Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin; Q5a (R1): 23 September 1999.
• International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Q5A/Q5B.
• ICH Guidance, Q5D: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products, (63 FR 50244; September 21, 1998).

Three cell banks are generally examined: the master cell bank (MCB), the working cell bank (WCB) and the end-of-production cell bank (EPCB) or cells at the age limit of in vitro culture.
The tests carried out depend on the origin of the cells in question.

• Typical Mammalian Cell Line
• Typical Microbial Cell Line
• Typical Yeast Cell Line
• Typical Insect Cell Line

Submission Form
Mammalian Cell Bank Characterization Form (YY)