Molecular Diagnostics Services, Inc.
A Contract Research Organization

Cell Bank Qualification

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:

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.

Submission Form
Mammalian Cell Bank Characterization Form (YY)


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