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The characterization and safety testing of cell substrates are the first steps in ensuring the safety of biopharmaceutical products. The objective of characterization is to confirm the identity and purity of the cell to be used for production. The tests for purity also include testing for adventitious agents which could potentially contaminate the biopharmaceutical product. All of the tests required to demonstrate the suitability of the cell line must be performed to GMP standards using validated test procedures and according to the following international guidelines:
- Q5A (Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin - 1997)
- Q5B (Quality of Biotechnological Products: Analysis of the expression construct in cells used for production of r-DNA derived protein products - 1995),
- Q5D (Quality of Biotechnological Products: Derivation and characterization of cell substrates used for production of biotechnological/biological products - 1997),
- "Points to Consider in the characterization of cell lines used to produce biologicals" (FDA, CBER, 1993),
- European Pharmacopoeia (EP) and United States Pharmacopoeia (USP).
There are normally two cell banks that are produced, the master cell bank and the working cell bank. In addition to testing of the cell banks, the post production or end-of-production cells. Each cell bank requires a different testing regime. Bulk harvests must also be tested for purity. The test regime used for the cell line characterization and safety testing depends upon the specific cell line, e.g. prokaryotic or eukaryotic. In addition, each species of cell used for production may require a different test regime. The following table provides an examples of test regimes for the characterization of prokaryotic and eukaryotic cell lines.
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