The preparation and validation of stock cultures of mammalian cells.

The utilization of continuous cell substrates is now widely accepted for the production of biologics. As part of the evaluation and licensing process of these products, the regulatory agencies are requiring extensive validation of the production system. That production system begins with the validation or qualification of a defined cell bank. This includes the validation of the stability cells at both the genetic and biochemical levels during cell culture production. Process validation plus cell bank validation provide the necessary assurance that the final product will be free of contaminating viruses and other adventitious agents. A combination of cell bank characterization and product characterization (peptide mapping or amino acid sequencing, or a combination thereof) will also demonstrate the stability of the production process. The validation of a cell bank for adventitious agents and cell line stability will not, in itself, ensure that the product is sterile and stable. However, cell bank validation is critical for demonstrating the safety of a product when combined with both process validation and end-product testing.