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E. coli purity testing

To ensure the purity and safety of the cell bank, it’s necessary to design and implement a comprehensive testing program based on a thorough, accurate risk assessment. As part of this assessment, it’s important to consider the type of cell bank that has been prepared, as the rationale for testing differs depending on the type of cell bank that is produced. For example, the testing program for a non-production cell bank (cells used for analytical assays) or for seed cells that are expanded to create a MCB is typically much more abbreviated than the testing program implemented for a production cell bank.