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A system whereby successive final lots (batches) of a product are manufactured by culture in cells derived from the same master cell bank (master cell seed). A number of containers from the master cell bank master cell seed) are used to prepare a working cell bank (working cell seed). The cell-bank system (cell-system) is validated for the highest passage level or number of population doublings beyond that achieved during routine production.
Publication Source: Rules and Guidance for Pharmaceutical Manufacturers and Distributors. Medicines Control Agency (MCA)
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