Cell banks and, where appropriate, seed banks, are a store of the biological starting materials used in the production of biopharmaceutical products. A cell bank is manufactured to cGMP (current Good Manufacturing Practice) and are thoroughly tested and characterized to understand and document their properties. In-depth characterization of cell banks are beyond the routine quality control tests that ensure the identity, purity and stability. The more complex testing requirements exist in guidance on the characterization and qualification of cell substrates.
As the cell banks and seed banks are the source of all future batches of a biopharmaceutical product these banks must be stored under secure and controlled conditions for the lifetime of the product. GRA can provide help in guiding the manufacturing, characterization and selection of off-site storage facilities.
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