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Cell banks used to manufacture biopharmaceutical products must be established and characterized. Since 1981, thousands of cell lines have been characterized at BioReliance. Cell line characterization includes testing of cell culture medium supplements and materials, characterization of the Master Cell Bank (MCB), the Working Cell Bank (WCB) and the Cells at the Limit of in vitro Cell Age Used for Production or End-of Production Cells (EOP), and assay validation. Testing prebanking material is recommended for several reasons. First, it is used to ensure the microbiological suitability of the cell bank material as a substrate for the production of a master cell bank (MCB) and a working cell bank (WCB). Second, testing prebanking material protects the cell banking facility from exposure to adventitious bacterial and fungal contaminants. Finally, cell banking material that originates from a pre-existing, vialed bank should be evaluated in accordance with ICH Q5D. Final containers (1% of the bank or a minimum of two vials) are tested individually for the presence of bioburden.