ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Master Cell Bank (MCB)

(ICH Q5A (R1)/Q5B/5QD) An aliquot of a single pool of cells which generally has been prepared from the selected cell clone under defined conditions, dispensed into multiple containers and stored under defined conditions. The MCB is used to derive all working cell banks. The testing performed on a new MCB (from a previous initial cell clone, MCB or WCB) should be the same as for the MCB, unless justified.

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