A Master Cell Bank (MCB) is a characterized and cryopreserved collection of cells derived from a single clonal cell population, stored in multiple aliquots under defined cryopreservation conditions, that serves as the primary reference source for all subsequent manufacturing activities throughout the product lifecycle. The MCB must be fully characterized for identity, purity, viability, genetic stability, and absence of adventitious agents in compliance with ICH Q5D guidelines and GMP requirements. It is used to generate the Working Cell Bank (WCB), from which individual manufacturing runs are initiated.
