Cell banking is the process of preparing, characterizing, and storing cell stocks under cryopreservation conditions to ensure a consistent and traceable supply of starting material throughout the lifecycle of a biopharmaceutical product. It involves the establishment of a Master Cell Bank (MCB) and a Working Cell Bank (WCB), both of which must meet GMP standards and be qualified through safety, identity, and purity testing in accordance with ICH Q5D guidelines.
