Abstract
The significant differences between source materials for chemical drugs and biologics are evaluated. Furthermore, the CMC regulatory compliance requirements for each type of biologic source material—cell banks, virus seed banks, and transgenic seed/animal banks—are thoroughly discussed in this chapter. Finally, four myths about biologic cell banks are debunked: (1) must have both a Master Cell Bank and a Working Cell Bank, (2) a phase 1 clinical stage Master Cell Bank is perfectly acceptable for commercial use, (3) multiple Master Cell Banks during clinical development are not a major risk, and (4) Working Cell Banks rarely cause problems.
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