This paper introduces scientific and technical perspectives and recommendations from industry peers including cell banking technical experts and regulatory representatives from across the globe, representing over 15 pharmaceutical companies. The paper proposes a risk-based scientific approach to qualifying replenishment working cell banks (WCBs) when they are manufactured with, and without, changes. A consistent technical approach to the qualification of replenishment WCBs by incorporating risk-based analysis enables appropriate planning, nimble operations and de-risks product supply for patients by preventing possible delays when replenishing WCBs.

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