QC playbook for CGT teams moving from early development → clinical → commercial, with phase-appropriate expectations with regulatory and CAPA management focus
This paper provides a practical roadmap to structure a QC program for cell and gene therapies from early development to commercial stage, with a focus on each phase specific requirements in term of testing (development / qualification / validation), documentation, and risk-based strategy.
It summarizes key regulatory expectations and offers a checklist-style approach to help teams anticipate common pain points (comparability, potency strategy, microbiological controls, and viral safety).
