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💬 Q&A with Experts | Gene Therapy Method Validation – CMC Focus | March 2025

In this episode of our “Ask the Experts” series, Victoria answers a crucial question in gene therapy manufacturing:
When should analytical methods be qualified or validated across clinical development?

🚀 Whether you're preparing for Phase 1 trials or approaching commercialization, knowing when and how to validate your methods is key for a successful regulatory journey.

🔍 In this session, you'll learn:
✅ The difference between compendial and non-compendial methods
✅ US vs. EU regulatory expectations for method qualification
✅ Which methods must be qualified/validated at each phase (dose-determining, safety, potency, etc.)
✅ EMA’s approach to ensuring methods are “fit for purpose” early on
✅ The importance of validation protocols and supporting data

This session is a must-watch for teams working on CMC strategy in gene or cell therapy!

📥 Submit your questions for future Q&A episodes.

#GeneTherapy #CellTherapy #MethodValidation #CMC #AskTheExperts #FDA #EMA #RegulatoryAffairs #Biotech