Navigating Global Comparability Expectations in Cell & Gene Therapy CMC Development
Time: 1:30 pm
day: Conference Day Two
Details:
- Harmonizing comparability approaches: contrasting FDA, EMA, and agencies such as Health Canada, ANVISA (Brazil), and CDE (China) to understand their impact on CMC strategy
- Risk-based frameworks for comparability assessment: leveraging analytical tools, potency assays, and totality-of-evidence to manage complex modality changes
- Proactive regulatory engagement: best practices for early discussions, submission planning, and addressing post-approval manufacturing evolution
