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Strategic CMC Frameworks for Gene Therapy: Regulatory Readiness from Development to Commercialization

18 Sep 2025
Gene Therapy CMC & Process Development
  • Building Robust CMC Strategies for Complex Modalities
  • Insights into proactive agency interactions and navigating evolving regulatory expectations across key markets.
  • Balancing speed with compliance—innovations in manufacturing and analytical control strategies for clinical and commercial readiness
Industry Expert
Rashi Srivastava, Head of CMC Regulatory Affairs, Cell & Gene Therapies - Astra Zeneca