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Advancing Purity in AAV Gene Therapy: Strategies for Minimizing and Clearing Empty Capsids

18 Sep 2025
Gene Therapy CMC & Process Development
  •  Challenges posed by product-related impurities like empty capsids on safety, efficacy, and regulatory expectations.
  • Emerging technologies and process controls that enhance full-to-empty capsid ratios during AAV production.
  • Approaches to selectively clear empty capsids while preserving yield and ensuring downstream purity
Industry Expert
James Warren, SVP, Global CMC Development - Ultragenyx