USP Standards to Support AAV Quality Testing and Analytical Characterization of AAV Content Utilizing Mass Photometry and Orthogonal Techniques

Learn about United States Pharmacopeia (USP) standards for adeno-associated virus (AAV) quality testing and analytical characterization through this comprehensive webinar featuring three industry experts. Discover how USP has developed the first gene therapy reference materials specifically designed to support AAV stakeholders throughout the entire process from raw material qualification to product release. Explore the critical challenges in AAV testing, particularly capsid content attributes (empty-full ratios), and understand how reference standards address the need for harmonized best practices across the rapidly growing gene therapy field. Examine USP's newly available AAV reference materials that support empty/full assessment, capsid titer, genomic titer, residual plasmid quantification, endonuclease activity, and plasmid topology testing. Gain insights into Pharmaron's strategic approach utilizing mass photometry for rapid process development and in-process controls during large-scale AAV manufacturing, including comparative analysis with other orthogonal techniques used throughout the AAV manufacturing process. Understand how these standardized approaches help ensure consistent method performance and address the metrological challenges posed by the variety of test methods currently used in AAV characterization.