The challenge of demonstrating potency in adeno-associated virus (AAV) therapies often forces developers to rely on indirect inference strategies. Rather than depending on a single, difficult-to-design in vivo test, a robust potency assurance package combines multiple assays to evaluate critical quality attributes, including particle concentration, nucleic acid integrity, and functional titer.

Rebecca Bova, head of the Custom NGS Assays Team at MilliporeSigma, will detail how NGS-based approaches provide the precision necessary to assess sequence purity and quantify specific vector sub-populations. The discussion will cover the validation of these quantitative assays, aligning with ICH Q2(R2) parameters to ensure they meet the rigorous standards required for regulatory filings and eventual market release. The session is scheduled for September 23, 2026, at 11am EDT.