In this free webinar, learn how next-generation sequencing (NGS) can support total potency assurance for adeno-associated virus therapies. The featured speaker will discuss how NGS-based testing can assess sequence purity and quantify sequence variants or vector sub-populations as part of a total potency assurance package. Attendees will also explore assay validation approaches that can support clinical development and commercial release.
TORONTO, Aug. 26, 2026 /PRNewswire/ — Demonstration of therapeutic potency is critical for successful development and commercialization of viral-vector based products. In fact, the potency assay is one of the most critical cornerstone assays for successful clinical programs.
However, depending on the intended indication, in vivo-based potency assays may be difficult to design and implement successfully. In these instances, a total potency assurance strategy may be used to infer potency indirectly. This webinar explores how next-generation sequencing can support potency assurance using adeno-associated virus as a model.
Total potency assurance assays focus on the Critical Quality Attributes (CQA’s) for the specific type of molecule being assessed and combine multiple assays which serve different functions. For example, a total potency assurance package may include assays for particle assessment, nucleic acid assessment, functional titer and many other applications.
The featured speaker will introduce how a Next Generation Sequencing (NGS) based approach can be integrated into a total potency assurance package using AAV as a model. The speaker will demonstrate NGS’s ability to serve as a sequence purity assay and how quantitation of sequence variants, or vector sub-populations, can be achieved with suitable precision and accuracy. Finally, the webinar will present data to support the validation of such an assay as a quantitative assessment suitable for phased trials and commercial release in accordance with parameters consistent with ICH Q2(R2), and an approach to product-specific validation which has been accepted within the context of regulatory filings.
Register for this webinar to learn how potency assurance can incorporate NGS-based sequence purity testing to support AAV therapy development, validation and commercial release.
Join Rebecca Bova, PhD, Senior Scientist, Head of CNAT (Custom NGS Assays Team), MilliporeSigma, for the live webinar on Wednesday, September 23, 2026, at 11am EDT (5pm CEST / EU-Central).
For more information, or to register for this event, visit Strengthen Total AAV Potency Assurance with NGS Sequence Analysis.
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