Enhancing Total AAV Potency Assurance Through NGS Sequence Analysis Webinar

Unlocking the Future of AAV Therapies with NGS Sequence Analysis

In the ever-evolving domain of biopharmaceuticals, establishing therapeutic potency is crucial for the successful development and launch of viral-vector-based products, particularly adeno-associated virus (AAV) therapies. To address this need, Xtalks is hosting a free webinar titled "Strengthen Total AAV Potency Assurance with NGS Sequence Analysis" on September 23, 2026. This engaging event will delve into the role of next-generation sequencing (NGS) in enhancing total potency assurance, ensuring that product development not only meets regulatory standards but also achieves clinical success.

The Importance of Potency Assays

For any biopharmaceutical product, especially those utilizing viral vectors, potency assays serve as the backbone of quality assurance. These assays provide the necessary evaluation of a product's effectiveness and safety, making them essential for navigating the complex landscape of clinical trials and regulatory approvals. The potency assay is recognized as one of the most critical cornerstone assays within the clinical programs that underpin the success of AAV therapies.

In practical terms, however, designing effective in vivo potency assays often presents significant challenges. Understanding the specificities of the indication and the complexities of biological systems can hinder successful implementation. This is where a total potency assurance strategy comes into play, providing a framework to infer potency indirectly when direct measurement proves challenging.

NGS as a Game Changer

The webinar will feature detailed presentations on how NGS can be integrated into a comprehensive potency assurance package. The focus will be on leveraging NGS not only as a sequence purity assay but also for quantifying sequence variants and vector sub-populations with high precision. The featured speaker, Dr. Rebecca Bova, a Senior Scientist at MilliporeSigma, will share insights on varying assay validation approaches that can facilitate both clinical development and commercial release.

A total potency assurance approach incorporates various Critical Quality Attributes (CQA's) specific to the molecule being assessed, combining different assays for particle assessment, nucleic acid evaluation, and functional titer, among others. By bringing these diverse methodologies together, the result is a cohesive framework that can effectively ensure product quality and compliance with regulations such as ICH Q2(R2).

A Rich Learning Experience Awaits

This webinar promises not only to highlight the mechanics of NGS but also showcase data supporting its validation as a robust quantitative assessment method suitable for phased trials and subsequent market release. Participants will have the chance to learn how NGS-based sequence purity testing can significantly bolster the development of AAV therapies and their subsequent commercial viability.

Register for the Webinar

Don't miss out on this opportunity to elevate your understanding of potency assurance in AAV therapies. To register for the live webinar hosted by Xtalks, simply visit the official registration page. The session is set to take place at 11 AM EDT (5 PM CEST) on September 23, 2026. This event not only caters to those directly involved in the development of AAV products but also appeals to a wider audience interested in advancements in biopharmaceutical potency assurance methods.

Xtalks has established itself as a vital platform for life science professionals by providing reliable insights, industry updates, and engagement opportunities through webinars, articles, podcasts, and expert interviews. Whether you are a researcher, a pharmaceutical executive, or someone interested in the future of gene therapies, this webinar will provide valuable knowledge that fosters informed decisions in your respective fields.

For further information, or to explore more about how Xtalks is facilitating critical discussions in the life sciences, visit www.xtalks.com. Your insight today could pave the way for the therapeutic innovations of tomorrow.