Accelerating AAV Therapy Commercialization: Insights from Xtalks Webinar

The upcoming webinar titled "From Platform Knowledge to Commercial Readiness: Accelerating and De-risking your AAV Therapy's Path to Patients," hosted by Xtalks, is set to provide valuable insights into the transition of adeno-associated virus (AAV) therapies from developmental stages to market readiness. Taking place on October 13, 2026, this session promises to be an invaluable resource for stakeholders involved in gene therapy.

Importance of Early CMC Planning

As AAV-based gene therapies progress towards commercialization, effective Chemistry, Manufacturing, and Controls (CMC) execution emerges as a critical factor determining their launch readiness. During this free webinar, participants will learn the nuances of process characterization, control strategy development, and Process Performance Qualification (PPQ) planning. These steps are crucial to ensure that AAV therapies not only meet regulatory requirements but are also manufactured safely and effectively.

The session will feature Isabel Guerrero, a Senior CMC Scientist at Viralgen, who will delve into the significance of preparing for PPQ by establishing a robust control strategy. This includes defining critical quality attributes and assessing process parameters, ensuring that the therapies produced are both safe and effective.

Bridging Development and Manufacturing

One of the key focuses of this webinar will be how Manufacturing Science and Technology (MSAT) teams can bridge the gaps between development, manufacturing, analytics, and regulatory strategies. By turning process knowledge into actionable decisions, MSAT teams play a crucial role in ensuring the efficient commercialization of AAV therapies.

The discussion will also address process characterization and how it can inform essential aspects such as operating ranges and control decisions. This is especially important for rare disease programs where the need for timely therapies is paramount. Attendees will learn how to avoid late-stage CMC surprises that could delay critical approvals.

Reducing Risks Through Platform Knowledge

By leveraging prior process understanding and structured CMC data, developers can streamline their planning, reduce duplicated efforts, and improve predictability in the lead-up to Biologics License Application (BLA) readiness. The webinar will highlight how external benchmarking of AAV commercialization pathways has shown that delays related to CMC can materially impact the overall timeline to approval.

With a focus on real-world applications, the session will include a client case study that illustrates key commercialization-enabling activities for an AAV program while safeguarding product-specific information. This case study will demonstrate how existing knowledge can facilitate a smoother transition from clinical manufacturing to commercial readiness.

Registration and Event Details

Interested participants are encouraged to register for the webinar to gain insights on how platform knowledge, process characterization, and PPQ planning can help accelerate and de-risk the commercialization of AAV therapies. The free live session will take place on Tuesday, October 13, 2026, at 11 AM EDT (5 PM CEST).

For more information and to secure your spot, visit the Xtalks website. This event promises to enrich your understanding of CMC strategies and their importance in the fast-evolving field of gene therapy.

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