Xtalks — The Life Science Community™, Online webinar
2026-10-13
As AAV-based gene therapy programs move from late-stage clinical development toward commercialization, Chemistry, Manufacturing and Controls (CMC) execution often becomes a key determinant of launch readiness. This webinar will explore how process characterization, control strategy development, analytical readiness and Process Performance Qualification (PPQ) planning can come together while remaining scientifically sound, operationally practical and defensible in future regulatory interactions. For rare disease programs in particular, where timelines, material availability and patient need are especially constrained, avoiding late-stage CMC surprises is important. By leveraging prior process understanding, established analytical capabilities and structured CMC data, developers may be able to reduce duplicated effort, streamline process characterization and PPQ planning and improve predictability as programs approach BLA readiness. External benchmarking of AAV commercialization pathways has shown that CMC-related delays can materially affect time to approval, underscoring the value of early, risk-based planning and platform-informed execution. Attendees will learn how MSAT teams can help bridge development, manufacturing, analytics and regulatory strategy, turning process knowledge into actionable decisions that support PPQ readiness and efficient commercialization of AAV gene therapies. The featured speaker will discuss how a manufacturing platform with a fit-for-purpose MSAT strategy can support the transition from clinical manufacturing to commercial readiness for AAV products. The session will focus on the pre-PPQ activities that help establish a robust control strategy, including critical quality attribute definition, process parameter and performance attribute assessment, risk-based process FMEA, scale-down model qualification and process characterization study design. A client case study will illustrate key commercialization-enabling activities for an AAV program while protecting product-specific information. The discussion will also highlight the decision-making framework behind these activities, with illustrative examples of how process characterization outputs can inform safe operating ranges, set-points and control strategy decisions. Register for this webinar to learn how platform knowledge, process characterization and PPQ planning can help accelerate and de-risk AAV therapy commercialization.
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