From Platform Knowledge to Commercial Readiness:
Accelerating and De-risking your AAV Therapy’s Path to Patients
About this webinar
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.
Who should attend
- Therapeutic developers using AAV in the
manufacture of cell and gene therapies - CMC professionals
- MSAT scientists and leaders
- Process Development Scientists
- Manufacturing Scientists and Engineers
What you will learn
- How platform knowledge can reduce duplicated effort and support more efficient AAV commercialization
- How MSAT teams can connect development, manufacturing, analytics and regulatory strategy as programs approach PPQ
- The pre-PPQ activities required to establish a robust control strategy, including critical quality attributes, process parameters, FMEA and scale-down model qualification
- How process characterization data can inform safe operating ranges, set-points and control strategy decisions
Featured Speakers
Isabel Guerrero
Isabel Guerrero Montero is a Senior CMC Scientist at Viralgen, where she supports AAV gene therapy manufacturing programs through upstream process expertise and CMC execution. Her work focuses on translating process and platform knowledge into practical strategies that help advance programs toward commercial readiness, including technology transfer, process understanding and risk-based manufacturing preparation. Isabel brings a strong technical perspective to discussions on how structured CMC data, fit-for-purpose MSAT strategy and platform-informed decision-making can help de-risk the path from clinical development to patients.
Partner for this event
Viralgen
Viralgen is a leading CDMO specializing exclusively in AAV-based gene therapies, offering end-to-end support from early development to commercial production. Using our proprietary Aava™ suspension platform, we achieve scalable manufacturing across all AAV serotypes. With cGMP-certified facilities in San Sebastián, Spain, featuring bioreactors up to 2,000L, we provide integrated services including plasmid production, process optimization, fill-finish, and in-house QC testing. Our approach accelerates development timelines while controlling cost-of-goods. With over 2,000 AAV batches produced and a strong regulatory track record, Viralgen delivers reliable, efficient solutions that help bring gene therapies to patients with greater speed and consistency.