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.
Speaker
Isabel Guerrero, Senior CMC Scientist, Viralgen
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.
Message PresenterWho Should Attend?
This webinar will appeal to:
- 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
Attendees will gain insight into:
- 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
Xtalks Partner
Viralgen
Viralgen, an independently operated Contract Development and Manufacturing Organization (CDMO), was founded in 2017 as a joint venture between AskBio and Columbus Venture Partners (a venture capital firm based in Spain). As one of the world’s leading manufacturers of cGMP-certified AAV, Viralgen uses the Pro10™ based suspension manufacturing platform, a technology licensed from AskBio and developed by co-founder R. Jude Samulski, PhD, at University of North Carolina. Pro10™ increases scalability, performance and precision of AAV therapies. Located in Spain, in the Gipuzkoa Science and Technology Park, Viralgen produces AAV gene therapy treatments for pharmaceutical and biotech companies with the aim of accelerating the delivery of new treatments that can improve patients’ lives.
The company’s clinical facilities have four cGMP manufacturing suites, with 250-liter and 500-liter bioreactors. In 2020, Viralgen expanded within the Scientific Park by constructing a new building for increased manufacturing capacity which recently received Current Good Manufacturing Practices (cGMP) certification for the manufacture of human medicinal products, investigational medicinal products, and sterile or biological active substances. This certification was granted following a successful inspection by the Spanish Agency for Medicines and Medical Devices (AEMPS), a part of the European Medicines Agency (EMA) network. The company now operates two facilities in San Sebastian, Spain, with seven state-of-the-art single-use suites that have up to 2,000 liters of manufacturing capacity, making it a world-leading contract development and manufacturing organization (CDMO).
Viralgen has more than 420 employees, with three quarters of these holding advanced degrees. This talented workforce supports a range of core capabilities in quality assurance, quality control, analytical development and process development, all of which are critical to shortening the time to market and supporting customers with the regulatory process.
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