As AAV-based gene therapy programs move from late-stage clinical development toward commercialization, CMC execution is a key factor in determining launch readiness. For rare disease programs —where timelines, material availability and patient need are especially constrained—avoiding late-stage CMC surprises is particularly important.
In this webinar, Isabel Guerrero, Senior CMC Scientist at Viralgen, shows how AAV teams can turn process characterization data into defensible operating ranges and set-points, and walks through the decision-making framework behind those calls using a real-world AAV program example.
View the webinar to learn how platform knowledge, process characterization and PPQ planning can help improve regulatory interactions, and accelerate and de-risk AAV therapy commercialization.
