For cell and gene remedy applications, early growth choices can have a big influence on regulatory success, growth timelines, and total program threat. Embedding regulatory technique from the outset helps builders establish crucial challenges early, align growth actions with product-specific necessities, and construct a stronger basis for future medical and business milestones.
On this GEN webinar, specialists from Rose BioSolutions, a CDMO and Cell Options group shaped from Charles River Laboratories’ companies, will talk about how integrating regulatory technique on the earliest levels of growth can cut back total threat and enhance program outcomes. Attendees will learn the way a well-defined Goal Product Profile (TPP) can information decision-making throughout the drug growth lifecycle, and assist groups prioritize actions, anticipate regulatory expectations, and develop a fit-for-purpose CGT manufacturing and testing technique. Presenters will use real-world case research to spotlight frequent cell and gene remedy product growth challenges and sensible approaches to addressing points equivalent to sterility testing, interim product launch, and gadget compatibility at affected person infusion.
Key Takeaways
The best way to implement a regulatory technique throughout program scoping to align growth actions with product-specific dangers and compliance expectationsWhy a Goal Product Profile (TPP) ought to be established at first of growth and the way it guides technique, crucial high quality necessities, and threat mitigation plansHow early identification of product-specific challenges can assist decrease pointless regulatory info requests, keep away from manufacturing delays, and help well timed affected person treatmentPractical methods for creating a extra environment friendly, inspection-ready path from early growth by way of medical manufacturing and commercialization
A dwell Q&A session will observe the presentation providing you an opportunity to pose inquiries to our skilled panelists.
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