Head of R&D
Personalized Medicine
Lonza
Head of Regulatory Affairs, Personalized Medicine, Lonza
Head of Laboratory
Ella Lemelbaum Institute of Immuno-Oncology
Sheba Medical Center
Broadcast Date: October 27, 2021
Time: 8:00 am PT, 11:00 am ET, 1600 CET
Establishing comparability in manufacturing cell therapies is a significant challenge for the field due to the complexity of the products, limited material availability, and inherent donor-to-donor variability. As products progress through their lifecycles, organizations need to focus on their ultimate manufacturing end goal. In addition, commercialization and application of cell therapy products to larger patient populations drive the need to switch from small-scale, manual, or semi-automated single function-based production models to more robust and efficient commercial-scale manufacturing using closed and automated end-to-end platforms.
In this GEN webinar, our expert panelists will share insights on establishing a robust, automated cell manufacturing process that meets clinical and commercial demands while successfully navigating the ever-changing regulatory landscape for establishing comparability in a clinical product. Additionally, we will learn about a new automated and flexible solution—Cocoon®—which enables scale-out capable of meeting commercial demands and how it can provide solutions for transitioning manual CAR-T production to automated processes.
A live Q&A session will follow the presentation, offering you a chance to pose questions to our expert panelist.
Produced with support from:
The post Cell Therapy Manufacturing and Clinical Comparability: What, How, and When appeared first on GEN – Genetic Engineering and Biotechnology News.
