Join Christian Estes and Michael Lennon as they present on Car-T Facility Design - Autologous vs. Allogeneic as part of the concurrent session on ATMP - New Modality Processing Approaches at the ISPE Annual Meeting.
Chimeric antigen receptor T cell (CAR-T) therapy clinical and commercial-scale manufacturing has exploded as its own sector within the Cell and Gene industry. Emerging manufacturers are looking for the limits on their ability to plan for scaling their production. Many are now understanding the specific facility requirements for producing both Autologous and Allogeneic products and what scaling methods can be applied, whether it be scaling up, scaling out, or a combination of both, Scaling Squared (S2). We will compare these two facilities types, which have similarities and differences that are important to understand in order to determine how production can be scaled. We will describe the difference between Autologous and Allogeneic CAR-T product requirements, examples of clinical and commercial-scale manufacturing facilities, and highlight their specific differences. These requirements directly drive initial capital investments for young or transitioning manufacturing companies, and therefore become a hurdle toward getting from R&D to Clinical/Commercialization. Participants will better understand: How Autologous and Allogeneic Car-T products are manufactured. See examples of each facility type highlighting their differences and how to expand each. Better understand what it takes to move from one product type to another, even in a single facility (multi-product).
Find out more information and register here.