Minerva Knowledge and Risk Management转发了
I recently revisited an insightful video by Carol Houts of Germfree, recorded at the Meeting on the Mesa by the Alliance for Regenerative Medicine (Oct. 7–9, 2024) titled "Advancing Patient Access through Decentralized Manufacturing". In it, she makes a compelling case for increasing therapy accessibility, reducing costs, and streamlining regulatory frameworks to bring advanced therapies to more patients. Carol has a novel way of explaining the expansion of current centralized manufacturing toward the end goal of point-of-care (POC) manufacturing. This is a topic I am passionate about. I believe the future of advanced therapy manufacturing will be a blend of centralized, decentralized, and POC on-demand production models. The continuous improvement of each of these models is necessary to satisfy present and future demand: ?? Centralized hubs: Essential for large-scale, high-volume manufacturing. ?? Decentralized sites: Distributed manufacturing closer to the POC but not at the hospital. ?? Point of Care: Manufacturing at the hospital, on demand. One of my goals is transforming advanced therapy manufacturing into a procedure. With advances in visual intelligence, automation, robotics, and AI-driven QC, we can turn therapy manufacturing into something as common as a dialysis procedure, making it available in diverse settings—such as specialty pharmacies, apheresis centers, specialized clinical laboratories, and even medical offices. This is a future I am excited about. I know that together we can push the boundaries to ensure all manufacturing options are available to meet present and future demand. This is a great time for collaboration and innovation! #AdvancedTherapies #CellTherapy #GeneTherapy #Biomanufacturing #DecentralizedManufacturing #PointOfCare #RegenerativeMedicine #ManufacturingInnovation