Ashley Krull, Ph.D.
Associate Director
W.W. Williams Cellular Therapy Laboratory
The Ohio State University
Columbus, Ohio, USA
The ISCT North America Executive Committee and the Laboratory Practices Committee co-sponsored a webinar on March 12, 2024, entitled “Advances in Point-of-Care Manufacturing: Promise vs. Reality”. Dr. Yossi Schwartz, MD, of Moffitt Cancer Center introduced the co-chairs for the event – Dr. Ashley Krull, PhD, of The Ohio State University and Dr. Elena Maryamchik, MD, of Memorial Sloan Kettering Cancer Center. Dr. Krull introduced the session, describing the vision that she and Dr. Maryamchik had of discussing the coming wave of point-of-care (POC) manufacturing activities and giving labs “metaphorical handholds and footholds” to start climbing the sheer cliff face of implementing POC manufacturing at their own institutions. This topic had been a center point for discussions at both the last ISCT Annual Meeting in Paris, France, and the North America Regional Meeting in Houston, Texas, so the organizers felt strongly that the conversation needed to be presented to a broader audience.
Dr. Maryamchik introduced the first speaker, Dr. Kimberly Schultz, PhD, the Director of the Division of Gene Therapy 2 within the Office of Therapeutic Products at CBER/FDA. Dr. Schultz reprised her highly engaging presentation given in Houston entitled "CBER Perspectives on Point-of-Care Manufacturing”. Her insight as an FDA expert was greatly appreciated by members who attended. She outlined her current thoughts on the opportunities and pitfalls of centralized, decentralized, distributed, and POC manufacturing. Reader, if you did not realize those were all different strategies, we highly suggest listening to the talk. She concluded by describing FDA initiatives to support advanced manufacturing.
The second speaker was Dr. Yongping Wang, MD, PhD, the Director of the Cell and Gene Therapy Laboratory at Children’s Hospital of Philadelphia. Dr. Wang gave a fantastic overview of establishing a POC manufacturing program and didn’t shy away from sharing the challenges that will have to be overcome. He encouraged programs to think critically about the resources currently available and how to justify additional institutional resources.
The last speaker was Dr. Patrick Hanley, PhD, the Chief and Director of the Cellular Therapy Program at Children’s National Hospital. Dr. Hanley was elected VP-North America of the International Society for Cell and Gene Therapy (ISCT) where he also serves on the board of directors. Dr. Hanley shared the challenges and opportunities in POC manufacturing through detailing a real-world example of POC manufacturing of virus-specific T cells (VSTs) through ex vivo expansion with peptides. He highlighted that while the manufacturing is simple and mainly automated, there still exists the limitation that a lack of clear regulatory pathways presents to generating VSTs in-house.
The session ended with a lively question and answer session. Dr. Schultz clarified her definitions of distributed versus decentralized manufacturing, and all the panelists discussed the unmet need for trained personnel at any site wanting to do POC manufacturing. They also touched on the importance of the field keeping in regular conversation with FDA as new regulations are being drafted so they can accurately reflect the best practices of cell and gene therapy manufacturing in all its forms.
The organizers hoped this seminar would educate and inspire ISCT members to keep pursuing point-of-care manufacturing activities, knowing there are resources and experienced members within ISCT to reference and call on for help.
Access the webinar on demand: https://lms.isctglobal.org/products/member-exclusive-2024-webinar-advances-in-point-of-care-manufacturing-promise-vs-reality#tab-product_tab_overview