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Co-Chair: Dr. Lindong Weng - Sana Biotechnology, USA
Co-Chair: Dr. Peter Kilbride - Cytiva, UK
 PRACTICAL CRYOPRESERVATION CONSIDERATIONS OF AUTOLOGOUS AND ALLOGENEIC CELL THERAPY
Dr. Chia-Hsing Pi Senior Scientist, Process Development Engineering, Vertex Pharmaceuticals, USA
Since the first autologous CAR-T approved in 2017 and first allogeneic T-cell immunology approved in 2022, people start to pay more attentions on cryopreservation of cells. Suboptimal cryopreservation can lead not only to batch-to-batch variation, lowered cellular functionality and reduced cell yield. This requires attention to all aspects of the application of low temperatures: from the choice of freezing container and cryoprotectant, the cooling rate and its mode of delivery, the handling during storage and transportation, to the product thawing by the end-user. The speaker will share his experience and considerations with fit-for-purpose approaches for allogeneic and autologous cell therapies.
Bio: Chia-Hsing Pi, Ph.D., currently works at Vertex Pharmaceuticals as a senior scientist in process development engineering. Before joining Vertex, he worked in BlueRock Therapeutics for iPSC-derived cell therapy, where he supervised the cryopreservation process for all cell types including cardiology, neurology and immunology. He received his Ph.D in Allison Hubel, Ph.D.’s lab from University of Minnesota. In Graduate School, he used computational tools to understand interactions between osmolytes and optimize the preservation of heterogeneous populations of primary cells.
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 ADDRESSING THE CHALLENGES OF CRYOGENIC STORAGE FOR CELL THERAPIES
Dr. Sean Werner CTO Cell Processing, Sexton Biotechnologies, USA
Cryogenic storage of high value, sensitive biologic materials such as cell therapies requires unique container attributes to mee the stringent quality and performance requirements for a drug product. The CellSeal vial was the first cryogenic storage container developed explicitly for the cell and gene therapy industry. Over the last ten years, new variants of vials and bags have arrived on the market. This presentation will provide an overview of the development the CellSeal vial, the current state of the industry, and remaining needs.
Bio: Sean Werner is the Chief Technology Officer – Cell Processing at BioLife Solutions. Previously, Sean was President of Sexton Biotechnologies, providing processing and handling solutions for the CGT industry including the CellSeal cryogenic vial and associated handling tools. Sean has previous experience filling various roles in the global regulatory and general management functions supporting medical devices, autologous cell therapy, and single use disposable development programs.
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