Supplementary file 1_Industrializing CAR-T cell therapy: impact of automation on cost and space efficiency of manufacturing facilities.docx

The A-Cell Case Study published by the “Alliance of Regenerative Medicine” illustrates how Quality-by Design can be applied to the manufacturing of Advanced Therapeutical Medicinal Products (ATMPs), using Chimeric Antigen Receptor (CAR)-T cell therapy as a ‘model’ process. However, no emphasis is given to different degrees of automation in this study. CAR-T cell therapies have been developed for various forms of leukemia, such as Acute Lymphoblastic Leukemia (ALL) or Non Hodgkin-Lymphoma (NHL). As more CAR-T cell therapies reach market approval and are being considered as first- or second line treatments, the economic efficiency and scalability of the chosen production modality become increasingly critical. Currently, academic and industrial manufacturers employ a range of approaches, from fully manual and open processing to closed and automated systems. New technologies, investments and cleanroom space requirements must be considered to assess economic and spatial efficiency in cell therapy manufacturing. This study analyses the costs and space requirements of different production modalities for autologous CAR-T cell production. The analysis shows that a higher degree of automation can reduce manufacturing costs by lowering personnel costs, cleanroom grade requirements and spatial footprint. It emphasizes the importance of maximizing cleanroom efficiency to support the scalable production of cell therapies as clinical demand grows. These results underscore the need for both industry and academia to consider automated production as a strategic approach to optimize resource use in CAR-T cell manufacturing.