Industrializing CAR-T cell therapy: impact of automation on cost and space efficiency of manufacturing facilities.

ABSTRACT: 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

SUBMITTER: Weltin AL 

PROVIDER: S-EPMC12816348 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature