PERSPECTIVE article
Front. Bioeng. Biotechnol.
Sec. Cell and Gene Therapy
Volume 13 - 2025 | doi: 10.3389/fbioe.2025.1612248
Industrializing CAR-T cell Therapy: Impact of automation on cost and space efficiency of manufacturing facilities
Provisionally accepted
Anna Louisa Weltin1,2,3,4,5*
Ysanne De Graaf3
Amir Goudarzi2
Mirko Müller5
Laura Herbst1
Bastian Nießing1
Robert Schmitt4- 1Fraunhofer Institute for Production Technology (FHG), Aachen, Germany
- 2Bayer (Germany), Wuppertal, North Rhine-Westphalia, Germany
- 3Maastricht University, Maastricht, Netherlands
- 4Laboratory for Machine Tools and Production Engineering, RWTH Aachen University, Aachen, Germany
- 5Fraunhofer Institute for Cell Therapy and Immunology (IZI), Leipzig, Lower Saxony, Germany
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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.
Keywords: Humans Receptors, Chimeric antigen, T-Lymphocytes, Leukemia, Technology, Automation
Received: 15 Apr 2025; Accepted: 22 Sep 2025.
Copyright: © 2025 Weltin, De Graaf, Goudarzi, Müller, Herbst, Nießing and Schmitt. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Anna Louisa Weltin, louisa.weltin@ipt.fraunhofer.de
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.