Development of a new semi-automated closed modular system for CAR-T cell therapy manufacturing

• Published in: Cytotherapy (Oxford, England) England), 2020-05, Vol.22 (5), p.S201-S201
• Main Authors: Weist, M., Gordon, M., Hedley, E., Liang, T. Soh Woon, Rossman, S., Odelson, D., de Mollerat du Jeu, X.
• Format: Article
• Language: English
• ISSN: 1465-3249; 1477-2566
• DOI: 10.1016/j.jcyt.2020.04.075

CAR T-cell therapy is a transformative cancer treatment that utilizes genetically modified cells from a patient's own immune system to attack cancer cells. Manufacturing of these cells represents a major challenge for the industry. Today, the manufacturing process lacks specific cell therapy equipment, is labor intensive, and has many “open” (vs closed) procedures. Herein we discuss the development of a new semi-automated closed modular system for CAR-T cell therapy manufacturing. The system integrates existing and newly developed platforms (modules). Specifically, we incorporated and controlled these modules via TrueBio software and the DeltaV Control system. In addition to automating the process, the DeltaV system provides a 21 CFR Part 11 compliant control platform . The DeltaV PK Controller is ideal for the smaller scale process and can be operated in stand-alone mode or as part of a larger system. The associated Syncade MES and Electronic Batch Records will allow material tracking as well as electronic workflows and data collection. Our goal is to engineer a small footprint, closed, semi-automated system to improve process reliability, robustness and flexibility while at the same time affording a significant reduction in cell manufacturing cost. The modularity of the system provides process flexibility and allows the processing of multiple samples in parallel since the operation of individual modules does not block the use of other modules within the train. As processing needs change, the cell manufacturing train can be adapted by selecting the appropriate modules for the task in hand. We believe that this semi-automated process will help alleviate the challenges that the cell therapy manufacturing represents today and ultimately reduce the cost of these live-saving therapies so they can be accessible to a larger group of patients.