Research Fellow Fraunhofer-Institute for Production Technology, Germany
Abstract: Autologous Chimeric Antigen Receptor (CAR) T cell therapy is one of the most advanced immunotherapies to date. Since the approval of the first CAR-T cell therapy by the FDA in 2017, many technological advancements have been made in the design of CARs, mode of genetic engineering of T cells and composition of the CAR T cell product. How-ever, manufacturing of CAR-T cells remains mainly manual or semi-automated with little insight into the bioprocess and static process control. New manufacturing approaches are needed to lower costs to improve manufacturing capacity and shorten provision times. Semi-automated devices such as the Miltenyi Prodigy® were developed to reduce hands-on production time. However, these devices are not equipped with the process analytical technology necessary to fully characterize and control the process. An auto-mated AI-driven CAR-T cell manufacturing platform in smart manufacturing hospitals (SMH) is being developed to address these challenges. Automation will increase the cost-effectiveness and robustness of manufacturing. The smart integration of automated CAR-T cell manufacturing platforms into hospitals enables the independent manufacture of autologous CAR-T cell products. It leads to a paradigm shift from centralized ATMP production towards point-of-care treatment. This talk will elaborate on the translation of manual CAR-T cell manufacturing and quality control to an automated system with a focus on adaptability to the changing needs of the industry.