Toward Rapid, Widely Available Autologous CAR-T Cell Therapy – Artificial Intelligence and Automation Enabling the Smart Manufacturing Hospital

Frontiers in Medicine

article

Simon Hort¹  Laura Herbst¹  Niklas Bäckel¹  Frederik Erkens¹  Bastian Niessing¹  Maik Frye¹  Niels König¹  Ioannis Papantoniou²  Michael Hudecek⁵  John J. L. Jacobs⁶  Robert H. Schmitt¹ 

[1] Fraunhofer Institute for Production Technology IPT;Institute of Chemical Engineering Sciences, Foundation for Research and Technology-Greece;Skeletal Biology and Engineering Research Centre, Department of Development and Regeneration;Prometheus the Leuven R&D Translational Division of Skeletal Tissue Engineering;Lehrstuhl für Zelluläre Immuntherapie, Medizinische Klinik und Poliklinik II, Universitätsklinikum Würzburg;ORTEC BV;Laboratory for Machine Tools and Production Engineering ,(WZL) of RWTH Aachen University

关键词: ATMP;    CAR-T cell;    artificial intelligence;    automation;    autologous;    manufacturing;    Industry 4.0;    smart manufacturing hospital;   

DOI  :  10.3389/fmed.2022.913287

学科分类：社会科学、人文和艺术（综合）

来源: Frontiers

【 摘 要 】

CAR-T cell therapy is a promising treatment for acute leukemia and lymphoma. CAR-T cell therapies take a pioneering role in autologous gene therapy with three EMA-approved products. However, the chance of clinical success remains relatively low as the applicability of CAR-T cell therapy suffers from long, labor-intensive manufacturing and a lack of comprehensive insight into the bioprocess. This leads to high manufacturing costs and limited clinical success, preventing the widespread use of CAR-T cell therapies. 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 automated 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. Using Artificial Intelligence (AI) to interpret the data collected on the platform will provide valuable process insights and drive decisions for process optimization. The smart integration of automated CAR-T cell manufacturing platforms into hospitals enables the independent manufacture of autologous CAR-T cell products. In this perspective, we will be discussing current challenges and opportunities of the patient-specific but highly automated, AI-enabled CAR-T cell manufacturing. A first automation concept will be shown, including a system architecture based on current Industry 4.0 approaches for AI integration.

【 授权许可】

CC BY