Development of Automated Systems for Cell Therapy

The introduction of automated systems that can increase manufacturing efficiency and eliminate human errors is indispensable for the dissemination of cell therapy. However, a robotic operation without process monitoring and manufacturing records needs a "verification" process at the end of manufacturing for each shipment, just like manual operation would have required, which is called the Pharma 3.0 manufacturing stage, and would not visualize the manufacturing process nor link with inventory control. A simple robotic system that can mimic human operation will not contribute to innovation in the cell manufacturing industry. Here we show the quality by design (QbD)-based automated closed-type cell manufacturing system with in-process monitoring that could eliminate a "verification" process prior to shipment and assure the quality of the product by manufacturing the product as designed, which will contribute to the industrialization of cell manufacturing that can support the dissemination of cell therapy.