November 17, 2017 saw the opening of the Advanced Cell Therapy Shanghai Summit 2017 (ACTSS2017), which was held at Grand Hyatt Shanghai. The event was attended by more than 50 CAR-T experts from around the world, including European and American drug regulators, key opinion leaders, drug industry entrepreneurs, investors and patent lawyers. Philip Coelho, chief technology officer of ThermoGenesis Corp., a U.S. subsidiary of Boyalife Group, delivered a presentation regarding the next generation of automated, closed CAR-T biomanufacturing systems, known as CAR-TXpress™. Hairong Xiao, assistant president of Boyalife Group, also attended the summit.
The significant advancements made in CAR-T therapy during 2017 were the main focus of the Summit. In July 2017, the FDA Oncologic Drug Advisory Committee approved Novartis’ CTL-019 (now known commercially as KYMRIAH™) by a vote of 10:0, which officially ushered in the CAR-T cell therapy era. A second CAR-T product by Gilead/Kite (now known commercially as Yescarta™) was approved shortly thereafter. However it quickly became evident that these cutting edge therapies need to adhere to strict quality control specifications. Additionally, expanding production scale and reducing costs also represent significant industry obstacles.
In his presentation, “Next Generation of Automated Closed CAR-T Biomanufacturing Systems,” Dr. Coelho introduced ThermoGenesis’ closed and automated production system for the design and development of cell therapy products, CAR-TXpress™, and explained its proprietary process. The fully-automated CAR-T production line, consisting of eight sets of automated equipment, will enter into formal development and production in Tianjin at the end of 2018, and could set a new global standard for low-cost biomanufacturing systems. The CMC production line is able to improve cell production efficiency and recycling rates while reducing production times by 75%. Car-TXpress also improves the production efficiency of T-cells, enabling scaled and automated cell manufacturing.
The successful Summit meeting enabled all participants to see the latest in cutting-edge CAR-T manufacturing technology, which helps foster ideas for additional research and development. This unique gathering of experts from a variety of disciplines should serve to accelerate development of China’s CAR-T industry. ThermoGenesis’ first, fully-automated, closed CAR-T cell CMC production line represents a significant advancement in cell manufacturing, and is consistent with the “Made in China 2025” national strategy to comprehensively upgrade Chinese industry.
Philip Coelho, chief technology officer of ThermoGenesis (a Boyalife Company)