World class CMC team at CARsgen are devoted to manufacturing advanced CAR T-cell products using cutting-edge automation technologies and superior process solutions. The company has technical know-how and owns manufacturing patents in producing CAR T-cell products for patients having solid tumor or blood cancer. Highly experienced CMC leaders direct the fully integrated CMC operations and implement the quality management system for drug production, testing, release, logistics. Point-of-care manufacturing process developed by CARsgen team ensures fast delivery of CAR T-cell products to meet urgent medical needs.
The company has launched two state-of-the-art manufacturing facilities in Shanghai, China. CARsgen is the first cell therapy company that received Drug Production License from CDE/NMPA for producing CAR T-cell products in China. CARsgen has opened its current Good Manufacturing Practices (CGMP) manufacturing facility located at the Research Triangle Park (RTP) in North Carolina. U.S.
The sustainable and scalable production at CARsgen will provide strong support to worldwide clinical trials and commercialization in coming years.