CARsgen Therapeutics (CArsgen) announced the opening of CAR-T cell manufacturing facility in Shanghai to support CARsgen clinical programs. It is China’s first CAR-T cell manufacturing platform that is in strict compliance with current good manufacturing procedure (cGMP) regulations of China FDA.
CARsgen President and CEO, Dr. Zonghai Li said that this facility marks a significant milestone of CARsgen as it embedded their leading expertise and insights into CAR-T cell manufacturing. They have already developed a strong CAR-T portfolio for treatment of many solid tumors including liver cancer, lung cancer, gastric cancer, pancreatic cancer,etc. Next, they plan to submit about 5 Investigational New Drug (IND) applications to CFDA and get at least one IND approval from US FDA by the end of 2018, all requiring a reliable supply of clinical-quality CAR-T cells. So he think this facility will definitely further enhance their clinical research and speed up their IND submission.