Introduction:
Shanghai-based CARsgen Therapeutics (Carsgen) announced the opening of CAR-T cell manufacturing facility in Shanghai to support CARsgen clinical programs.
Features:
CAR-T cell manufacturing facility is in strict compliance with current good manufacturing procedure (cGMP) regulations of China Food and Drug Administration (CFDA).
The 33, 000-square-foot facility features state-of-art capabilities to manufacture vectors and CAR-T cells to support CARsgen clinical programs.
This facility marks a significant milestone of CARsgen as it has embedded the leading expertise and insights into CAR-T cell manufacturing.
CARsgen Therapeutics (CARsgen) has developed a strong CAR-T portfolio for treatment of many solid tumors including liver cancer, lung cancer, gastric cancer, pancreatic cancer and so on.
CARsgen is planning 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.
Specifications:
| Name | CARsgen Therapeutics (CARsgen) |
| Location | Shanghai, China |
| Type | New Manufacturing Facility |
| Parties Involved | CARsgen Therapeutics |
