CAR T-cell therapies specialist CARsgen Therapeutics (Shanghai) has announced the completion of a 37,000-ft2 facility for clinical and early-stage commercial manufacturing after 12 months of construction.
The company enlisted the help of CRB (St. Louis) in building the cGMP manufacturing facility located within the Research Triangle Park In Durham, North Carolina. CRB is an engineering, architecture construction firm.
The site has the capacity to produce autologous CAR T-cell products for 700 patients each year.
The site has passed U.S. government inspections.
The cleanrooms at the Durham site use a modular construction system.
“Our new state-of-the-art facility expands our global cGMP manufacturing capacity and capability to produce innovative CAR T-cell products for patients in North America and Europe,” said Jie Jia, said vice president, strategic alliances and operations of CARsgen, in a news release.
The new site will support Phase 2 CT053 and Phase 1 CT041 clinical trials.
CT053 is an autologous CAR T-cell product candidate against B-cell maturation antigen, while CT041 is a claudin18.2-targeted CAR T-cell therapy.
Filed Under: Drug Discovery, Drug Discovery and Development