CARsgen Therapeutics has announced the start of production at its Current Good Manufacturing Practice (CGMP) manufacturing facility in North Carolina, US and released the first CAR T cells batch for clinical trials.
Located at the Research Triangle Park (RTP), the facility has nearly 3,300m2 of total gross floor area and will provide additional manufacturing capacity to produce autologous CAR T-cell products for 700 patients per year.
This will support the clinical trials as well as the early commercial launch of the CAR T-cell products in North America and Europe.
CARsgen Therapeutics founder, board chairman, CEO, and chief scientific officer Dr Zonghai Li said: “The successful release of the first US patient product at the RTP GMP Manufacturing Facility is a remarkable milestone for CARsgen and our trusted partners.
“By taking the advantage of the vertically integrated production at CARsgen, our CMC team could complete the global technology transfer from our China manufacturing facility and then advance to the clinical manufacturing effectively.
“The commencement of clinical production at the RTP GMP Manufacturing Facility will greatly reduce current risks of global supply chain shortage and strengthen the value chain of CARsgen.”
The company has two active INDs, including a Phase II pivotal trial of CT053 to treat relapsed/refractory multiple myeloma and a Phase Ib study of CT041 for the treatment of advanced gastric and pancreatic cancers.
Both the studies have already received approvals from the Health Canada and the US Food and Drug Administration (FDA).
CARsgen is claimed to be the only CAR T company which has received RMAT and PRIME designations for heme (CT053) and solid (CT041) tumour therapies.