CARsgen Therapeutics Holdings Limited, a company focused on innovative CAR T-cell therapies announced that its current Good Manufacturing Practices (cGMP) manufacturing facility located at the Research Triangle Park (RTP) in North Carolina, the United States of America (“The RTP Manufacturing Facility”) has successfully passed the official inspections by local government. CARsgen has received the Certificate of Compliance from the City-County Inspections Department of Durham, enabling CARsgen to advance to clinical manufacturing.
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The commencement of operations at the state-of-the-art RTP Manufacturing Facility, with a total gross floor area of approximately 3,300 sq.m, will provide CARsgen additional manufacturing capacity of autologous CAR T-cell products for 700 patients annually. The RTP Manufacturing Facility will support the company’s clinical studies and early commercial launch in North America and Europe. CARsgen is building a world-class CMC team for the RTP manufacturing facility operations. The RTP Manufacturing Facility project adopted an integrated project delivery approach that greatly shortens construction turnaround time and improves cost effectiveness. This project received the Job Development Investment Grant (JDIG) award and other investment incentives from North Carolina state, Durham County and Durham City.
“We’re all pleased to celebrate grand opening of CARsgen’s first U.S. cGMP manufacturing facility, which is an instrumental step in our global strategy. RTP manufacturing facility plus two CARsgen existing GMP facilities in Shanghai, China will enhance our global manufacturing capacity, strengthen supply chain sustainability, advance our clinical studies, and position CARsgen for early commercial launch. Most of all, it will help CARsgen deliver an effective treatment with substantial survival benefit to the patients around the world,” said Mr. Richard John Daly, President of CARsgen Therapeutics Corporation (a subsidiary of CARsgen Therapeutics Holdings Limited in the United States).
CARsgen is a biopharmaceutical company with operations in China and the U.S. focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors. The company has built an integrated cell therapy platform with in-house capabilities that span target discovery, antibody development, clinical trials, and commercial-scale manufacturing. CARsgen’s has internally developed novel technologies and a product pipeline with global rights to address major challenges of CAR T-cell therapies, such as improving the safety profile, enhancing the efficacy in treating solid tumors, and reducing treatment costs. Our vision is to become a global biopharmaceutical leader that brings innovative and differentiated cell therapies to cancer patients worldwide and makes cancer curable