{"id":47934,"date":"2022-09-02T15:01:55","date_gmt":"2022-09-02T13:01:55","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/carsgen-releases-the-first-clinical-batch-of-car-t-cells-from-its-rtp-gmp-manufacturing-facility-in-north-carolina\/"},"modified":"2022-09-02T15:01:55","modified_gmt":"2022-09-02T13:01:55","slug":"carsgen-releases-the-first-clinical-batch-of-car-t-cells-from-its-rtp-gmp-manufacturing-facility-in-north-carolina","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/carsgen-releases-the-first-clinical-batch-of-car-t-cells-from-its-rtp-gmp-manufacturing-facility-in-north-carolina\/","title":{"rendered":"CARsgen Releases the First Clinical Batch of CAR T Cells from its RTP GMP Manufacturing Facility in North Carolina"},"content":{"rendered":"
\n

SHANGHAI–(BUSINESS WIRE)–CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announces that the company\u2019s Current Good Manufacturing Practice (CGMP) manufacturing facility<\/b> located at the Research Triangle Park (RTP) in North Carolina, the United States of America (\u201cThe RTP GMP Manufacturing Facility\u201d) has started GMP production of autologous CAR T-cell products and successfully released the first GMP batch for the clinical trials<\/b>.\n<\/p>\n

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\nThe RTP GMP 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 to support clinical studies and early commercial launch in North America and Europe. \u201cI am very pleased to announce that the RTP Manufacturing Facility has achieved the company\u2019s target of releasing the clinical batches for the U.S. patient use in Q3, 2022,\u201d said Mr. Richard Daly, President of CARsgen Therapeutics Corporation. \u201cCARsgen is rapidly expanding the in-house capacity of manufacturing and quality testing in the United States. The company will accelerate the ongoing clinical studies by providing more promising CAR T-cell products to the global patients.\u201d\n<\/p>\n

\n\u201cThe successful release of the first U.S. patient product at the RTP GMP Manufacturing Facility is a remarkable milestone for CARsgen and our trusted partners,\u201d added by Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics Holdings Limited. \u201cBy taking the advantage of the vertically integrated production at CARsgen, our world-class 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.\u201d\n<\/p>\n

\nApart from several ongoing clinical studies in China, the company has two active INDs, including a Phase 2 pivotal study of CT053 for relapsed\/refractory multiple myeloma and a Phase 1b study of CT041 for advanced gastric and pancreatic cancers, both cleared by the U.S. FDA and the Health Canada. In fact, CARsgen is the only CAR T company to have received RMAT and PRIME designations for both heme (CT053) and solid (CT041) tumor therapies.\n<\/p>\n

\nAbout CARsgen Therapeutics Holdings Limited<\/b>\n<\/p>\n

\nCARsgen is a biopharmaceutical company with operations in China and the U.S. and is 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 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. The Company\u2019s vision is to become a global biopharmaceutical leader that brings innovative and differentiated cell therapies to cancer patients worldwide and makes cancer curable.\n<\/p>\n

Contacts<\/b> <\/p>\n

\nFor more information, please visit https:\/\/www.carsgen.com\/<\/a>
Contact CARsgen PR: pr@carsgen.com<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

SHANGHAI–(BUSINESS WIRE)–CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announces that the company\u2019s Current Good Manufacturing Practice (CGMP) manufacturing facility located at the Research Triangle Park (RTP) in North Carolina, the United States of America (\u201cThe RTP GMP Manufacturing … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-47934","6":"format-standard","7":"category-industry"},"yoast_head":"\nCARsgen Releases the First Clinical Batch of CAR T Cells from its RTP GMP Manufacturing Facility in North Carolina - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/carsgen-releases-the-first-clinical-batch-of-car-t-cells-from-its-rtp-gmp-manufacturing-facility-in-north-carolina\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"CARsgen Releases the First Clinical Batch of CAR T Cells from its RTP GMP Manufacturing Facility in North Carolina - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"SHANGHAI–(BUSINESS WIRE)–CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announces that the company\u2019s Current Good Manufacturing Practice (CGMP) manufacturing facility located at the Research Triangle Park (RTP) in North Carolina, the United States of America (\u201cThe RTP GMP Manufacturing ... 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