CARsgen Therapeutics launches 37,000-ft cleanroom facility for clinical and early-stage commercial manufacturing


CARsgen Therapeutics 37,000-ft2 facility for clinical and early-stage commercial manufacturing was designed and built in just 12 months.

CARsgen Therapeutics, a company mainly focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announced today the grand opening of the newly completed 37,000-ft2 clinical and early-stage commercial manufacturing facility. This is the first manufacturing facility in North America for the Shanghai-based corporation.

CRB, an international leader in sustainable engineering, architecture, construction, and consulting solutions to the life sciences industry, spearheaded the design and construction of the cell & gene therapy space using its ONEsolution™ approach to deliver the project and meet aggressive goals on schedule and budget.

Jie Jia, PhD, Vice President, Strategic Alliances and Operations, CARsgen Therapeutics and Ryan Lowden, Project Director, CRB provided a tour of the new facility for guests, including North Carolina state and local government and economic development officials and business partners, at the grand opening celebration on Friday morning.

The cleanroom spaces in the new facility were built with a unique modular construction system that allowed for an enhanced schedule while meeting the requirements of a controlled environment.

“It has been a privilege to work with CARsgen Therapeutics to deliver this project in support of innovative and differentiated cell therapies for cancer patients. Using our ONEsolution delivery method enabled us to fast-track and complete the project in just 12 months,” said Ryan Lowden.

“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, Ph.D. “The facility was designed and built to facilitate the transformation from clinical manufacturing to commercial production so that we can secure drug supply chain and support FDA-cleared Phase 2 CT053 and Phase 1 CT041 clinical studies,” Jia added.

“We’re all pleased to celebrate the completion of CARsgen’s new manufacturing facility, which is an instrumental step in our global strategy. The RTP manufacturing facility will provide additional production capacity for autologous CAR T-cell products and will support our clinical studies and early commercial launch in North America and Europe. Most of all, it will help CARsgen deliver an effective treatment with substantial survival benefit to the patients around the world,” said Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics Holdings Limited.

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About CARsgen Therapeutics

About CARsgen Therapeutics

CARsgen is a biopharmaceutical company with operations in China and the U.S. mainly 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. CT053 is a BCMA-targeted CAR T-cell therapy for treating relapsed/refractory multiple myeloma. CT041 is a Claudin18.2-targeted CAR T-cell therapy to treat advanced gastric and pancreatic cancers.

About CRB
About CRB: CRB is a leading provider of sustainable engineering, architecture, construction, and consulting solutions to the food and beverage and life sciences industries. Led by its innovative ONEsolution™ service, CRB provides successful integrated project delivery for clients demanding high-quality solutions, on time and within budget. The company’s more than 1,600 employees provide world-class solutions that drive success and positive change for their clients, people, and communities. CRB is a privately held company with a rich history of serving clients throughout the world, consistently striving for the highest standard of technical knowledge, creativity, and execution.

SOURCE: CARsgen Therapeutics