CARsgen Therapeutics, a company mainly focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, recently opened its new 37,000 square foot clinical and early-stage commercial manufacturing facility. This is the first manufacturing facility in North America for the Shanghai-based corporation.

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

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.

“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, vice president, strategic alliances and operations, CARsgen Therapeutics. “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.”

Zonghai Li, CEO, CARsgen, said, “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.”