CAR T-cell therapy product manufacturing facility
CARsgen Therapeutics, a Shanghai-based corporation focused on treating hematologic malignancies and solid tumors with CAR T-cell therapies, wanted to expand their global cGMP manufacturing capacity to North America and Europe. They selected CRB in 2020 to provide site selection support for a clinical and early-stage commercial manufacturing facility and ultimately settled on North Carolina’s Research Triangle Park.
Transformation from warehouse and office to manufacturing
CRB continued as CARsgen’s partner for the life of the project, providing professional engineering, design, and construction services for the adaptive reuse of what had been an office and warehouse built in the early 1990s. Using an integrated project delivery approach, it took just 12 months to transform the building into CARsgen’s new 37,000-square-foot CAR T-cell therapy facility.
The adaptation of an existing light duty structure originally designed for office use posed unique challenges when converting to accommodate the equipment required for advanced technology suites. Our team developed novel solutions to maximize available vertical space and to reengineer the existing structure to create functional space with minimal modification to the building shell.
One key solution was the incorporation of a modular cleanroom system that allowed for schedule advancement while meeting the requirements of a controlled environment. In conjunction with our trade partners, we were able to defer a substantial portion of the mechanical, electrical, and process trunk lines to offsite fabrication, which allowed for enhanced safety and quality. The aggregated effort of these solutions and many others yielded a project that was on schedule and under budget.
Integrated CAR T-cell therapy platform
CARsgen has established a comprehensive CAR T-cell research and development platform, encompassing target discovery, innovative CAR T-cell development, clinical trials, and commercial-scale production. Highlighted in their pipeline are CT053 (or “Zevor-cel”), a BCMA-targeted CAR T-cell therapy for relapsed/refractory multiple myeloma, and CT041, a Claudin18.2-targeted CAR T-cell therapy for advanced gastric and pancreatic cancers.
The new facility provides increased manufacturing capacity of these CAR T-cell therapies for 700 patients annually.
Research Triangle Park, NC