Cellares, University of Wisconsin team on clinical-scale production of CAR-T therapy
San Francisco-based Cellares announced that it has teamed with the University of Wisconsin School of Medicine and Public Health to automate the manufacturing of a CRISPR-edited GD2 CAR-T investigational therapy for solid tumors.
The partners will leverage Cellares’ Cell Shuttle technology to simultaneously manufacture multiple cell therapy products in parallel to overcome traditional manufacturing bottlenecks and accelerate development towards clinical trials.
“By collaborating with researchers at the University of Wisconsin-Madison on their CRISPR-edited GD2 CAR-T product, we remove the manufacturing barriers that can hinder promising research,” Fabian Gerlinghaus, co-founder and CEO of Cellares, said in a statement.
Cellares’ Cell Shuttle automates and scales production to a clinical level, “which accelerates the transition from academic innovation to investigational therapy and brings hope to those who need new treatment options,” according to Gerlinghaus.
Earlier this month, Cellares announced that its Cell Shuttle was granted the Advanced Manufacturing Technology (AMT) designation by the FDA’s Center for Biologics Evaluation and Research.
Cellares said that the AMT designation gives its customers using the Cell Shuttle priority review from the FDA, leading to accelerated regulatory filings and resulting in decreased times to Investigational New Drug (IND) and Biologic License Application (BLA).
Last month, Cellares announced that it successfully completed a Technology Adoption Program (TAP) using its Cell Shuttle for Cabaletta Bio’s lead clinical candidate rese-cel, a CAR T-cell therapy designed to treat patients with a broad range of autoimmune diseases.
Cellares is deploying its Cell Shuttle at the company’s integrated development and manufacturing organization (IDMO) “smart” factories. The first commercial scale smart factory is operational in Bridgewater, New Jersey, with other facilities under construction in Europe and Japan.