Cellares, University of Wisconsin expand CAR-T manufacturing partnership

California-based Cellares, an integrated development and manufacturing organization for cell therapies, and the University of Wisconsin School of Medicine and Public Health announced an expanded partnership to support clinical manufacturing and regulatory advancement of a CRISPR-edited GD2 CAR-T investigational therapy.

The collaboration builds on an initial agreement announced in April 2025 that focused on automating the university’s internally developed CAR-T process. Following performance and reliability results from the automated manufacturing approach, the university selected Cellares to support the program’s transition to clinical manufacturing.

Under the expanded agreement, Cellares will provide manufacturing support using its automated Cell Shuttle platform and Cell Q automated quality control system. The company will also provide regulatory expertise for preparation of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration, including contributions to the Chemistry, Manufacturing and Controls section, while the university retains ownership and leadership of the IND filing, the organizations said.

The GD2 CAR-T program targets solid tumors in pediatric and adult patients, initially focusing on high-grade gliomas, with potential future studies in neuroblastoma, osteosarcoma and melanoma. The program uses CRISPR gene editing to modify patient T cells via electroporation, an approach that requires consistent, reproducible manufacturing to meet batch specifications, according to the announcement.

Earlier this month, Cellares also announced a collaboration with Stanford University School of Medicine to automate manufacturing and release testing for gene-edited hematopoietic stem cell therapies.