- Cellares and the University of Wisconsin School of Medicine and Public Health have expanded their partnership to support clinical manufacturing and regulatory advancement of a CRISPR-edited GD2 CAR-T investigational therapy.
- Cellares will provide automated manufacturing and regulatory support for the program’s planned Investigational New Drug (IND) submission to the FDA.
Cellares, an Integrated Development and Manufacturing Organization (IDMO), has expanded its partnership with the University of Wisconsin (UW) School of Medicine and Public Health to support the clinical production and regulatory advancement of the university’s CRISPR-edited GD2 CAR-T investigational therapy. The therapy targets pediatric and adult solid tumors, with an initial focus on high-grade gliomas.
The collaboration builds on an initial partnership announced in April 2025, which focused on automating UW’s internally developed CAR-T process. Following what the parties described as strong performance and reliability in automated manufacturing, UW selected Cellares to support the program’s transition to clinical manufacturing.
Under the agreement, Cellares will use its Cell Shuttle™ end-to-end automated manufacturing platform and Cell Q™ automated quality control platform to produce the therapy. The company will also provide regulatory expertise to support preparation and submission of an Investigational New Drug application to the U.S. Food and Drug Administration, including contributions to the Chemistry, Manufacturing and Controls section. UW retains full ownership and leadership of the IND filing process.
The GD2 CAR-T program uses CRISPR gene editing to modify patient T cells via electroporation. The approach requires reproducible manufacturing to ensure batch consistency. The Cell Shuttle platform is designed to reduce manual handling and process variability, which may support advancement of the therapy into clinical trials.
“Academic medical centers originate many of the cell therapies that eventually reach patients, but the path from proof-of-concept to IND-ready production has historically added years to the development timeline. We believe that automated production can shorten that path and, through this clinical manufacturing collaboration with UW, we are committed to applying the Cell Shuttle and Cell Q platforms to support the full development lifecycle.”
Fabian Gerlinghaus, Co-founder and Chief Executive Officer of Cellares
