Cellares, GenomeFrontier to evaluate automated CAR-T manufacturing
Cellares, a self-described integrated development and manufacturing organization (IDMO) headquartered in South San Francisco, Calif., and GenomeFrontier Therapeutics, a Taiwan-based cell therapy company, are partnering to evaluate automated manufacturing of GenomeFrontier’s investigational CAR-T therapy GF-CART01.
The collaboration will assess how GenomeFrontier’s virus-free manufacturing process can be transferred to Cellares’ Cell Shuttle platform, including the use of an integrated electroporator for the transfection step. The work is intended to support GenomeFrontier’s U.S. clinical development program.
GenomeFrontier is developing GF-CART01 for B-cell malignancies, including diffuse large B-cell lymphoma, follicular lymphoma, primary mediastinal large B-cell lymphoma, and high-grade B-cell lymphoma. The company said it has generated clinical data in Taiwan and is recruiting patients for a Phase I trial in the U.S.
The companies will evaluate whether the manufacturing process can be automated while retaining the flexibility required for GenomeFrontier’s virus-free approach. The work will also examine manufacturing consistency and scalability as the program progresses through clinical development, with the aim of improving process reliability and reducing manufacturing costs.
The collaboration comes as Cellares continues to expand its work with cell therapy developers following the end of its partnership with Bristol Myers Squibb. BMS said Cellares’ Cell Shuttle system could not meet the requirements for commercial manufacturing of Breyanzi, a determination the company said was specific to that product and its established manufacturing process.
In a recent interview with Pharma Manufacturing, Cellares disputed that characterization and has pointed to its work with Cabaletta Bio, including manufacturing GMP drug product for an FDA-regulated clinical program. Cellares and Cabaletta have a 10-year commercial supply agreement covering automated manufacturing of Cabaletta’s investigational autologous CAR-T therapy rese-cel. Cellares said the companies have worked for more than three years to adapt the manufacturing process to the Cell Shuttle and support clinical manufacturing.
