Cellares, an integrated development and manufacturing organization (IDMO), and GenomeFrontier Therapeutics, a Taiwanese cell therapy company developing virus-free CAR T therapies, formed a partnership to evaluate automated manufacturing for GF-CART01, GenomeFrontier’s investigational CAR T-cell therapy, on Cellares’ Cell Shuttle platform.
The collaboration will focus on the translation of GenomeFrontier’s manufacturing process to the Cell Shuttle, with an emphasis on supporting transfection unit operation using Cellares’ integrated electroporator. The partnership marks Cellares’ first development collaboration in Asia and is intended to support GenomeFrontier’s U.S. clinical initiative as it advances GF-CART01.
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 reports that it has demonstrated promising clinical data in Taiwan and is now recruiting for a Phase I clinical trial in the U.S.
“As we advance GF-CART01, it is important that our manufacturing strategy can support both clinical development and future scale,” said Sareina Wu, PhD, founder, CEO, and CSO of GenomeFrontier. “Our virus-free approach is central to the development of GF-CART01, and this collaboration with Cellares allows us to evaluate how that process can be translated to an automated manufacturing platform as we expand our clinical development in the U.S.”
“GenomeFrontier’s approach reflects the increasing complexity of next-generation cell therapy manufacturing,” added Fabian Gerlinghaus, co-founder and CEO of Cellares. “The Cell Shuttle is built to automate complex processes, including electroporation-based workflows, with the scalability and reliability needed as therapies advance through clinical development.”
Autologous CAR T manufacturing remains labor-intensive, variable and difficult to scale, creating challenges for clinical development, manufacturing reliability, cost, and ultimately patient access. The Cell Shuttle is an end-to-end automated cell therapy manufacturing platform designed to improve the scalability and reliability of autologous cell therapy manufacturing, according to Cellares.
