On September 16, 2026 Cellares, the first Integrated Development and Manufacturing Organization (IDMO), and GenomeFrontier Therapeutics, a Taiwanese cell therapy company developing novel virus-free CAR-T therapies, reported a partnership to evaluate automated manufacturing for GF-CART01, GenomeFrontier’s investigational CAR-T cell therapy, on Cellares’ Cell Shuttle platform.

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The collaboration will evaluate the translation of GenomeFrontier’s virus-free manufacturing process to the Cell Shuttle, with a focus on supporting transfection unit operation using Cellares’ proprietary 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 has demonstrated promising clinical data in Taiwan and is actively recruiting for a Phase 1 clinical trial in the United States.

"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 Chief Scientific Officer 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 United States."

"GenomeFrontier’s virus-free approach reflects the increasing complexity of next-generation cell therapy manufacturing," said 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. This partnership brings that capability to GenomeFrontier as it expands its program in the United States."

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.

Through the collaboration, Cellares and GenomeFrontier will evaluate the potential to automate GenomeFrontier’s process on the Cell Shuttle while maintaining the flexibility required for its virus-free approach. The companies aim to establish a manufacturing strategy capable of improving reliability, driving down manufacturing costs and improving patient access as GenomeFrontier advances its program.

(Press release, GenomeFrontier Therapeutics, SEP 16, 2026, View Source [SID1234670909])