Cellares, the first Integrated Development and Manufacturing Organization (IDMO), and GenomeFrontier Therapeutics, a Taiwanese cell therapy company developing novel virus-free CAR-T therapies, today announced 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.
About Cellares
Cellares is the first Integrated Development and Manufacturing Organization (IDMO), providing global cell therapy development and manufacturing services through an Industry 4.0 approach to the mass manufacture of the living drugs of the 21st century. The company enables drug sponsors to develop, scale, and commercialize cell therapies with the capacity, reliability, and economics required to meet total patient demand.
Cellares’ fully automated platforms — Cell Shuttle® for end-to-end cell therapy manufacturing and Cell Q™ for automated in-process and release quality control — are deployed across its network of IDMO Smart Factories worldwide. These technologies deliver industry-leading manufacturing economics, higher process success rates, and the ability to produce up to 10× more cell therapy batches than conventional CDMOs with comparable footprint and headcount, resulting in the lowest cost of manufacturing in the industry.
The Cell Shuttle is the first cell therapy manufacturing platform to receive the FDA’s Advanced Manufacturing Technology (AMT) designation, and has demonstrated a 100% automation success rate across more than a dozen automated processes. Cellares was also accepted into the FDA’s inaugural Manufacturing PreCheck cohort, the only cell therapy platform among seven companies nationwide, giving Cellares early and ongoing engagement with the FDA during facility development and application submission periods, compressing regulatory timelines and de-risking the path to commercial-scale production for the drug sponsors building on Cellares’ platform.
Cellares has achieved key clinical validation milestones, including a successful IND Amendment enabling active clinical manufacturing on the Cell Shuttle platform, and the successful dosing of first patients in a partner clinical trial — marking the platform’s transition from development-stage technology to clinically validated manufacturing infrastructure. These milestones span multiple therapeutic areas and cell therapy modalities, including both oncology and autoimmune indications.
Headquartered in South San Francisco, California, Cellares operates its first commercial-scale IDMO Smart Factory in Bridgewater, New Jersey, with additional facilities under construction in Europe and Japan. Through its global manufacturing network, Cellares is purpose-built to support both clinical and commercial programs and to expand access to life-saving cell therapies worldwide. For more information, visit www.cellares.com and follow Cellares on LinkedIn.
About GenomeFrontier Therapeutics
GenomeFrontier Therapeutics is an innovation-driven, clinical-stage biotechnology company focused on advancing next-generation gene and cell therapies through proprietary non-viral technologies. At the core of the company is Quantum Engine™, an integrated cell-engineering system built on four proprietary platforms spanning gene design, genomic integration, gene delivery, and cell expansion. Quantum Engine™ is designed to enable efficient and flexible multiplex engineering for the development of potent, durable, and scalable cell therapies.
GenomeFrontier is leveraging Quantum Engine™ to advance a growing pipeline of CAR-T therapies for hematologic malignancies and solid tumors. Its lead program, GF-CART01, is an autologous, dual-targeting CAR-T therapy currently being evaluated clinically for B-cell malignancies, with an approach designed to address key challenges of conventional CAR-T therapies, including antigen escape and limited persistence.
Headquartered in Taiwan, GenomeFrontier is advancing its pipeline and technology through strategic collaborations and partnerships across key global markets, with the vision of bringing innovative, next-generation gene and cell therapies to patients worldwide.
For more information, visit genomefrontier.com and follow us on LinkedIn.
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