GeneFab, a cell and gene therapy-focused contract research, development, and manufacturing organization (CRDMO), has partnered with RegCell, a biotech company advancing regulatory T cell (Treg) therapies for autoimmune diseases, to support the tech transfer and clinical manufacturing of RegCell’s Treg platform as it transitions from Japan to GeneFab’s manufacturing facility in Alameda.

GeneFab will provide full cohesive CRDMO support, including technology transfer, process development, scale-up, IND-enabling activities, and clinical-grade manufacturing at its 92,000 square foot Alameda facility, which includes seven GMP clean rooms. It will also support RegCell to accelerate U.S. clinical trials for autoimmune indications, including autoimmune hepatitis.

“This collaboration embodies what we do best, partnering with cutting-edge therapeutic developers to accelerate their journey to the clinic,” said Dr. Philip Lee, CEO at GeneFab. “RegCell has developed a best-in-class platform to generate stable, epigenetically reprogrammed, antigen-specific Tregs, and our team is proud to help bring that momentum to the U.S.”

In addition, beyond the current program, the two companies are exploring co-development opportunities to further optimize Treg therapies, harnessing GeneFab’s expertise in synthetic biology.

“These initiatives may include integrative designs and optimizations aimed at improving the safety and potency of the next generation of therapies,” said Dr. Duncan Liew, Senior VP of Business Development at GeneFab.

Dr. Michael McCullar, CEO, RegCell, commented: “This partnership marks the next step of our mission to bring our groundbreaking immunology therapy to market and transform outcomes for patients with autoimmune diseases.”

RegCell recently closed an oversubscribed seed round, including funding from Japan’s Agency for Medical Research and Development (AMED), and completed a headquarters transition to the U.S. The funding will accelerate the development of RegCell’s epigenetic reprogramming platform through transformative clinical milestones in the U.S. and further propel RegCell’s commitment and mission to bring the advancements of Treg technologies to the forefront of cell therapy innovations.

As part of its broader growth strategy, GeneFab is investing in automation platforms and scaling capabilities to support pivotal trials and commercial readiness. The build-out of an additional 45,000 square feet at its Alameda site is planned, aligning with the company’s vision of enabling cost-effective and scalable access to advanced cell therapies.