GeneFab Partners with RegCell to Support U.S. Clinical Manufacturing of Treg Therapies

• GeneFab will support RegCell in transferring and manufacturing its regulatory T cell therapy platform in the U.S., including clinical-grade production.

• The partnership includes end-to-end CRDMO services and explores future co-development of next-generation Treg therapies.

GeneFab, a cell and gene therapy-focused contract research, development, and manufacturing organisation (CRDMO), has entered into a partnership with RegCell to advance clinical manufacturing for regulatory T cell (Treg) therapies. The agreement supports RegCell’s expansion into the U.S. as it moves its Treg platform from Japan to GeneFab’s Alameda facility.

Under the collaboration, GeneFab will provide a full suite of CRDMO services including technology transfer, process development, scale-up, IND-enabling support, and clinical-grade manufacturing. The 92,000 square foot Alameda site features seven GMP clean rooms and will serve as the base for RegCell’s development activities for autoimmune indications such as autoimmune hepatitis.

According to the release, RegCell selected GeneFab based on its ability to deliver integrated services and its proximity to RegCell’s leadership team. GeneFab’s Bay Area presence is also described as a strategic advantage for biotech companies entering U.S. clinical trials. “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.

The agreement also includes discussions on potential co-development projects aimed at enhancing the safety and potency of future Treg therapies. GeneFab’s synthetic biology capabilities may be leveraged for integrated design improvements.

In parallel with the partnership, GeneFab is continuing to expand its infrastructure, with an additional 45,000 square feet planned at its Alameda location. The expansion supports the company’s strategy to scale its automation platforms and manufacturing capacity for pivotal trials and commercial readiness.