GeneFab and RegCell Announce Strategic Partnership to Advance Autoimmune Cell Therapy into U.S. Clinical Trials
- GeneFab will lead U.S. process development, GMP manufacturing, and clinical supply for RegCell's lead Treg program.
- Partnership accelerates RegCell's path into U.S. clinical trials for autoimmune indications.
- Builds on GeneFab's established platform for autologous and allogeneic Treg cell therapy.
ALAMEDA, Calif. — May 7, 2025. GeneFab today announced a strategic partnership with RegCell, a biotechnology company advancing regulatory T cell (Treg) therapies for autoimmune diseases, to bring RegCell's lead program into U.S. clinical trials.
Under the partnership, GeneFab will serve as RegCell's U.S. CRDMO partner — providing integrated process development, analytical development, GMP manufacturing, and clinical supply support from GeneFab's purpose-built facility in Alameda, California.
Why Treg therapies
Regulatory T cells are a specialized subset of the immune system responsible for maintaining tolerance — preventing the immune system from attacking the body's own tissues. Engineered Treg therapies have emerged as one of the most promising next-generation approaches for autoimmune diseases, organ transplantation, and other conditions driven by inappropriate immune activation. They have the potential to restore immune balance with the durability of a cell therapy and the specificity of a designed biologic.
But Treg programs come with manufacturing challenges that are distinct from CAR-T or CAR-NK. Purity, phenotypic stability, suppressive function, and donor-to-donor consistency must all be carefully controlled. That's where GeneFab's experience matters.
What GeneFab brings
GeneFab's Treg manufacturing platform supports both autologous and allogeneic programs across the full unit operation chain — isolation, transduction, expansion, formulation, fill, and cryopreservation. Our analytical capabilities include the full release panel for cell therapy drug products: flow cytometry, dPCR/qPCR for vector copy number, T-cell suppression assays for potency, and complete safety testing.
The partnership leverages GeneFab's 42,000 sq ft cGMP facility in Alameda — designed with two segregated cleanroom wings to support parallel programs — alongside our integrated SynBio research center in South San Francisco.
About RegCell
RegCell is a biotechnology company focused on developing engineered Treg cell therapies for autoimmune diseases. RegCell's platform combines proprietary expansion methods, engineered antigen specificity, and rigorous phenotypic characterization to produce Treg cell products designed for durable clinical benefit.