- Cellares and Sonoma Biotherapeutics have entered into a collaboration to automate the manufacturing of Sonoma Biotherapeutics’ lead regulatory T cell (Treg) therapy, SBT-77-7101, using the Cellares Cell Shuttle platform.
- The collaboration aims to support late-stage clinical development and commercial readiness by automating manufacturing and quality control for the Phase 1 cell therapy program.
Cellares and Sonoma Biotherapeutics have announced a collaboration to automate the manufacturing of Sonoma Biotherapeutics’ lead cell therapy candidate, SBT-77-7101, on the Cellares Cell Shuttle platform. SBT-77-7101 is an autologous CAR-Treg cell therapy currently in Phase 1 clinical development for poly-refractory rheumatoid arthritis. The collaboration expands the Cell Shuttle platform to support regulatory T cell (Treg) therapies, a cell therapy modality requiring precise manufacturing and analytical control.
Under the agreement, Cellares will transfer Sonoma Biotherapeutics’ proprietary manufacturing process for SBT-77-7101 onto the Cell Shuttle platform and automate in-process and release testing using Cell Q™, its automated quality control system. The companies said the collaboration is intended to improve manufacturing efficiency and support the program’s progression toward late-stage clinical development and commercial manufacturing.
“Tregs are uniquely sensitive to the manufacturing process, and the precision of our proprietary process drives their superior function. Cellares brings the Cell Shuttle platform, and global infrastructure to help us deliver on our clinical ambitions at scale for the hardest-to-treat RA patients.”
Stephen Dilly, MBBS, PhD, President, Chief Executive Officer and Board Chair of Sonoma Biotherapeutics
Cellares said its commercial-scale Integrated Development and Manufacturing Organization (IDMO) Smart Factory in Bridgewater, New Jersey, together with facilities under construction in Europe and Japan, provides a global manufacturing network to support cell therapies from Phase 1 through commercial production. The collaboration is intended to combine Sonoma Biotherapeutics’ expertise in Treg therapies with Cellares’ automated manufacturing platform to support future clinical and commercial supply.
The companies stated that the collaboration is designed to address the manufacturing challenges associated with Treg therapies by combining automated manufacturing and quality control capabilities with a global manufacturing infrastructure, supporting the advancement of SBT-77-7101 toward commercialization.
