San Francisco-based integrated development and manufacturing organization Cellares and Sonoma Biotherapeutics, a biotechnology company headquartered in Seattle, have entered into a collaboration to automate manufacturing of Sonoma’s lead engineered regulatory T-cell (Treg) therapy, SBT-77-7101, using the Cellares Cell Shuttle manufacturing platform.

SBT-77-7101 is an autologous CAR-Treg cell therapy currently in Phase 1 clinical development for poly-refractory rheumatoid arthritis (RA). According to the companies, it is the first Treg therapy to be manufactured using the Cell Shuttle platform, extending Cellares’ automated manufacturing technology into regulatory T-cell therapies.

Under the agreement, Cellares will adapt Sonoma Biotherapeutics’ manufacturing process for SBT-77-7101 to the Cell Shuttle platform and automate in-process and release testing using its Cell Q automated quality control system. The companies said the goal is to support manufacturing as the program advances toward later-stage clinical development and potential commercialization.

Cellares’ commercial-scale manufacturing facility in Bridgewater, New Jersey, is operational, with additional manufacturing sites under development in Europe and Japan to support global cell therapy production.

“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, CEO of Sonoma Biotherapeutics, said in a statement.

The announcement follows other recent developments at Cellares. In late June, the company was selected as one of seven participants in the FDA’s PreCheck pilot program, allowing its commercial-scale smart factory in New Jersey, to engage with regulators before commercial product filings. Cellares said the program is intended to reduce manufacturing risk ahead of commercial launches while supporting deployment of its automated Cell Shuttle manufacturing platform.