Automating Hope: Cellares and Sonoma Bio Forge Path for Mass-Produced Treg Therapy

SOUTH SAN FRANCISCO, CA & SEATTLE, WA – July 13, 2026

In a move that signals a pivotal shift in the production of next-generation medicines, Cellares and Sonoma Biotherapeutics have announced a collaboration to industrialize the manufacturing of a promising new cell therapy. The partnership will see Sonoma Bio’s engineered regulatory T cell (Treg) therapy, SBT-77-7101, automated on Cellares’ cutting-edge Cell Shuttle platform. This isn't just a technical upgrade; it's a foundational step toward solving the biggest hurdle in the cell therapy revolution: manufacturing at scale.

For patients with severe, treatment-resistant rheumatoid arthritis, this collaboration represents a tangible step toward accessing a potentially life-altering treatment. For the biotech industry, it serves as a critical test case for whether the “living drugs” of the 21st century can finally be produced with the efficiency and reliability of traditional pharmaceuticals. By tackling one of the most technically demanding cell types, the two companies are aiming to create a blueprint for the future of advanced therapy commercialization.

Cracking the Code of Complex Cell Manufacturing

The promise of cell therapies, particularly those using a patient's own modified cells, has long been tempered by the immense complexity of their production. Treg therapies are a case in point. These cells, which act as the immune system's peacekeepers, are notoriously difficult to manufacture. They are rare, comprising only a small fraction of a person's T cells, and are highly sensitive to their environment. Preserving their unique identity and suppressive function throughout the manufacturing process is paramount.

Traditionally, this has required a highly manual, labor-intensive process conducted by specialized scientists in expensive cleanroom facilities. The process is prone to variability, has a high risk of contamination from open handling, and simply does not scale. These challenges create a significant bottleneck, driving up costs to astronomical levels and severely limiting the number of patients who can be treated. It’s a problem that has plagued the industry, threatening to keep groundbreaking science confined to small clinical trials.

This is the challenge Cellares was built to solve. Operating as the industry’s first Integrated Development and Manufacturing Organization (IDMO), the company has developed a fully automated, closed system designed to industrialize cell therapy production. Its Cell Shuttle platform, which recently received the FDA's prestigious Advanced Manufacturing Technology (AMT) designation, can manage the entire end-to-end manufacturing process for up to 16 patient batches simultaneously. Paired with Cell Q, an automated quality control workcell, the system aims to slash manufacturing costs by up to 70% while increasing throughput tenfold compared to conventional methods. By replacing manual processes with robotic precision, Cellares aims to dramatically increase process success rates and ensure product consistency.

“Tregs are among the most technically demanding cell types to manufacture reliably,” said Fabian Gerlinghaus, Co-founder and CEO of Cellares. “We are honored to partner with SonomaBio, the industry leader in this field, and demonstrate that our platform, which has already been robustly validated for CAR-T therapies in the clinic, can directly translate to Tregs.”

A New Frontier for Autoimmune Disease Treatment

Behind the manufacturing technology lies a profound human need. The collaboration’s initial focus, SBT-77-7101, is being developed for patients with poly-refractory rheumatoid arthritis (RA). These are individuals who have cycled through and failed multiple treatments, leaving them with chronic pain, inflammation, and limited options. For this population, the unmet medical need is immense.

Unlike conventional RA treatments that broadly suppress the immune system, Sonoma Bio’s CAR-Treg therapy is designed to restore balance. It involves harvesting a patient’s own Tregs, engineering them with a Chimeric Antigen Receptor (CAR) to target sites of inflammation, and reinfusing them to calm the autoimmune attack. It’s a highly targeted approach that holds the potential for durable, long-term remission by addressing the root cause of the disease.

However, the most brilliant scientific breakthrough is of little value if it cannot reach the patients who need it. The partnership with Cellares is the crucial link between clinical promise and real-world access. By automating the delicate and complex manufacturing process, the collaboration aims to ensure that SBT-77-7101 can be produced reliably and cost-effectively enough to support late-stage clinical trials and, ultimately, commercial launch.

“Tregs are uniquely sensitive to the manufacturing process, and the precision of our proprietary process drives their superior function,” noted Stephen Dilly, MBBS, PhD, President and CEO of Sonoma Biotherapeutics. “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.”

The Rise of the IDMO and a New Business Blueprint

This partnership is more than a technical handshake; it showcases a new strategic model for the biopharma industry. Cellares’ IDMO concept moves beyond the traditional fee-for-service role of a Contract Development and Manufacturing Organization (CDMO). Instead, it offers an integrated, end-to-end solution that encompasses process development, manufacturing, quality control, and regulatory support, all built upon a standardized, automated technology platform.

For a clinical-stage company like Sonoma Bio, this model offers a way to de-risk its path to market. Rather than building its own multi-million-dollar manufacturing facility or wrestling with technology transfer to a conventional CDMO, it can leverage Cellares' established, globally expanding network of “Smart Factories.” With a commercial-scale facility already operational in New Jersey and more planned for Europe and Japan, Cellares provides a clear line of sight from Phase 1 trials to global commercial supply.

Sonoma Bio brings its own formidable expertise to the table. Founded by pioneers in Treg biology, including scientists whose foundational research was recognized with a Nobel Prize, the company has one of the most advanced Treg programs in the clinic. Its deep scientific understanding is critical for translating the nuanced biological process onto an automated platform. This synergy—deep therapeutic expertise combined with industrial-scale manufacturing prowess—is what makes the collaboration so compelling.

Navigating the Path from Lab to Patient

Successfully bringing a novel cell therapy to market requires navigating a complex regulatory landscape. Here, too, the partnership is built on a forward-thinking strategy. Cellares has actively engaged with regulators, earning the FDA’s AMT designation for its Cell Shuttle and a spot in the agency’s inaugural Manufacturing PreCheck Cohort. These programs are designed to help the FDA become familiar with new manufacturing technologies early, which can streamline the regulatory review process for any therapy produced on the platform.

By adopting this automated, regulatory-vetted platform, Sonoma Bio can build quality and consistency into its manufacturing process from the ground up. This proactive approach to “Quality by Design” mitigates risks that have historically derailed promising therapies in late-stage development. It addresses the manufacturing question not as an afterthought, but as a core component of the clinical development strategy.

For an industry grappling with the challenge of making personalized medicine a widespread reality, the Cellares-Sonoma Bio alliance offers a powerful example of the way forward. It demonstrates that by combining deep biological insight with advanced industrial automation, it is possible to build a scalable and commercially viable path for even the most complex living drugs.