Treg cell therapy manufacturability: current state of the art, challenges and new opportunities

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Abstract

Autologous cell therapy is a revolutionary new paradigm in medicine. Significant advancements in personalized therapeutic treatments with engineered T cells have been seen across the immuno-oncology markets. The global market is expanding as new cell types treat other conditions, like autoimmunity and transplant rejection. Key to the success of these novel cell therapies is manufacturability; ensuring robust processes that can reliably deliver treatments that meet the medical needs. Using the expertise and experience of the current state of Regulatory T cell (Treg) manufacturing at Sonoma Biotherapeutics as a prototypical case, we review manufacturing challenges and opportunities to ensure success.

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Stoops, J., Morton, T., Powell, J., Pace, A. L., & Bluestone, J. A. (2025). Treg cell therapy manufacturability: current state of the art, challenges and new opportunities. Frontiers in Immunology. Frontiers Media SA. https://doi.org/10.3389/fimmu.2025.1604483

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