AUTHOR=Stoops Janelle , Morton Tara , Powell James , Pace Amanda L. , Bluestone Jeffrey A. 

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

JOURNAL=Frontiers in Immunology

VOLUME=Volume 16 - 2025

YEAR=2025

URL=https://www.frontiersin.org/journals/immunology/articles/10.3389/fimmu.2025.1604483

DOI=10.3389/fimmu.2025.1604483

ISSN=1664-3224

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.