REVIEW article

Front. Immunol.

Sec. T Cell Biology

Volume 16 - 2025 | doi: 10.3389/fimmu.2025.1604483

This article is part of the Research TopicAdvancing Treg Cell Therapy: A Comprehensive Review SeriesView all articles

Treg Cell Therapy Manufacturability: Current State of the Art, Challenges and New Opportunities

Provisionally accepted
Janelle  StoopsJanelle Stoops*Tara  MortonTara MortonJames  PowellJames PowellAmanda  L. PaceAmanda L. Pace*Jeffrey  A. BluestoneJeffrey A. Bluestone
  • Sonoma Biotherapeutics, South San Francisco, United States

The final, formatted version of the article will be published soon.

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 immunooncology 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.

Keywords: Treg - regulatory T cell, CAR (chimeric antigen receptor) T cell therapy2, cell therapy manufacturing, TCR - T cell receptor, Autoimmune Diseases

Received: 01 Apr 2025; Accepted: 30 Apr 2025.

Copyright: © 2025 Stoops, Morton, Powell, Pace and Bluestone. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence:
Janelle Stoops, Sonoma Biotherapeutics, South San Francisco, United States
Amanda L. Pace, Sonoma Biotherapeutics, South San Francisco, United States

Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.