MINI REVIEW article
Front. Bioeng. Biotechnol.
Sec. Bioprocess Engineering
Volume 13 - 2025 | doi: 10.3389/fbioe.2025.1644318
This article is part of the Research TopicDesign Strategies and Equipment Requirements for Efficient Process Development and Robust Manufacturing of Cell TherapiesView all 9 articles
Isolator-Based Point-of-Care Manufacturing: A Practical Solution for GMP-Compliant Cell and Extracellular Vesicles Therapy Production
Provisionally accepted
- 1YJ Biotechnology Co Ltd, New Taipei, Taiwan
- 2Department of Life Science, Fu-Jen Catholic University, New Taipei City, Taiwan
- 3Graduate Institute of Applied Science and Engineering, Fu-Jen Catholic University, New Taipei City, Taiwan
- 4Department of Electrical Engineering of I-Shou University, Kaohsiung, Taiwan
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Cell and extracellular vesicle (EV)-based therapies represent a promising frontier in regenerative medicine and immunotherapy. However, their clinical translation is often constrained by the complexities of Good Manufacturing Practice (GMP)-compliant production, particularly under centralized manufacturing models. This Perspective discusses the emerging role of decentralized, point-of-care (POC) manufacturing in enabling timely, scalable, and patient-specific delivery of cell and EV therapeutics, with a focus on isolator-based systems as core manufacturing infrastructure. We discuss current advances in closed-system technologies, regulatory frameworks, and quality control (QC) strategies supporting GMP compliance in decentralized environments. Real-world applications and case studies illustrate feasibility and translational impact. Isolator-based platforms offer modular, sterile, automation-compatible environments that support both autologous and selected allogeneic product manufacturing at clinical sites. These systems reduce contamination risks, lower facility requirements, and enable integration with realtime QC testing. Despite these advantages, challenges remain, including regulatory ambiguity, workforce training limitations, and quality assurance gaps in decentralized settings. Emerging solutions include automated closed-system bioreactors, digitalized QC workflows, and harmonized operational standards to ensure product safety and consistency. Strategic coordination among regulators, hospitals, and developers will be essential to overcome operational and compliance hurdles. With appropriate infrastructure, skilled personnel, and standardized processes in place, isolator-based POC manufacturing holds the potential to transform how advanced therapies are produced and deliveredultimately enhancing patient access to safe, effective, and personalized cell and EV-based treatments.
Keywords: cell therapy, Extracellular vesicles (EVs), GMP -Good Manufacturing Practice, Isolator, Point-of-care manufacturing
Received: 10 Jun 2025; Accepted: 11 Aug 2025.
Copyright: © 2025 Chiu, Wang and Wu. 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: Yu-Sung Chiu, YJ Biotechnology Co Ltd, New Taipei, Taiwan
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.