METHODS article
Front. Med.
Sec. Regulatory Science
Volume 12 - 2025 | doi: 10.3389/fmed.2025.1591751
This article is part of the Research TopicDesign Strategies and Equipment Requirements for Efficient Process Development and Robust Manufacturing of Cell TherapiesView all 7 articles
Implementation of a Quality Management System for decentralized manufacturing of cell and gene therapy products -technical and regulatory considerations_ von der Leyen et al. -1 -Implementation of a Quality Management System for decentralized manufacturing of cell and gene therapy products -technical and regulatory considerations
Provisionally accepted
- 1Orgenesis Inc, Germantown, MD, United States
- 2Hospital Clinic of Barcelona, Barcelona, Catalonia, Spain
- 3Clinic for Haematology, Oncology and Rheumatology, Clinic for Internal Medicine V, Heidelberg University Hospital, Heidelberg, Baden-Württemberg, Germany
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Decentralized manufacturing has emerged as a promising approach to improve the accessibility and scalability of cell and gene therapy products, particularly for autologous treatments. This paper proposes a comprehensive Quality Management System (QMS) framework tailored to decentralized cell therapy manufacturing, integrating current Good Manufacturing Practice (cGMP) principles and regulatory oversight through a centralized Control Site model. The Control Site serves as the regulatory nexus, maintaining POCare Master Files and ensuring consistency across multiple decentralized manufacturing sites. Decentralized manufacturing has the potential to facilitate accessibility for cell and gene therapies. The proposed model leverages automated, closed-system technologies to minimize process variability and hardware deviations, thereby enhancing product quality and regulatory compliance. The Control Site holds functional roles like primary focus point for interaction with regulatory agencies, provision of quality assurance, qualified person (QP) and oversight systems. It also maintains the POCare Master File for the individual POCare GMP manufacturing sites. A standardized GMP manufacturing platform (e.g., deployable as prefabricated units allowing quick expansion) and an overarching training platform should guarantee quality standards. Key regulatory expectations will be discussed, e.g. the demonstration of consistency and comparability, the central role of QP (as proposed in the context of the European Commission’s Pharma strategy), and the Control Site as single point of contact for competent authorities. This approach aims to streamline cell therapy production at or near point of care, supporting rapid and cost-effective clinical implementation.
Keywords: Decentralized manufacturing, Cell and Gene Therapy, Control site, point of care platform, Gmp compliance, Quality Management System, regulatory oversight
Received: 12 Mar 2025; Accepted: 04 Jul 2025.
Copyright: © 2025 Von Der Leyen, Delgado, Mazouz, Schmitt and Caplan. 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: Heiko Von Der Leyen, Orgenesis Inc, Germantown, MD, 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.