Implementation of a quality management system for decentralized manufacturing of cell and gene therapy products - technical and regulatory considerations
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...
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| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Frontiers Media S.A.
2025-08-01
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| Series: | Frontiers in Medicine |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/articles/10.3389/fmed.2025.1591751/full |
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