ArticleFrontiers in medicine2025
Implementation of a quality management system for decentralized manufacturing of cell and gene therapy products - technical and regulatory considerations.
Article in Frontiers in medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
4 citing papers in PubMed.
- Review
- From production to bedside: A tiered QC framework for regulatory alignment and analytical comparability in decentralized CGT.Regenerative therapy · 2026Review
- Fecal Immunochemical Test and Multitarget Stool DNA Testing for Colorectal Cancer Screening in Real-World Practice: A Literature Review.Journal of clinical medicine · 2026Review
- Developing a consensus-based competency framework for hospital pharmacists in the management of advanced therapy medicinal products (ATMPs): a modified delphi study in Macao.BMC medical education · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.