ReviewMolecular therapy : the journal of the American Society of Gene Therapy2025
Redefining quality in cell and gene therapies: Lessons from implementing electronic QMS in academic cGMP facility.
Review in Molecular therapy : the journal of the American Society of Gene Therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
5 citing papers in PubMed.
- From production to bedside: A tiered QC framework for regulatory alignment and analytical comparability in decentralized CGT.Regenerative therapy · 2026Review
- Securing raw materials, reagents, and consumable supplies in the academic bioproduction UNITC network: because the chain is only as strong as its weakest link.Bone marrow transplantation · 2026Article
- Stem cell treatments for female reproductive disorders: a comprehensive review.Journal of ovarian research · 2025Review
- The clinical quality management system of advanced therapy medicinal products in the hospital setting: A scoping review.Molecular therapy. Methods & clinical development · 2025Review
- A hierarchical and configurational analysis of Health Technology Assessment outcomes for cell and gene therapies.Frontiers in pharmacology · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Manufacturing cell and gene therapies (CGTs) involves complex processes that require robust quality management, especially within academic current Good Manufacturing Practice (cGMP) facilities, where resources are often limited. Traditional paper-based quality management systems (QMSs), while initially convenient, often become burdensome, leading to errors, poor traceability, and compliance risks. Electronic QMSs (eQMSs) are gaining recognition for their ability to centralize and automate key quality processes, significantly enhancing operational efficiency and regulatory readiness. Through an in-depth case study of the University of Southern California and Children's Hospital of Los Angeles academic cGMP facility, this review demonstrates tangible improvements achieved by adopting an eQMS. Practical insights gained from this experience are shared, including careful selection of eQMS platforms, phased rollout strategies, and comprehensive staff training. The review also addresses common implementation challenges and suggests practical solutions to overcome them. Lessons learned and strategies discussed here can serve as valuable guidance for other academic institutions considering eQMS adoption. Ultimately, embracing an eQMS enables academic CGT manufacturers to operate more efficiently and stay ahead in a fast-moving field.
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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.