ArticleJournal of clinical microbiology2021
Comprehensive Study Identifies a Sensitive, Low-Risk, Closed-System Model for Detection of Fungal Contaminants in Cell and Gene Therapy Products.
Article in Journal of clinical microbiology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 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
8 citing papers in PubMed, 12 citations in OpenAlex.
- Evaluation of an automated blood culture detection system for sterility testing of cellular and gene therapy products.Microbiology spectrum · 2026Article
- Finding the middle way: rethinking cGMP for sterility testing of cellular therapy products in minimal manipulation settings.Journal of clinical microbiology · 2025Article
- Reply to "Finding the middle way: rethinking cGMP for sterility testing of cellular therapy products in minimal manipulation settings".Journal of clinical microbiology · 2025Article
- Comparative Evaluation of Temperature, Bottle Type, and Amphotericin B on Fungal Detection in Corneal Preservation Media Using the BACT/ALERT SystemMicroorganisms · 2025Article
- Optimized preparation pipeline for emergency phage therapy against Pseudomonas aeruginosa at Yale University.Scientific reports · 2024Article
- Sterility Testing for Hematopoietic Stem Cells.Journal of clinical microbiology · 2023Review
- Growth Performance and Recovery of NosocomialMicroorganisms · 2022Article
- Validation of an automated quality control method to test sterility of two advanced therapy medicinal products: Mesenchymal stromal cells and their extracellular vesicles.Hematology, transfusion and cell therapyArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors at 2 institutions in 1 country.
Funding
Abstract
The U.S. Food and Drug Administration (FDA) regulates manufacturing and testing of advanced therapeutic medicinal products (ATMPs) to ensure the safety of each product for human use. Gold-standard sterility testing (USP<71>) and alternative blood culture systems have major limitations for the detection of fungal contaminants. In this study, we evaluated the performance of
Indexed as
Identifiers
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.