ArticleRegenerative therapy2016
Experience of contamination during autologous cell manufacturing in cell processing facility under the Japanese Medical Practitioners Act and the Medical Care Act.
Article in Regenerative therapy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 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
15 citing papers in PubMed.
- Biosafety-cabinet wipe-cleaning assessment system: Integration of visual, thermal, and pressure sensing.Regenerative therapy · 2026Article
- Microbiome-based profiles of airborne bacteria to support microbial risk assessment in cleanroom environments.Regenerative therapy · 2025Article
- Operator stress factors and cell contamination risks in cell processing facilities: An online survey-based analysis.Regenerative therapy · 2025Article
- Changeover method for biosafety cabinets using ozone gas.PloS one · 2025Article
- Microbes identified from monitoring cell manipulations in 5-year life of the Cell Factory G. Gaslini.Regenerative therapy · 2024Article
- Operator-derived particles and falling bacteria in biosafety cabinets.Regenerative therapy · 2024Article
- Volatile organic compounds and ionic substances contamination in cell processing facilities during rest period; a preliminary assessment of exposure to cell processing operators.Regenerative therapy · 2023Article
- Cross-contamination risk and decontamination during changeover after cell-product processing.Regenerative therapy · 2023Article
- Effect of disinfectants and manual wiping for processing the cell product changeover in a biosafety cabinet.Regenerative therapy · 2023Article
- Assessment of microbial contamination in laser materials processing laboratories used for prototyping of biomedical devices.Access microbiology · 2023Article
- Viability evaluation of layered cell sheets after ultraviolet light irradiation of 222 nm.Regenerative therapy · 2020Article
- The environmental risk assessment of cell-processing facilities for cell therapy in a Japanese academic institution.PloS one · 2020Article
- Understanding the formation and behaviors of droplets toward consideration of changeover during cell manufacturing.Regenerative therapy · 2019Article
- Variation in the manufacturing reproducibility of autologous cell-based products depending on raw material shipment conditions.Regenerative therapy · 2019Article
- Quantitative analysis of operators' flow line in the cell culture for controlled manual operation.Regenerative therapy · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Cell therapy and regenerative medicine technologies require strict cell manufacturing procedures to be defined and addressed. Maintenance of the aseptic environment is critical to preclude extrinsic contamination risks, similar to conventional pharmaceutical manufacturing. However, intrinsic contamination risks exist in all cell manufacturing processes owing to the use of cells as the raw materials that cannot be sterilized, thus giving rise to the primary and secondary risks of cell contamination and cross-contamination, respectively. Analysis of contamination risks was conducted on experienced batches (29,858 batches) for the production of immune cells derived from autologous blood mononuclear cells under the Medical Practitioners Act and the Medical Care Act in Japan. From these batches, 0.06% (18 cases) of contamination occurred, representing low probability of contamination incidence during cell processing. Almost all the causes of these contaminations were regarded to be from the collected blood (intrinsic contamination), and subsequent cross-contaminations were prevented, considering that the secondary contamination risk can be reduced by adequate managements of operational procedures for changeover in aseptic environment.
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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.