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• W2971314786 abstract "Flow Cytometry is a measurement technique used in Quality Control and in-process measurements of biomanufactured Cell and Gene Therapy products. However, it contains a number of sources of measurement variation at; sample preparation, instrument setup, analysis, and post-analytical data analysis stages. The latter sees variation introduced from operator subjectivity, which is investigated here to understand what effects the interpretation of diagrammatical protocols have on inter-operator analysis. 36 operators from different sites were given a series of histograms to analyse, gating a shifting peak. This was repeated with diagrammatical protocols to apply gates which reduced inter-operator variation by up to 92%. Various control limits include and exclude different results and when adjusted with a log transform differences in outlier discrimination have been found. This research supports the use of Flow Cytometry diagrammatical protocols to reduce the contribution of inter-operator variation and measurement uncertainty associated within Cell and Gene Therapy manufacturing scenarios." @default.
• W2971314786 created "2019-09-05" @default.
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• W2971314786 date "2020-01-01" @default.
• W2971314786 modified "2023-10-03" @default.
• W2971314786 title "Understanding the contribution of operator measurement variability within Flow Cytometry data analysis for Quality Control of Cell and Gene Therapy manufacturing" @default.
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• W2971314786 doi "https://doi.org/10.1016/j.measurement.2019.106998" @default.
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