Understanding the contribution of operator measurement variability within Flow Cytometry data analysis for Quality Control of Cell and Gene Therapy manufacturing
| Autor: | Julian Braybrook, Jon N. Petzing, Bo Kara, Nick Medcalf, Karen Coopman, Jonathan Campbell, Sandro Silva-Gomes, Rebecca Grant |
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| Rok vydání: | 2020 |
| Předmět: |
Computer science
media_common.quotation_subject 02 engineering and technology computer.software_genre 01 natural sciences Flow cytometry Operator (computer programming) Histogram 0202 electrical engineering electronic engineering information engineering medicine Quality (business) Electrical and Electronic Engineering Control (linguistics) Instrumentation media_common medicine.diagnostic_test Applied Mathematics 020208 electrical & electronic engineering 010401 analytical chemistry Condensed Matter Physics 0104 chemical sciences Control limits Outlier Measurement uncertainty Data mining computer |
| Zdroj: | Measurement. 150:106998 |
| ISSN: | 0263-2241 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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