Assessment of Automated Flow Cytometry Data Analysis Tools within Cell and Gene Therapy Manufacturing.

ABSTRACT: Flow cytometry is widely used within the manufacturing of cell and gene therapies to measure and characterise cells. Conventional manual data analysis relies heavily on operator judgement, presenting a major source of variation that can adversely impact the quality and predictive potential of therapies given to patients. Computational tools have the capacity to minimise operator variation and bias in flow cytometry data analysis; however, in many cases, confidence in these technologies has yet to be fully established mirrored by aspects of regulatory concern. Here, we employed synthetic flow cytometry datasets containing controlled population characteristics of separation, and normal/skew distributions to investigate the accuracy and reproducibility of six cell population identification to

SUBMITTER: Cheung M 

PROVIDER: S-EPMC8955358 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature