Recommendations for the validation of flow cytometric testing during drug development: I instrumentation

Journal of Immunological Methods
Cherie L GreenThomas W Mc Closkey

Abstract

Flow cytometry is a powerful and flexible analytical tool used during all stages of drug development. While substantial effort is invested in development and validation of analytical methods, instrument validation is often neglected. Flow cytometers are evolving at a pace that surpasses the protracted timeline of drug discovery and development. Therefore, it becomes fundamentally important to the success of the study to document the validated state of the flow cytometer and verify data integrity at the time of study conduct. It is important to bear in mind that validation strategies are critical components of the entire process involved in bringing new therapeutic options to the medical community; drugs which eventually manifest as successful new treatments for those individuals afflicted with disease. Formal industry guidance is provided through Good Laboratory Practices [GLP], which require validation of all computerized systems and equipment used to support pre-clinical studies for regulatory submissions. Key elements of instrument validation processes have been delineated through guidance documents published by regulatory agencies and industry working groups to support the rigorous compliance needs of GLP. However, most tes...Continue Reading

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Citations

May 22, 2013·Veterinary Immunology and Immunopathology·Brandon M ZeiglerJohn Farmer
Nov 14, 2015·Cytometry. Part B, Clinical Cytometry·Cherie L GreenVirginia Litwin
Feb 11, 2015·Journal of Immunological Methods·Lynette BrownVirginia Litwin
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Jan 13, 2021·Cytometry. Part B, Clinical Cytometry·Karen J QuadriniThomas W McCloskey
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Jun 19, 2021·Expert Opinion on Biological Therapy·Alessandra AudiaChelsea Riveley
Sep 17, 2021·Bioanalysis·Christèle GonneauVirginia Litwin

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