Preclinical research aims to identify promising therapeutic candidates and determine if they meet safety and efficacy benchmarks to move into clinical trials. Flow cytometry can be used in both preclinical research and clinical trials but must be in compliance with Good Laboratory Practices (GLP) and Good Clinical Laboratory Practices (GCLP) in order to satisfy the regulatory requirements and industry standards for experimental therapies that may at some point be destined for treating patients. Consider these key elements required for flow cytometry assays for GLP/GCLP-compliance as you assess your preclinical and clinical research needs.

Instrumentation

A flow cytometer is essential for running a flow cytometry assay, and any electronic or computer equipment, including flow cytometers, used for preclinical or clinical studies must undergo instrument validation procedures in order to be compliant. Instrument validation assures that all components of the flow cytometer, including the optics and fluidics, are meeting specific validation parameters. In this way, the data produced by the flow cytometer can be considered reliable from the perspective of the instrumentation.

Assay

In addition to instrument validation, a GLP/GCLP-compliant flow cytometry assay also has to meet validation criteria in order to assure it is accurate, specific, and reproducible. Flow cytometry assays have many variables, including cell samples, staining reagents and buffers. During the validation process, you may need to analyze different cell sample standards and staining reagents in order to assure that you will have a sufficient amount of reagents to be used for future runs of your validated assay.

In some situations, you may not have access to a GLP/GCLP-compliant flow cytometer, or you may feel ill-equipped to establish a validated assay. Consider exploring your options to work with a contract research organization that specializes in flow cytometry. This may be a faster and more efficient way to satisfy your needs to run a GLP/GCLP-compliant flow cytometry assay.