Flow cytometry (FC) is a sensitive and highly customizable technique that can be used in both preclinical and clinical studies. How do you ensure that flow cytometry data is reliable, consistent and can meet the standards required for regulatory requirements or clinical trials? Implementing quality control (QC) procedures is a widely accepted strategy to guarantee that your flow cytometry data is handled in a rigorous and consistent manner and can be used for regulatory compliance and clinical trial evaluations.
Flow Cytometry Blog
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.
Data is the cornerstone of the drug development and clinical trial processes and is critical to determining which candidates move forward. Currently, many drugs and biologics under development, operate by altering the immune system, and flow cytometry is a widely used technique for gathering a wide range of data about the immune response. Flow cytometry can be performed in full compliance with Good Laboratory Practice (GLP) standards, which make it an ideal tool for pre-clinical and clinical studies.
The emergence of biologic-based therapeutics has transformed the treatment of cancer, autoimmune disease and other disorders. These biologically active molecules can alter the immune response and change disease trajectories, so many of the tests that are used to assess their function must examine biological functions. These molecules typically bind to specific receptors on immune cells, which may block or activate a specific response depending on the mode of action.
Many basic and clinical immunology studies that focus on T cells include proliferation assays in order to determine if T cells are capable of proliferating under different in vitro or in vivo conditions. Flow cytometry is the ideal approach for measuring T cell proliferation and a suite of staining products now exist that allow you to incorporate a proliferation dye into your existing flow cytometry staining panel. As with all flow cytometry staining protocols, be sure to do a pilot experiment to titrate your staining reagents and determine how many cells you need to run during your flow cytometry acquisition to have enough events for an accurate proliferation measurement.