Flow Cytometry Applications in Clinical Trials

This document is a technical report discussing the role of flow cytometry in clinical trials, particularly in the pharmaceutical and biotechnology sectors. It outlines the necessity for sponsors to utilize flow cytometry to analyze the human immune system at a single-cell level, which is crucial for understanding disease mechanisms and therapeutic responses. The report details how flow cytometry can facilitate the pharmacokinetics (PK) and pharmacodynamics (PD) of therapies such as CAR-T cell therapy, and how it can be employed to assess drug efficacy and safety through receptor occupancy measurements. Additionally, it explains the advantages of flow cytometry in identifying rare tumor cells and evaluating engraftment success. The document also touches on the relationship between modern immunology and flow cytometry, emphasizing the importance of understanding immune cell interactions and biomarker profiles in clinical trials. Furthermore, it discusses future trends in flow cytometry technology and its potential advancements in both in vitro diagnostics and research use only.