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Related Concept Videos

Flow Cytometry01:23

Flow Cytometry

The development of flow cytometry techniques began in 1934 with initial attempts by Andrew Moldavan, a bacteriologist who counted the cells in a flowing capillary system. Moldavan pumped cells through a capillary tube focused under a microscope for visualization. The invention of photometry allowed the measurement of differentially-stained cells, and Louis Kamentsky developed the first multiparameter flow cytometer in 1965 to identify and count the cancer cells in cervical tissue specimens.
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A Semi-automated Approach to Preparing Antibody Cocktails for Immunophenotypic Analysis of Human Peripheral Blood
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A Modular High-Parameter Flow Cytometry Framework: Pre-Analytical Optimization and Validation for Clinical Research.

Jennifer Scott1, Iva Lelios2, Tobias Rutishauser2

  • 1Translational Science Department, IQVIA Laboratories, Livingstone, UK.

Cytometry. Part a : the Journal of the International Society for Analytical Cytology
|June 26, 2026
PubMed
Summary
This summary is machine-generated.

A modular high-parameter flow cytometry (hpFCM) approach enhances immune profiling in drug development. This adaptable assay ensures data reproducibility and supports biomarker discovery throughout clinical trials.

Keywords:
biomarkersclinical cytometrycontext of usehigh‐parameter flow cytometry assaymodular assayvalidation

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Area of Science:

  • Immunology
  • Biotechnology
  • Clinical Trials

Background:

  • High-parameter flow cytometry (hpFCM) is crucial for immune profiling and biomarker discovery in clinical trials.
  • Clinical adoption is limited by assay variability, logistical issues, and complexity, necessitating robust quality controls and validation.

Purpose of the Study:

  • To introduce and validate a modular hpFCM approach for flexible and reproducible immune cell analysis in drug development.
  • To enable dynamic customization of assays throughout clinical studies for evolving immunophenotyping needs.

Main Methods:

  • Developed a modular hpFCM assay with a core panel and interchangeable marker modules.
  • Validated assay reliability, accuracy, selectivity, repeatability, and reproducibility according to CLSI H62 guidelines.
  • Assessed specimen stability for both whole blood and frozen peripheral blood mononuclear cells (PBMCs).

Main Results:

  • The modular hpFCM assay demonstrated high accuracy, selectivity, repeatability, and reproducibility across configurations.
  • Key secondary endpoints (e.g., CD8+ T cells) showed precision (<20% CV), with specimen stability up to 4 days.
  • Exploratory endpoints showed 90% repeatability and 55% stability over 4 days.

Conclusions:

  • The modular hpFCM approach offers a scalable, agile, and cost-effective framework for biomarker strategies in drug development.
  • This adaptable design addresses limitations in current hpFCM workflows, enhancing operational efficiency and enabling reverse translational research.
  • The framework facilitates dynamic immunophenotyping and biomarker discovery, streamlining clinical implementation, though further validation in real-world trials is ongoing.