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Pharma Newsletters >> Eurofins Pharma Services Newsletter 13 - March 2016 >> Biomarker analysis by flow cytometry

Biomarker analysis by flow cytometry – a powerful technique in clinical trials

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Silke Huber, PhD, Head of Immunoanalytics, Eurofins BioPharma Product Testing Munich,

The past decade has witnessed a remarkable increase in small and large molecules, especially therapeutic antibodies – a trend, which is predicted to continue. Cellular biomarkers are necessary in defining disease pathology, toxicological assessment and efficacy. Flow cytometry is a powerful cellular analysis technique, which has proved to be valuable in research and clinical trial environments to further drug development.

Eurofins is well positioned to assist clients with specialised flow cytometry assay development, validation, and sample analysis needs. Eurofins has developed five modular core assays that drug developers can use as they are or can modify with additional markers to meet the needs of the specific clinical investigation, including:

  • TBNK assay (T-cell, B-cell, NK-cell)
  • Leukocyte activation panel
  • FceRI / IgE basophil assay
  • T-Helper cell panel
  • Monocyte, dendritic cell panel

The rapid-access of the “off the shelf” qualified panels provide: reduced cost, quick development time and flexibility to be validated according to the levels required by the study.

Eurofins’ Immunoanalytics Department operates multiple flow cytometry Canto II systems. Due to special needs for human material of clinical trials, the team has developed a method to ensure equal results of one sample measured on two machines. This represents a perfect back-up system. Sample analysis is performed in compliance with G(C)LP.

As a leading innovator in flow cytometry supporting long-term clinical trials, Eurofins uses molecules of equivalent soluble fluorochrome beads to enable the standardisation of fluorescence intensity units irrespective of instrument and day of measurement. Eurofins is highly experienced in supporting worldwide clinical trials and handling various samples from numerous clinical centres. Training of clinical sites by flow cytometry experts ensures high quality samples.

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