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Bioanalysis >> Biomarker Testing Services >> Flow Cytometry

Flow Cytometry

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Flow Cytometry Services

As a leading innovator in flow cytometry technologies and services, Eurofins Bioanalytical Services  understands the power of in-depth cell analysis for research and pharmaceutical development. With over 20 years of experience in flow cytometry custom assay development, assay validation, and sample processing, we offer you a sophisticated consultant and service solution for a wide variety of applications.

Qualified Flow Cytometry Immunophenotyping Assays for Use in Clinical Trials

TBNK panel for identification of several of the major leukocyte populations

T cells including the CD4 and CD8 subsets, B cells, NK cells, NKT cells lymphocytes and monocytes

T helper panel for the identification of several key functional T lymphocyte subsets

Th1, Th2, Th17), in both whole blood and cryopreserved PBMC.

T cells including the CD4 and CD8 subsets, B cells, NK cells, NKT cells lymphocytes and monocytes

Rapid-access assays: reduced cost, quick development time

Flexibility: ready to go or can be validated according to the levels required by the study

Eurofins Bioanalytical Services has experience running the following flow cytometry studies in both exploratory and regulated (GLP/GCP) studies

  • Immunophenotyping
  • Quantification of cell-bound drug/Ligand occupancy (saturation/modulation)
  • Phosphorylation of proteins
  • Intracellular antigens/cytokines
  • Cell proliferation
  • Toxicity
  • Antibody Dependent Cell-mediated Cytotoxicity (ADCC)
  • Cellular activation

Case Study

Assay Development and Validation of a Receptor Occupancy Assay Using Flow Cytometry

Situation →

Our Role →

Outcome
  • A global Pharma Company had a receptor occupancy assay as a primary endpoint in a multi-site Phase II studies
  • The assay in use required fresh whole blood samples, but was generating variable results at their CRO partner, partly due to long shipping times and no suitable QC procedure for samples at CRO
  • Re-developed and re-validated the assay utilizing frozen PBMC samples to be processed at clinical sites
  • Initiated a training program for research nurses and technicians in the procedure including theory, practical sessions, video, processing guide, certification and video conference support
  • Initiated a QC procedure to report the quality of samples based on viability and number of cells within data reporting, to enable the client to review anomalous data points
  • Supplied sample collection kits
  • Ensured good quality PBMC samples were received over a 2-year period from Russia, Europe, and US
  • Reported reliable and robust data which was successfully used to fit pharmacodynamic and pharmacokinetic dosing models
  • Eurofins Bioanalytical Services was selected as preferred supplier for these assays over a competitor, based on results

Downloads

Literature - Flow Cytometry

Eurofins Integrated Flow Cytometry

Eurofins Global Flow Cytometry Network

Qualified Flow Cytometry Flyer
Qualified Flow Cytometry Immunophenotyping Assays for Use in Clinical Trials

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Posters - Flow Cytometry

2024 18th WRIB Poster: Performance Qualification of BD FACS Symphony A5 Spectrally Enabled Instruments using Fluorescent Beads with National Institute of Standards and Technology (NIST) Assigned equivalent reference fluorophore (ERF)

Validating Flow Cytometry Assays for Use During Clinical Trial Biomarker Assessments

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Overcoming Challenges for Flow Cytometry in Clinical Regulated Biomarker Analysis

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