Cellular Biomarker Analysis Services
For cellular biomarkers, we bring a comprehensive suite of cellular assay capabilities under one roof – integrating flow cytometry and cell-based analyses to generate high-quality data that guide confident development decisions.
What are cellular biomarkers?
Biomarkers can be categorized as either soluble or cellular.
Cellular biomarkers refer to the measurement of events within or on the surface of cells. Examples include cell surface markers (e.g., CD antigens), intracellular signaling molecules, and functional properties such as cytotoxic activity or proliferation state.
What is the cellular biomarker strategy?
Sample Matrix
Whole blood, PBMCs, tissue biopsies
Assay Development Time
Moderate; multiplexing possible pending the technology selected
Quantitation
Can be qualitative or semi-quantitative with integration of quantitation beads (flow cytometry)
Regulatory Path
More complex than for soluble biomarkers; evolving requirements for flow cytometry
Challenges
Cell viability and stability, assay standardization
Validation Parameters
Accuracy, precision, LLOD/LLOQ, robustness (operator and instrument), stability
Technology and instrumentation for cellular biomarkers analysis
We offer one of the most comprehensive technology platforms for cellular biomarker testing, spanning flow cytometry and ELISpot assays.
Additional resources
Blogs
In the ever-evolving landscape of drug development, biomarkers have emerged as critical tools for the mechanism of action, early proof of mechanism, safety, predictive, efficacy, and monitoring treatment response. As the field advances, two major classes of biomarkers have come to the forefront: soluble biomarkers and cellular biomarkers. While…
Blogs
Biomarkers (BMKs) have become fundamental tools in drug development, accelerating and optimizing targeted therapeutic innovation. As a bioanalytical CRO with over 15 years of experience in biomarker analysis, we’ve seen firsthand how the strategic integration of biomarkers can accelerate drug programs, help meet evolving regulatory standards,…
Blogs
Initially developed to assess the frequency of circulating antigen-specific Antibody-Secreting Cells (ASC), ELISpot has become a vital tool for quantifying antigen-reactive T-cells by measuring secreted immune mediators such as cytokines or key molecules involved in cell-mediated cytotoxicity. Compared to other assays for monitoring cell-mediated immunity (CMI), such as…
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