Immunoanalysis: From Development To Routine Use

Thanks to more than two decades of track record in biomarker assay kit development & supply (>100 kits) and multi-disciplinary teams to select the most appropriate assay according to current guidelines.

Biomarker Quantification in body fluids & tissues

Bertin Pharma’s expertise related to Biomarker quantification in body fluids & tissues to support drug development includes:

  • fit-to-purpose development assay (sampling, pre-treatment, assay design & format)
  • update & validation of biomarker assays
  • bio-analysis to support translational research, pre-clinical assessment & clinical trial (Central Lab)
  • capabilities to provide ready-to-use & customized Assay Kit for in-house or central labs implementation
  • integrated service for tools development to worldwide supply chain
  • two GLP-certified facilities

Several types & selection of Assay formats

  • definitive quantitative assay: well-defined standard fit to a regression model to calculate the absolute quantitative values (steroïds)
  • relative quantitative assay: response-concentration calibration function. Standard may not be fully characterized or fully representative of an endogenous biomarker (cytokines)
  • quasi-quantitative assay: does not use a calibration standard but has a continuous response (antibody titers of antidrug antibody)
  • qualitative assay lack proportionality to the amount of analyte in a sample. Such data may be nominal (as the presence or absence of a gene or gene product) or ordinal with discrete scoring scales (immunohistochemical assays).

Our ImmunoAnalytical Specificities