Biomarker Quantitation: Analytical Considerations for Ligand Binding Assay Regression Curves and Quality Control Samples

Abstract

As biomarkers grow in relevance for both the design and support of therapeutics and the clinical trials associated with them, there is an ever increasing need for accurate quantitation of these biochemical entities in biological matrices. While quantifying many biotherapeutics via ligand binding assay platforms can be fairly straightforward, biomarkers present some unique challenges that must be taken into account during assay development, validation and subsequent sample analysis. These challenges can be especially confounded by the relationship between two ligand binding assay tools: The regression curve and quality control samples. Due diligence must be performed to develop an assay that takes into account matrix vs. buffer effects and endogenous biomarker presence. Lack of diligence in these areas can lead to less than reliable results, thus potentially rendering the intended use of the assay moot.