Technology Digest: Free versus total analyte quantification using ligand-binding assays

Drug development is fundamentally supported by preclinical and clinical study data, which measure accurate quantitative biotherapeutic drug concentrations. The data generated by the bioanalytical laboratory demonstrates the relationship between drug exposure and circulating drug concentrations enabling pharmacokinetics (PK), pharmacodynamics (PD) and dosing to be characterized.
Measurement of the free (unbound) concentration of an antibody-based biotherapeutic is of importance to understand its pharmacologic effects such as PK, PD, efficacy, toxicity and the dose-response relationship. However, measurement of the free analyte concentration is complicated due to the multiple forms of free analyte and ligand-bound analyte that can exist, with an equilibrium between the different forms.

In this eBook, we explore how to measure free versus total analyte concentrations using ligand-binding assays.

This eBook includes:

  • TECHNOLOGY DIGEST: Free versus total analyte quantification using ligand-binding assays

  • PERSPECTIVE: Free analyte QC concept: a novel approach to prove correct quantification of free therapeutic protein drug/biomarker concentrations

  • EDITORIAL: Free versus total ligand-binding assays: points to consider in biotherapeutic drug development

  • APPLICATION NOTE: Accurate measurement of free analyte using Gyrolab® platform vs ELISA

 

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