Bioanalysis of protein-based therapeutics has historically used ligand binding immunoaffinity (LBA) approaches. However, recently LBA has been combined with Liquid Chromatography-Mass Spectrometry, resulting in the term hybrid (LBA)-LC-MS/MS techniques. Hybrid LC-MS/MS has successfully been applied to the bioanalysis of biotherapeutics and biomarkers. The basic concept of hybrid LC-MS/MS can be defined as combining LBA for the selective isolation/enrichment of the target analyte from the biomatrix and LC-MS for selective detection of the isolated analyte. In this article, we present a brief overview of How To develop a hybrid LBA-LC-MS/MS method for biotherapeutics and biomarkers with an emphasis on the general workflow and procedures.
KEYWORDS: Ligand Binding Immunoaffinity, Hybrid LBA-LC-MS/MS, Biotherapeutics, Biomarkers, Method Development.