Hybridizing LBA with LC-MS/MS: the new norm for biologics quantification.

Abstract

Over the past 20 years, protein and peptide drug development has advanced significantly, becoming a rapidly growing segment of the biotherapeutics market. It has generated treatments for a wide variety of diseases ranging from inflammatory disorders to cancer [1,2]. This expansion of biologics-based medicines has pushed drug manufacturers to adopt new bioanalytical and analytical approaches to quantify and characterize multiple modalities of protein-based therapeutics efficiently with particular focus on the highthroughput needs of early-stage PK studies. Ligand-binding assays (LBAs) are widely used for bioanalysis of small and large molecules, but these assays can be lengthy to develop and have limited selectivity and sensitivity. LC–MS/MS-based bioanalysis can offer important advantages over immunoassaybased techniques, but LC–MS/MS with large molecules introduces several challenges affecting throughput, operating expertise and ease of use.