Orthogonal tools to help determine the required selectivity of ligand-binding assays in drug development

“Complex large molecules would have various requirements for selectivity dependent on the biological matrix, the analyte’s chemical and biological nature, and the study intent.” Ligand-binding assays (LBAs) are commonly applied to large molecule (LM) bioanalysis to support PK and PD studies during drug development. Specificity/selectivity is an important characteristic that must be evaluated and established. The terms ‘specificity’ and ‘selectivity’ are often used interchangeably, although specificity generally relates to the physicochemical structure of the analyte. Specificity of a LBA is mainly dependent on the special binding reagents [1] and was defined as the ability of the reagents to bind to...