Quantitative Bioanalysis of Intact Large Molecules using Mass Spectrometry

Abstract

As biologic drugs become an increasing segment in the overall pharmaceutical market, it is important to develop accurate and reliable methods to analyze these drugs in biological matrices. With advancements in technology, biologics’ complex molecular structures can now be selectivity distinguished and quantified using high-resolution mass spectrometry and deconvolution software. Intact (top-down) mass spectrometric techniques have been established as alternative or complementary bioanalytical techniques for instances when ligand binding assays (LBAs) alone were not well suited, as it can provide additional structural information, in its pharmacologically active form.