Approaches to Analyzing Therapeutic Peptides and Proteins by LC-MS/MS

Our interest in analyzing peptides and proteins arises from the need, during preclinical and clinical studies, to quantify levels of protein and peptide drugs and their metabolites (the process of bioanalysis). To support the predicted increase in peptides and proteins undergoing such studies, we expect that the demand for immunological and LC-MS/MS bioanalytical methods to increase. We have been working for the last several years to develop bioanalytical methods for accurate, selective and sensitive quantification of peptide and protein therapeutics. Developing and validating LC-MS/MS methods for proteins and peptides can be challenging, and presents additional difficulties over conventional methods for small molecule therapeutics. This article draws on our personal experience and knowledge to discuss some of these difficulties, and how they are overcome by the bioanalytical teams at Covance Laboratories.