Challenges and Strategies for the Bioanalysis of Protein Therapeutics and Biomarkers by LC–MS/MS hosted by BioAgilytix

Bioanalysis of proteins by LC–MS/MS is a well-established technique in drug discovery and development. LC–MS/MS has gained popularity as a complementary approach to ligand-binding assays (LBA) and offers advantages over LBA in terms of critical reagents, specificity, multiplexing and reduced development time. Overall, LC–MS/MS-based bioanalysis of proteins continues to advance, driven by ongoing developments in instrumentation, sample preparation techniques and data analysis strategies. These advancements enhance the capabilities of researchers and regulatory authorities to assess the safety, efficacy and quality of protein-based drugs.

In this presentation, we will discuss the challenges we have encountered when developing LC–MS methods for protein therapeutics and biomarkers, as well as strategies to overcome such challenges. The presentation will focus on immunocapture condition optimization, signature peptide selection, digestion designs to obtain suitable signature peptides for quantification and stable isotope-labeled internal standard selection.

This webinar will provide a primer on the role of mass spectrometry in protein therapeutics bioanalysis with an emphasis on hybrid IA-LC-MS/MS workflow. Case studies on PK analysis as well as biomarker analysis will be presented to illustrate the challenges and the solutions. Affinity capture followed by enzymatic digestion is the general workflow for large molecule LC–MS bioanalysis.