Solutions for success: LC–MS in the changing landscape of large molecule bioanalysis

The world of bioanalysis is experiencing a strong shift toward large molecules. Current state of the art biotherapeutic research presents a great diversity of modalities that translates into a variety of bioanalytical challenges and multiplicity of analytical platforms. Bioanalysis of biological drugs has conventionally utilized ligand-binding assay (LBA) platforms. However, the recent advancements in MS technology provide the scientists with the ability to successfully address sensitivity, robustness, and reproducibility challenges in performing bioanalysis of biologics.

While peptide therapeutics offered some significant challenges from the traditional small molecules, the complexity of developing a robust, sensitive bioanalytical method increased with the protein-based therapeutics and monoclonal antibodies. In addition, a number of alternative scaffold-based biotherapeutics, such as antibody–drug conjugates (ADCs) have been recently introduced.The complexity of the ADC structure requires the need for a multi-analyte approach to describe appropriate PK properties.

While early discovery support for ADCs may require a qualitative relative investigation of the drug to antibody ratio, the clinical development phase requires a quantitative assessment of the conjugated drug concentration. Both may be done by utilizing LC-MS technologies, but will require different types of equipment and analytical skill sets. In this webinar, we exhibited how AB SCIEX continues to retain a dominant position in the world of bioanalysis by highlighting our successful workflows for every facet of biologics bioanalysis.

Speaker

Gary Impey
Director, Pharma/CRO MS Business Unit
AB SCIEX

Gary received his Ph.D. in Analytical Chemistry from York University in Toronto, Canada in 1998 and quickly joined Apotex Pharmaceuticals where he worked in the analytical R&D department. His graduate work involved instrument design and development, which led him to join the team at AB SCIEX demonstrating key features and benefits of the various mass spec technologies to prospective customers. Currently, Gary is responsible for leading the Quantitative and Metabolism portion of the Pharmaceutical & CRO MS Business at AB SCIEX. Part of Gary’s role involves the application of MS technologies in all areas of the drug discovery and development process and helping to guide the product development cycle with strategies to bring better solutions to the marketplace.