Better, Faster Solutions for Biopharmaceutical Characterization


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New capabilities and workflows have been implemented to accelerate the characterization of biopharmaceuticals, specifically in the areas of Drug-to-Antibody Ratio (DAR) analysis and Host Cell Protein (HCP) identification. In this presentation, we illustrate the latest enablement to easily and accurately analyze and determine DAR values of antibody-drug conjugates. In addition, automation capabilities have been developed to streamline sample preparation, such as antibody reduction and deglycosylation. Together with Walkup interface, DAR analysis and reporting can be effortlessly accomplished in an automated fashion by a large number of users ranging from LC/MS novices to experts. In parallel, a workflow has been developed to identify and quantify low level HCPs using 2D-LC separation coupled to directed MS analysis. We illustrate that HCPs can be confidently identified using a MS1 profiling and iterative directed MS strategy to serve as a superior acquisition method relative to the traditional shotgun MS/MS approach. Moreover, the beneficial use of different fractionation strategies as a first dimension for HCP analysis using 2D-LC-MS will be presented.

Learning Outcome

You will learn how the combination of new software and sample prep approaches in a single LC/MS workflow will facilitate the comprehensive identification of biopharmaceutical drugs which enables the refinement of current biotherapeutic enrichment strategies.