BioAccord LC-MS System Performance Evaluation

This document is an application note that evaluates the performance of the Waters BioAccord LC-MS system for intact mass analysis in biopharmaceutical applications. It focuses on the system's reproducibility for monoclonal antibody (mAb) glycoprofiling, addressing the challenges of inter- and intra-system variability in mass spectrometry. The study outlines a two-part evaluation, with the first part dedicated to intact mass analysis. The results indicate that the BioAccord system demonstrates excellent reproducibility, with a relative standard deviation (%RSD) of less than 2% for continuous operation over 5.5 days and less than 6% for intra-system comparisons across six different systems. The document details the experimental setup, including the use of specific reagents and conditions for analysis, and concludes that the BioAccord system is suitable for routine biopharmaceutical analysis in both regulated and non-regulated environments. This application note serves to inform users about the capabilities and reliability of the BioAccord system in late-stage development and quality control laboratories.