Controlling The Risk Associated With Poor Analyte Recovery And Lack Of Assay Robustness

By Nilini Ranbaduge, Robert E. Birdsall, Ying Qing Yu, Weibin Chen

Peptide MAM is an LC-MS based assay for direct biotherapeutic product attribute analysis that is increasingly used in protein biotherapeutic quality assessment. As part of lifecycle management, assays need to remain accurate and consistent to ensure continued drug product quality and safety. In this respect, robust system performance plays a critical role in MAM data quality. Non-specific adsorption of acidic peptides to metal surfaces is a well-known phenomenon affecting LC-MS analyses, causing asymmetric peaks, loss of peptides, and increased variability in detector response for quantitative measurements. This work demonstrates the performance gains of the BioAccord configured with the inert ACQUITY Premier resulting in increased peptide recovery and robust MS response, with more reproducible results for attributes spanning 3-orders of magnitude in dynamic range. The improved performance from MaxPeak High Performance Surfaces (HPS) Technology demonstrates that the BioAccord System with ACQUITY Premier controlled by the compliant-ready waters_connect informatics is optimally suited as a LC-MS platform for MAM-based assays.