INTACT Mass™ - A Versatile waters_connect™ Application For Rapid Mass Confirmation And Purity Assessment Of Biotherapeutics

By Henry Shion, Patrick Boyce, Scott J. Berger, Ying Qing Yu, Waters Corporation

Intact mass analysis can provide a global profile of biotherapeutics, confirming predicted mass, profiling product heterogeneity, and assigning impurities. In recent years, LC-MS intact mass analysis has become an indispensable tool for attribute characterization and attribute monitoring of biotherapeutics across all stages of their development and commercialization. Functions such as discovery screening, process development, and formulations/stability can generate a large number of samples, and analytical solutions that can achieve highthroughput intact mass analysis and impurity profiling are advantageous to matching these requirements.

Here, we report the development of a waters_connect application that streamlines LC-MS data acquisition, data intact mass processing and reporting of results suitable for a compliance-ready environment. The INTACT Mass Application can be applied for simple mass confirmation, high-throughput intact mass screening, and product impurity profiling. In this application note, the key stages of the workflow for high throughput targeted mass confirmation will be demonstrated. Experimental results obtained from six commercial monoclonal antibodies (mAbs), and NISTmAb IdeS digested subunits will be discussed.