Application Note

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

Source: Waters Corporation

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

GettyImages-1074985438-molecule

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.

VIEW THE APPLICATION NOTE!

Get unlimited access to:

Trend and Thought Leadership Articles
Case Studies & White Papers
Extensive Product Database
Members-Only Premium Content
Welcome Back! Please Log In to Continue. X

Enter your credentials below to log in. Not yet a member of Clinical Leader? Subscribe today.

Subscribe to Clinical Leader X

Please enter your email address and create a password to access the full content, Or log in to your account to continue.

or

Subscribe to Clinical Leader