3P-53 PDF
Comprehensive PTM Characterization of the NIST mAb Reference Standard using an IMS QTOF Mass Spectrometry
The NIST RM 8671 reference standard material can function as a common standard for the biopharmaceutical industry, analytical instrument/software companies, and regulators. RM 8671 can be used to evaluate and improve current analytical technologies and capabilities for determining the physicochemical and biophysical attributes of monoclonal antibodies. An exhaustive amount of characterization data has been collected from QTOF and Orbitrap mass spectrometers and published (ACS Book series: "State-of-the-Art and Emerging Technologies for Therapeutic Monoclonal Antibody Characterization"). In this study, we demonstrate the use of a new bench top IMS QTOF MS controlled by a workflow driven software for common PTMs characterization of the new NIST mAb reference standard (RM 8671).
The IMS QTOF MS system performance was bench marked using NIST RM 8671. PTM characterizations were performed using the following streamlined analytical workflows: 1) intact protein/sub unit analysis for MW determination and C-terminal lysine variant analysis, 2) RapiFluor-MS labeled N-linked glycan profiling, and 3) peptide mapping using a data independent acquisition method. The potential benefits of incorporating ion mobility separation into routine analytical workflows are also discussed.