Comprehensive PTM Characterization of the NIST MAB Reference Standard Using a HRMS Mass Spectrometry

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Jing Fang, Nilini Ranbaduge, Henry Shion, William Alley and Ying Qing Yu
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The NIST mAb 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 set 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 PTM characterization of the new NIST mAb reference standard (RM 8671).

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