Skip to main content
U.S. flag

An official website of the United States government

Official websites use .gov
A .gov website belongs to an official government organization in the United States.

Secure .gov websites use HTTPS
A lock ( ) or https:// means you’ve safely connected to the .gov website. Share sensitive information only on official, secure websites.

Structural Elucidation of Chemical and Post-translational Modifications of Monoclonal Antibodies

Published

Author(s)

Wenzhou Li, James L. Kerwin, John E. Schiel, Catherine A. Mouchahoir, Darryl Davis, Andrew Mahan, Sabrina A. Benchaar

Abstract

Therapeutic monoclonal antibodies (mAbs), a rapidly growing class of therapeutic drugs, present a daunting challenge for structural characterization. They are heterodimers of separate light and heavy chains comprising over 1200 amino acid residues. During cellular production as well as during processing and storage, the primary amino acid sequence may be modified through post-translational or chemical processes, and these modifications can affect biological activity, half-life and immunogenicity. Beginning with basic research and proceeding through the various steps of production and formulation, post-translational and chemical modifications (PTMs) must be discovered, tracked, and evaluated for quality, safety, and efficacy. A brief review of the more common modifications encountered during development is presented, with emphasis on those identified on the reference mAb provided by the National Institute of Standards and Technology (NIST). Current and future promising approaches utilizing mass spectrometric and complementary techniques for structural characterization of mAbs are discussed. Many of the aforementioned techniques were used in the characterization of the NIST mAb Reference Material, the results of which are summarized in this chapter.
Citation
Current, State of the Art, and Emerging Technologies for the Analysis of Monoclonal Antibodies
Publisher Info
ACS Publications, Washington, DC

Keywords

NIST mAb, biopharmaceutical characterization, monoclonal antibody, post-translational modification, peptide mapping, forced degradation

Citation

Li, W. , Kerwin, J. , Schiel, J. , Mouchahoir, C. , Davis, D. , Mahan, A. and Benchaar, S. (2015), Structural Elucidation of Chemical and Post-translational Modifications of Monoclonal Antibodies, ACS Publications, Washington, DC, [online], https://doi.org/10.1021/bk-2015-1201.ch003 (Accessed June 19, 2024)

Issues

If you have any questions about this publication or are having problems accessing it, please contact reflib@nist.gov.

Created October 14, 2015, Updated October 12, 2021