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The role of mass spectrometry in the characterization of biologic protein products



Deepali Rathore, John E. Schiel, Anneliese Faustino, Eric Pang, Michael Boyne, Sarah M. Rogstad


Introduction: Mass spectrometry (MS) is widely used in the characterization of biomolecules including peptide and protein therapeutics. These biotechnology products have seen rapid growth over the past few decades and continue to dominate the global pharmaceutical market. Advances in MS instrumentation and techniques have enhanced protein characterization capabilities and supported an increased development of biopharmaceutical products. Areas covered: This review describes recent developments in MS-based biotherapeutic analysis including sequence determination, post-translational modifications (PTMs) and higher order structure (HOS) analysis along with improvements in ionization and dissociation methods. An outlook of emerging applications of MS in the lifecycle of product development such as comparability, biosimilarity and quality control practices is also presented. Expert commentary: MS-based methods have established their utility in the analysis of new biotechnology products and their lifecycle appropriate implementation. In the future, MS will likely continue to grow as one of the leading protein identification and characterization techniques in the biopharmaceutical industry landscape.
Expert Review of Proteomics


Biotechnology products, mass spectrometry, monoclonal antibodies, protein therapeutics


Rathore, D. , Schiel, J. , Faustino, A. , Pang, E. , Boyne, M. and Rogstad, S. (2018), The role of mass spectrometry in the characterization of biologic protein products, Expert Review of Proteomics, [online], (Accessed February 21, 2024)
Created April 24, 2018, Updated October 12, 2021