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Improvement of the Degradation Profiling of Eculizumab and Omalizumab Monoclonal Antibodies by Liquid Chromatography–Mass Spectrometry

Authors
  • Degterev, M.1
  • Smolov, M.1
  • Shukurov, R.1
  • 1 JSC “Generium”, Volginskiy, Vladimir oblast, 601125, Russia , Volginskiy (Russia)
Type
Published Article
Journal
Journal of Analytical Chemistry
Publisher
Pleiades Publishing
Publication Date
Dec 22, 2021
Volume
76
Issue
14
Pages
1596–1609
Identifiers
DOI: 10.1134/S1061934821140033
Source
Springer Nature
Keywords
Disciplines
  • Articles
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Abstract

AbstractThe control of the degradation of monoclonal antibodies is one of primary steps of the biologics development process. Traditionally a range of chromatographic and electrophoretic procedures is used for this purpose. However, the most comprehensive information about the degradation process can be obtained using a multiple attribute method (MAM) approach based on bottom-up liquid chromatography–tandem mass spectrometry (LC–MS/MS). We perform a comparative evaluation of the forced degradation of omalizumab and eculizumab monoclonal antibodies obtained by the bottom-up approach, isoelectric focusing, and high-performance liquid chromatography. An advantage of HPLC–MS/MS in terms of dynamic range, specificity, and flexibility in the evaluation of degraded protein forms was demonstrated. The results show that the developed bottom-up approach can be used in the studies of the degradation of monoclonal antibodies and the routine biopharmaceutical quality control.

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