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Capillary Electrophoresis–Mass Spectrometry (CE-MS) by Sheath–Flow Nanospray Interface and Its Use in Biopharmaceutical Applications

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Capillary Electrophoresis-Mass Spectrometry

Part of the book series: Methods in Molecular Biology ((MIMB,volume 2531))

Abstract

Both capillary electrophoresis (CE) and mass spectrometry (MS) technologies are powerful analytical tools that have been used extensively in the characterization of biologics in the biopharmaceutical industry. The direct coupling of CE with MS is an attractive approach, in that the high separation capability of CE and the ultrasensitive detection and accurate identification performance of MS can be combined to provide a powerful system for the analysis of complex analytes. In this chapter, we discuss the detailed procedure of carrying out CE-MS analysis using a nano sheath–flow interface and its applications including intact mass analysis of monoclonal antibodies and fusion proteins, and a biotransformation study of two Fc-FGF21 molecules in a single-dose pharmacokinetic mice study. Optimization processes, including the finetuning of CE conditions and MS parameters, are illustrated in this chapter, with focuses on method robustness and assay reproducibility.

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Acknowledgments

The authors would like to thank James QW Xia from CMP Scientific for critical review and technical support, Andy Gieschen from Agilent for technical support and discussions, and our Amgen colleagues, Marcus Soto for running the PK studies, Dwight Winters for purifying the constructs. Thanks to Brooke M. Rock, Josh T. Pearson, Yunan Wang, Chris Spahr, Steve Smith, and Todd Hager for discussions.

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Authors and Affiliations

  1. Pharmacokinetics and Drug Metabolism, Amgen Research, Amgen Inc., South San Francisco, CA, USA

    Mei Han, Richard Smith & Dan A. Rock

Authors
  1. Mei Han
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  2. Richard Smith
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  3. Dan A. Rock
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Corresponding author

Correspondence to Mei Han .

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Editors and Affiliations

  1. Aalen University, Aalen, Baden-Württemberg, Germany

    Christian Neusüß

  2. Aalen University, Aalen, Baden-Württemberg, Germany

    Kevin Jooß

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Han, M., Smith, R., Rock, D.A. (2022). Capillary Electrophoresis–Mass Spectrometry (CE-MS) by Sheath–Flow Nanospray Interface and Its Use in Biopharmaceutical Applications. In: Neusüß, C., Jooß, K. (eds) Capillary Electrophoresis-Mass Spectrometry . Methods in Molecular Biology, vol 2531. Humana, New York, NY. https://doi.org/10.1007/978-1-0716-2493-7_2

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  • DOI: https://doi.org/10.1007/978-1-0716-2493-7_2

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  • Publisher Name: Humana, New York, NY

  • Print ISBN: 978-1-0716-2492-0

  • Online ISBN: 978-1-0716-2493-7

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