12. Characterization of Impurities and Degradants in Protein Therapeutics by Mass Spectrometry

  1. Birendra N. Pramanik2,
  2. Mike S. Lee3 and
  3. Guodong Chen4
  1. Li Tao,
  2. Michael Ackerman,
  3. Wei Wu,
  4. Peiran Liu and
  5. Reb Russell

Published Online: 12 JUL 2011

DOI: 10.1002/9780470921371.ch12

Characterization of Impurities and Degradants Using Mass Spectrometry

Characterization of Impurities and Degradants Using Mass Spectrometry

How to Cite

Tao, L., Ackerman, M., Wu, W., Liu, P. and Russell, R. (2011) Characterization of Impurities and Degradants in Protein Therapeutics by Mass Spectrometry, in Characterization of Impurities and Degradants Using Mass Spectrometry (eds B. N. Pramanik, M. S. Lee and G. Chen), John Wiley & Sons, Inc., Hoboken, NJ, USA. doi: 10.1002/9780470921371.ch12

Editor Information

  1. 2

    Merck and Co., Kenilworth, NJ, USA

  2. 3

    Milestone Development Services, Newtown, PA, USA

  3. 4

    Bristol-Myers Squibb Company, Princeton, NJ, USA

Author Information

  1. Bristol-Myers Squibb Co., 311 Pennington-Rocky Hill Road, Pennington, NJ 08534, USA

Publication History

  1. Published Online: 12 JUL 2011
  2. Published Print: 16 MAY 2011

Book Series:

  1. Wiley Series on Pharmaceutical Science and Biotechnology: Practices, Applications, and Methods

Book Series Editors:

  1. Mike S. Lee

Series Editor Information

  1. Milestone Development Services, Newtown, PA, USA

ISBN Information

Print ISBN: 9780470386187

Online ISBN: 9780470921371

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Keywords:

  • impurity and degradant characterization - in protein therapeutics by mass spectrometry - protein-based drugs, therapeutic targets;
  • characterization and quantitative analysis of oxidation - role in biopharmaceutical development;
  • MS pivotal role, in biomolecule understanding - component monitoring, biomolecules produced reproducibly, with variant amount

Summary

This chapter contains sections titled:

  • Introduction to Therapeutic Proteins

  • Recent Advances in Mass Spectrometry

  • Impurities

  • Degradation Products

  • Conclusions

  • References