13. Identification and Quantification of Degradants and Impurities in Antibodies

  1. Birendra N. Pramanik2,
  2. Mike S. Lee3 and
  3. Guodong Chen4
  1. David M. Hambly and
  2. Himanshu S. Gadgil

Published Online: 12 JUL 2011

DOI: 10.1002/9780470921371.ch13

Characterization of Impurities and Degradants Using Mass Spectrometry

Characterization of Impurities and Degradants Using Mass Spectrometry

How to Cite

Hambly, D. M. and Gadgil, H. S. (2011) Identification and Quantification of Degradants and Impurities in Antibodies, 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.ch13

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. Amgen, 1201 Amgen Court West, Seattle, WA 98119, 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

SEARCH

Keywords:

  • degradant and impurity identification and quantification in antibodies - effective human therapeutics, protein drug essential modality;
  • methods, identifying and quantitating degradations and impurities - combination of approaches in protein drug evaluation;
  • antibodies, five classes for component activation against antigens - techniques for antibody characterization

Summary

This chapter contains sections titled:

  • Introduction to Antibodies and Protein Drugs

  • Overview of Degradations and Impurities in Protein Drugs and Antibodies

  • Methods Used to Identify and Quantitate Degradations and Impurities

  • Conclusions

  • Appendix

  • References