17. Systematic Approach to Optimization and Comparability of Biopharmaceutical Glycosylation Throughout the Drug Life Cycle

  1. Dr. Ganapathy Subramanian
  1. Daryl L. Fernandes

Published Online: 15 OCT 2012

DOI: 10.1002/9783527653096.ch17

Biopharmaceutical Production Technology, Volume 1 & Volume 2

Biopharmaceutical Production Technology, Volume 1 & Volume 2

How to Cite

Fernandes, D. L. (2012) Systematic Approach to Optimization and Comparability of Biopharmaceutical Glycosylation Throughout the Drug Life Cycle, in Biopharmaceutical Production Technology, Volume 1 & Volume 2 (ed G. Subramanian), Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim, Germany. doi: 10.1002/9783527653096.ch17

Editor Information

  1. 44 Oaken Grove, Maidenhead, Berkshire SL6 6HH, United Kingdom

Author Information

  1. Ludger Ltd, Culham Science Centre, Abingdon OX14 3EB, UK

Publication History

  1. Published Online: 15 OCT 2012
  2. Published Print: 18 JUL 2012

ISBN Information

Print ISBN: 9783527330294

Online ISBN: 9783527653096

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Keywords:

  • biopharmaceutical;
  • glycosylation;
  • quality by design;
  • modeling;
  • comparability;
  • critical quality attribute

Summary

This chapter contains sections titled:

  • Costs of Inconsistent, Unoptimized Drug Glycosylation

  • Scheme 1: Traditional Approach to Comparability of Drug Glycosylation

  • Scheme 2: Comparability of Drug Glycosylation Using QbD DS

  • Scheme 3: Enhanced QbD Approach to Comparability of Drug Glycosylation

  • Conclusions

  • Acknowledgments

  • References