4. Using a Risk Assessment Process to Determine Criticality of Product Quality Attributes

  1. Anurag S. Rathore2 and
  2. Rohin Mhatre3
  1. Mark A. Schenerman,
  2. Milton J. Axley,
  3. Cynthia N. Oliver,
  4. Kripa Ram and
  5. Gail F. Wasserman

Published Online: 28 OCT 2008

DOI: 10.1002/9780470466315.ch4

Quality by Design for Biopharmaceuticals: Principles and Case Studies

Quality by Design for Biopharmaceuticals: Principles and Case Studies

How to Cite

Schenerman, M. A., Axley, M. J., Oliver, C. N., Ram, K. and Wasserman, G. F. (2009) Using a Risk Assessment Process to Determine Criticality of Product Quality Attributes, in Quality by Design for Biopharmaceuticals: Principles and Case Studies (eds A. S. Rathore and R. Mhatre), John Wiley & Sons, Inc., Hoboken, NJ, USA. doi: 10.1002/9780470466315.ch4

Editor Information

  1. 2

    Amgen Inc., Thousand Oaks, California, USA

  2. 3

    Biogen Idec, Cambridge, Massachusetts, USA

Author Information

  1. MedImmune, Gaithersburg, Maryland, USA

Publication History

  1. Published Online: 28 OCT 2008
  2. Published Print: 8 JUN 2009

ISBN Information

Print ISBN: 9780470282335

Online ISBN: 9780470466315

SEARCH

Keywords:

  • determining quality attribute criticality for biotechnology-derived products;
  • using risk assessment process;
  • glycosylation criticality

Summary

This chapter contains sections titled:

  • Introduction

  • Examples of Criticality Determination

  • Conclusion

  • Acknowledgments

  • References