Chapter 8. Viral Clearance: A Strategy for Quality by Design and the Design Space

  1. Anurag S. Rathore3,
  2. Rohin Mhatre4
  1. Gail Sofer Consultant1,
  2. Jeffrey Carter2

Published Online: 28 OCT 2008

DOI: 10.1002/9780470466315.ch8

Book Title

Quality by Design for Biopharmaceuticals: Principles and Case Studies

Quality by Design for Biopharmaceuticals: Principles and Case Studies

Additional Information

How to Cite

Sofer, G. and Carter, J. (2008) Viral Clearance: A Strategy for Quality by Design and the Design Space, 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.ch8

Editor Information

  1. 3

    Amgen Inc., Thousand Oaks, California, USA

  2. 4

    Biogen Idec, Cambridge, Massachusetts, USA

Author Information

  1. 1

    SofeWare Associates, Austin, Texas, USA

  2. 2

    GE Healthcare, Westborough, Massachusetts, USA

Publication History

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

ISBN Information

Print ISBN: 9780470282335

Online ISBN: 9780470466315

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CHAPTER TOOLS

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Keywords:

  • viral clearance - strategy for quality;
  • QbD approach and critical quality attributes (CQAs);
  • virus clearance design space development

Summary

This chapter contains sections titled:

  • Introduction

  • Current and Future Approaches to Virus Clearance Characterization

  • Benefits of Applying Design Space Principles to Virus Clearance

  • Technical Limitations Related to Adoption of QbD/Design Space Concepts in Virus Clearance

  • Developing a Virus Clearance Design Space

  • Staying in the Design Space

  • Conclusion

  • Acknowledgments

  • References

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