2. Considerations for Biotechnology Product Quality by Design

  1. Anurag S. Rathore2 and
  2. Rohin Mhatre3
  1. Steven Kozlowski and
  2. Patrick Swann

Published Online: 28 OCT 2008

DOI: 10.1002/9780470466315.ch2

Quality by Design for Biopharmaceuticals: Principles and Case Studies

Quality by Design for Biopharmaceuticals: Principles and Case Studies

How to Cite

Kozlowski, S. and Swann, P. (2009) Considerations for Biotechnology Product Quality by Design, 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.ch2

Editor Information

  1. 2

    Amgen Inc., Thousand Oaks, California, USA

  2. 3

    Biogen Idec, Cambridge, Massachusetts, USA

Author Information

  1. Food and Drug Administration, Silver Spring, Maryland, 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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Keywords:

  • biotechnology product quality by design;
  • product quality characteristics and product-related impurities;
  • design space development

Summary

This chapter contains sections titled:

  • Introduction

  • Quality by Design

  • Relevant Product Attributes

  • Manufacturing Process

  • Developing a Design Space

  • Uncertainty and Complexity

  • Future Horizons

  • QbD Submission Thoughts

  • Implementation Plans

  • Summary

  • Acknowledgments

  • References