Chapter 11. QbD for Raw Materials

  1. Anurag S. Rathore1,
  2. Rohin Mhatre2
  1. Maureen Lanan

Published Online: 28 OCT 2008

DOI: 10.1002/9780470466315.ch11

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

Lanan, M. (2008) QbD for Raw Materials, 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.ch11

Editor Information

  1. 1

    Amgen Inc., Thousand Oaks, California, USA

  2. 2

    Biogen Idec, Cambridge, Massachusetts, USA

Author Information

  1. Biogen Idec, Cambridge, 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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Keywords:

  • quality by design (QbD);
  • DOE tool for QbD in developmental stage of process;
  • QbD for raw materials

Summary

This chapter contains sections titled:

  • Introduction

  • Background

  • Current Practice for Raw Materials

  • QbD in Development

  • QbD in manufacturing

  • QbD for organizations

  • Tests Available

  • Conclusions and Future Prospects

  • Acknowledgments

  • References

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