10. Application of QbD Principles to Biologics Product: Formulation and Process Development

  1. Anurag S. Rathore3 and
  2. Rohin Mhatre4
  1. Satish K. Singh1,
  2. Carol F. Kirchhoff2 and
  3. Amit Banerjee2

Published Online: 28 OCT 2008

DOI: 10.1002/9780470466315.ch10

Quality by Design for Biopharmaceuticals: Principles and Case Studies

Quality by Design for Biopharmaceuticals: Principles and Case Studies

How to Cite

Singh, S. K., Kirchhoff, C. F. and Banerjee, A. (2009) Application of QbD Principles to Biologics Product: Formulation and Process Development, 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.ch10

Editor Information

  1. 3

    Amgen Inc., Thousand Oaks, California, USA

  2. 4

    Biogen Idec, Cambridge, Massachusetts, USA

Author Information

  1. 1

    Pfizer Inc., Chesterfield, Missouri, USA

  2. 2

    Pfizer Corporation, Chesterfield, Missouri, 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:

  • QbD in biologics product development;
  • ranking quality attributes (QA) and parameters;
  • experimental design for product composition robustness

Summary

This chapter contains sections titled:

  • Introduction: QbD in Biologics Product Development

  • Risk Assessment Process

  • Examples

  • Conclusions

  • References