Chapter 9. Application of Quality by Design and Risk Assessment Principles for the Development of Formulation Design Space

  1. Anurag S. Rathore2,
  2. Rohin Mhatre3
  1. Kingman Ng,
  2. Natarajan Rajagopalan

Published Online: 28 OCT 2008

DOI: 10.1002/9780470466315.ch9

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

Ng, K. and Rajagopalan, N. (2008) Application of Quality by Design and Risk Assessment Principles for the Development of Formulation 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.ch9

Editor Information

  1. 2

    Amgen Inc., Thousand Oaks, California, USA

  2. 3

    Biogen Idec, Cambridge, Massachusetts, USA

Author Information

  1. Eli Lilly and Company, Indianapolis, Indiana, 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) approach;
  • molecular degradation characterization;
  • design and risk assessment quality application

Summary

This chapter contains sections titled:

  • Introduction

  • Quality by Design (QbD) Approach

  • Target Product Profile (TPP)

  • Molecular Degradation Characterization

  • Active Pharmaceutical Ingredient (API) Critical Properties

  • Preformulation Characterization

  • Initial Formulation Risk Assessments

  • Formulation Optimization and Design Space

  • Selection of Solution Formulation Composition

  • Summary

  • Acknowledgments

  • References

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