Chapter 1. Quality by Design: An Overview of the Basic Concepts

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

Published Online: 28 OCT 2008

DOI: 10.1002/9780470466315.ch1

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

Mhatre, R. and Rathore, A. S. (2008) Quality by Design: An Overview of the Basic Concepts, 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.ch1

Editor Information

  1. 1

    Amgen Inc., Thousand Oaks, California, USA

  2. 2

    Biogen Idec, Cambridge, Massachusetts, USA

Author Information

  1. 1

    Amgen Inc., Thousand Oaks, California, USA

  2. 2

    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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CHAPTER TOOLS

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Keywords:

  • Quality by Design (QbD) and mechanism of action (MOA) and molecule safety;
  • molecule critical quality attribute (CQA) understanding;
  • process analytical technology (PAT) and QbD

Summary

This chapter contains sections titled:

  • Introduction

  • Critical Quality Attributes

  • An Overview of Design Space

  • Raw Materials and their Impact on QbD

  • Process Analytical Technology

  • The Utility of Design Space and QbD

  • Conclusions

  • References

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