13. Evolution and Integration of Quality by Design and Process Analytical Technology

  1. Anurag S. Rathore1 and
  2. Rohin Mhatre2
  1. Duncan Low and
  2. Joseph Phillips

Published Online: 28 OCT 2008

DOI: 10.1002/9780470466315.ch13

Quality by Design for Biopharmaceuticals: Principles and Case Studies

Quality by Design for Biopharmaceuticals: Principles and Case Studies

How to Cite

Low, D. and Phillips, J. (2008) Evolution and Integration of Quality by Design and Process Analytical Technology, 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.ch13

Editor Information

  1. 1

    Amgen Inc., Thousand Oaks, California, USA

  2. 2

    Biogen Idec, Cambridge, Massachusetts, USA

Author Information

  1. Amgen Inc., Thousand Oaks, California, 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:

  • evolution and integration of quality by design and process;
  • QbD and PAT implementation;
  • chromatography - critical purification tool in biotechnology

Summary

This chapter contains sections titled:

  • Introduction

  • Evolution of PAT and Quality by Design (QbD): Emerging Guidelines and Standards

  • Process Analytical Technology (PAT)

  • Quality by Design

  • Implementing QbD and PAT

  • Conclusions

  • Acknowledgments

  • References