12. Pat Tools for Biologics: Considerations and Challenges

  1. Anurag S. Rathore3 and
  2. Rohin Mhatre4
  1. Michael Molony1 and
  2. Cenk Undey2

Published Online: 28 OCT 2008

DOI: 10.1002/9780470466315.ch12

Quality by Design for Biopharmaceuticals: Principles and Case Studies

Quality by Design for Biopharmaceuticals: Principles and Case Studies

How to Cite

Molony, M. and Undey, C. (2008) Pat Tools for Biologics: Considerations and Challenges, 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.ch12

Editor Information

  1. 3

    Amgen Inc., Thousand Oaks, California, USA

  2. 4

    Biogen Idec, Cambridge, Massachusetts, USA

Author Information

  1. 1

    Allergan Corporation, Irvine, California, USA

  2. 2

    Amgen Inc., West Greenwich, Rhode Island, 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:

  • process analytical technology (PAT) tools for biologics - considerations and challenges;
  • cell culture and fermentation PAT tools;
  • chemometrics and advanced process control tools

Summary

This chapter contains sections titled:

  • Introduction

  • Cell Culture and Fermentation PAT Tools

  • Purification PAT Tools

  • Formulation PAT Tools

  • PAT Tools for Bioprocess Starting Materials, Defined Media, and Complex Raw Materials

  • Chemometrics and Advanced Process Control Tools

  • The power of PLS and PCA

  • “Relevant Time” Column Integrity Monitoring (Moments Analysis versus HETP)

  • Challenges for Implementation of PAT Tools

  • Future PAT Tools

  • Acknowledgments

  • References