5. Case Study on Definition of Process Design Space for a Microbial Fermentation Step

  1. Anurag S. Rathore1 and
  2. Rohin Mhatre2
  1. Pim van Hoek,
  2. Jean Harms,
  3. Xiangyang Wang and
  4. Anurag S. Rathore

Published Online: 28 OCT 2008

DOI: 10.1002/9780470466315.ch5

Quality by Design for Biopharmaceuticals: Principles and Case Studies

Quality by Design for Biopharmaceuticals: Principles and Case Studies

How to Cite

van Hoek, P., Harms, J., Wang, X. and Rathore, A. S. (2009) Case Study on Definition of Process Design Space for a Microbial Fermentation Step, 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.ch5

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:

  • concept of “design space” in biotech community;
  • FMEA risk assessment tool in biotech industry for underlying rigorous methodology;
  • characterization ranges (CRs) and normal operating range (NOR)

Summary

This chapter contains sections titled:

  • Introduction

  • Approach Toward Process Characterization

  • Risk Analysis

  • Small-Scale Model Development and Qualification

  • Design of Experiment Studies

  • Worst Case Studies

  • Definition of Design Space

  • Definition of Validation Acceptance Limits

  • Regulatory Filing, Process Monitoring, and Postapproval Changes

  • Acknowledgment

  • References