21. Integrated Process Design: Characterization of Process and Product Definition of Design Spaces

  1. Dr. Ganapathy Subramanian
  1. Richard Francis

Published Online: 15 OCT 2012

DOI: 10.1002/9783527653096.ch21

Biopharmaceutical Production Technology, Volume 1 & Volume 2

Biopharmaceutical Production Technology, Volume 1 & Volume 2

How to Cite

Francis, R. (2012) Integrated Process Design: Characterization of Process and Product Definition of Design Spaces, in Biopharmaceutical Production Technology, Volume 1 & Volume 2 (ed G. Subramanian), Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim, Germany. doi: 10.1002/9783527653096.ch21

Editor Information

  1. 44 Oaken Grove, Maidenhead, Berkshire SL6 6HH, United Kingdom

Author Information

  1. Francis Pharma, 38 Longmeadow, Riverhead, Kent TN13 2QY, UK

Publication History

  1. Published Online: 15 OCT 2012
  2. Published Print: 18 JUL 2012

ISBN Information

Print ISBN: 9783527330294

Online ISBN: 9783527653096

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Keywords:

  • biopharmaceutical;
  • integrated process design;
  • design spaces;
  • quality by design;
  • target product profile;
  • critical quality attribute;
  • safety

Summary

This chapter contains sections titled:

  • Introductory Principles

  • Original Process Development Paradigm

  • The Essential QbD Concepts

  • Conclusion

  • References