10. Application of QbD Principles to Biologics Product: Formulation and Process Development

  1. Anurag S. Rathore3 and
  2. Rohin Mhatre4
  1. Satish K. Singh1,
  2. Carol F. Kirchhoff2 and
  3. Amit Banerjee2

Published Online: 28 OCT 2008

DOI: 10.1002/9780470466315.ch10

Quality by Design for Biopharmaceuticals: Principles and Case Studies

Quality by Design for Biopharmaceuticals: Principles and Case Studies

How to Cite

Singh, S. K., Kirchhoff, C. F. and Banerjee, A. (2009) Application of QbD Principles to Biologics Product: Formulation and Process Development, 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.ch10

Editor Information

  1. 3

    Amgen Inc., Thousand Oaks, California, USA

  2. 4

    Biogen Idec, Cambridge, Massachusetts, USA

Author Information

  1. 1

    Pfizer Inc., Chesterfield, Missouri, USA

  2. 2

    Pfizer Corporation, Chesterfield, Missouri, USA

Publication History

  1. Published Online: 28 OCT 2008
  2. Published Print: 8 JUN 2009

ISBN Information

Print ISBN: 9780470282335

Online ISBN: 9780470466315

SEARCH

Options for accessing this content:

  • If you have access to this content through a society membership, please first log in to your society website.
  • Login via other institutional login options http://onlinelibrary.wiley.com/login-options.
  • You can purchase online access to this Chapter for a 24-hour period (price varies by title)
    • If you already have a Wiley Online Library or Wiley InterScience user account: login above and proceed to purchase the article.
    • New Users: Please register, then proceed to purchase the article.

Login via OpenAthens

or

Search for your institution's name below to login via Shibboleth.

Please register to:

  • Save publications, articles and searches
  • Get email alerts
  • Get all the benefits mentioned below!

Register now >