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Article CommentaryCommentary

Risk-based Process Development of Biosimilars as Part of the Quality by Design Paradigm

Dénes Zalai, Christian Dietzsch and Christoph Herwig
PDA Journal of Pharmaceutical Science and Technology November 2013, 67 (6) 569-580; DOI: https://doi.org/10.5731/pdajpst.2013.00943
Dénes Zalai
1Gedeon Richter Plc., Department of Biotechnology, Budapest, Hungary; and
2Vienna University of Technology, Institute of Chemical Engineering, Research Area Biochemical Engineering, Vienna, Austria
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Christian Dietzsch
2Vienna University of Technology, Institute of Chemical Engineering, Research Area Biochemical Engineering, Vienna, Austria
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Christoph Herwig
2Vienna University of Technology, Institute of Chemical Engineering, Research Area Biochemical Engineering, Vienna, Austria
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  • For correspondence: christoph.herwig@tuwien.ac.at zalaid@richter.hu christian.dietzsch@tuwien.ac.at christoph.herwig@tuwien.ac.at
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Article Information

vol. 67 no. 6 569-580
DOI 
https://doi.org/10.5731/pdajpst.2013.00943
PubMed 
24265299

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online November 21, 2013.

Copyright & Usage 
© PDA, Inc. 2013

Author Information

  1. Dénes Zalai1,2,
  2. Christian Dietzsch2 and
  3. Christoph Herwig2,*
  1. 1Gedeon Richter Plc., Department of Biotechnology, Budapest, Hungary; and
  2. 2Vienna University of Technology, Institute of Chemical Engineering, Research Area Biochemical Engineering, Vienna, Austria
  1. ↵*Corresponding Author: Christoph Herwig, Vienna University of Technology, Institute of Chemical Engineering, Research Area Biochemical Engineering, Gumpendorfer Strasse 1a, A-1060 Vienna, Austria. Tel: +43 1 58801 166400, Fax: +43 1 58801 166980, email: christoph.herwig@tuwien.ac.at; E-mail addresses: zalaid@richter.hu, christian.dietzsch@tuwien.ac.at, christoph.herwig@tuwien.ac.at
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PDA Journal of Pharmaceutical Science and Technology: 67 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 67, Issue 6
November/December 2013
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Risk-based Process Development of Biosimilars as Part of the Quality by Design Paradigm
Dénes Zalai, Christian Dietzsch, Christoph Herwig
PDA Journal of Pharmaceutical Science and Technology Nov 2013, 67 (6) 569-580; DOI: 10.5731/pdajpst.2013.00943
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    • Abstract
    • Introduction
    • Positioning Risk Assessments in the QbD Workflow
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  • Quality by Design

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Risk-based Process Development of Biosimilars as Part of the Quality by Design Paradigm
Dénes Zalai, Christian Dietzsch, Christoph Herwig
PDA Journal of Pharmaceutical Science and Technology Nov 2013, 67 (6) 569-580; DOI: 10.5731/pdajpst.2013.00943

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