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

Dénes Zalai; Christian Dietzsch; Christoph Herwig

doi:10.5731/pdajpst.2013.00943

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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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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.

Author Information

Dénes Zalai1,2,
Christian Dietzsch2 and
Christoph Herwig2,*

¹Gedeon Richter Plc., Department of Biotechnology, Budapest, Hungary; and
²Vienna University of Technology, Institute of Chemical Engineering, Research Area Biochemical Engineering, Vienna, Austria

↵*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{at}tuwien.ac.at; E-mail addresses: zalaid{at}richter.hu, christian.dietzsch{at}tuwien.ac.at, christoph.herwig{at}tuwien.ac.at

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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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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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