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Quality-by-design for biotechnology-related pharmaceuticals.
Linköping University, Department of Physics, Chemistry and Biology, Biotechnology . Linköping University, The Institute of Technology.
Sandoz GmbH.
Boehringer Ingelheim Pharma GmbH & Co. KG.
Sandoz GmbH.
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2009 (English)In: Biotechnology journal, ISSN 1860-7314, Vol. 4, no 5, 600-9 p.Article in journal (Refereed) Published
Abstract [en]

The following article is a report from a workshop on Quality-by-Design (QbD) held at the 7th European Symposium on Biochemical Engineering Science (7 September 2008, Faro, Portugal).The aim of the workshop was to provide an update on the present status of using QbD in biotechnology-related applications in the pharmaceutical industry. The report summarizes the essential parts of the presentations and covers the industrial, academic, and regulatory aspects of QbD. It concludes with recommendations for further work and development.

Place, publisher, year, edition, pages
2009. Vol. 4, no 5, 600-9 p.
National Category
Engineering and Technology
URN: urn:nbn:se:liu:diva-18976DOI: 10.1002/biot.200800333PubMedID: 19418475OAI: diva2:222189
Available from: 2009-06-07 Created: 2009-06-07 Last updated: 2009-06-07

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Mandenius, Carl-Fredrik
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Biotechnology The Institute of Technology
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