Quality-by-Design for biotechnology-related pharmaceuticals

Quality-by-Design for biotechnology-related pharmaceuticals

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 applicati...

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Bibliographic Details
Published in:Biotechnology journal Vol. 4; no. 5; pp. 600 - 609
Main Authors: Mandenius, Carl-Fredrik, Graumann, Klaus, Schultz, Torsten W., Premstaller, Andreas, Olsson, Ing-Marie, Petiot, Emma, Clemens, Christoph, Welin, Mats
Format: Journal Article
Language:English
Published: Weinheim WILEY-VCH Verlag 01-05-2009
WILEY‐VCH Verlag
Wiley-VCH Verlag
Subjects:
Active pharmaceutical ingredients
Biopharmaceuticals
Biopharmaceutics - methods
Biopharmaceutics - standards
Bioreactors
Biotechnology - methods
Biotechnology - standards
Design space
Design-of-Experiments
Drug Industry - standards
Education
Fermentation
Models, Biological
On-line monitoring and control
Research Design - standards
TECHNOLOGY
TEKNIKVETENSKAP
Life Sciences
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Summary: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.
Bibliography:ArticleID:BIOT200800333
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ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
content type line 23
ISSN:1860-6768
1860-7314
1860-7314
DOI:10.1002/biot.200800333