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Manufacture Small Molecules

Fixing the Negative Perception of QbD

Quality by design (QbD), which has been with us for decades, is defined by the International Society for Pharmaceutical Engineering (ISPE) as a “systematic approach to development that begins with predefined objectives and emphasizes product and process understanding based on sound science and quality risk management”. The main principles have been assembled by the International Conference on Harmonization (ICH), as laid down in well-known guidelines.

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About the Author

Christoph Herwig

With a degree in process engineering, Christoph Herwig started his career by building continuously operational chemical facilities, but soon realized that it would be higher-value-added products that would secure success. Following a PhD at the ETH Lausanne to develop bioprocesses using novel quantification tools, he made the move back to industry where he worked mainly as a translator between mathematicians, biologists and engineers. Since 2008, he has been professor of biochemical engineering at the Vienna University of Technology. At the university’s Christian Doppler Laboratory, he focuses on the mission of building safe bioproducts using quality by design principles.

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