SUBJECT
Analysis of Protein-Based Drugs
lecture
Master
2
Semester 1/3
Autumn semester
The purpose of the course is to provide a comprehensive knowledge about the complex physico-chemical and biological characterization of protein pharmaceuticals. Maind chapters: introduction to manufacturing, overview of physico-chemical methods (applications), overview of biological methods (cell-based assays, binding assays, measurement of impurities), case studies, quality assurance considerations, Quality by design.
Suggested:
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G. M. Cooper The Cell ASM Press Washington, 1997 A. J. Harwood Basic DNA and RNA Protocols Humana Press, 1996
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R. Westermeier Electrophoresis in Practice Wiley, 2005
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S. O. Krause Validation of Analytical Methods for Biopharmaceuticals PDA 2007
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L. R. Snyder, J.J. Kirkland, J.W. Dolan Introduction to Modern Liquid Chromatography Wiley 2010
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R. Freitag Modern Advances in Chromatography Springer 2002