Analysis of Protein-Based Drugs
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.
G. M. Cooper The Cell ASM Press Washington, 1997 A. J. Harwood Basic DNA and RNA Protocols Humana Press, 1996
R. Westermeier Electrophoresis in Practice Wiley, 2005
S. O. Krause Validation of Analytical Methods for Biopharmaceuticals PDA 2007
L. R. Snyder, J.J. Kirkland, J.W. Dolan Introduction to Modern Liquid Chromatography Wiley 2010
R. Freitag Modern Advances in Chromatography Springer 2002