In this course, the bioanalysis of biopharmaceuticals is discussed and the technical aspects of method development are reviewed in the light of the final assay objectives in industry. Integrated bioanalytics relies on a variety of important methods to acquire reliable information about the state of a biological system, e.g. by analyzing tissues, body fluids. As compounds differ in their physico-chemical properties, appropriate analytical strategies are required for sample separation, pre-treatment, detection methodology and validation. Students will acquire the necessary knowledge to understand the most common methods applied and will be able to define the basic needs to develop and perform integrated biomolecular analyses, as well as to review and evaluate studies in the bioanalytical field. Finally, the relation (physico- chemical features) between and interaction (drug-protein interactions, adverse-drug reactions) of biopharmaceuticals and relatively small-drug related compounds will be overviewed. With respect to the methodologies applied, the power of (biological and immuno-) assays and mass spectrometry-based procedures will be highlighted.
