410.673 Biological Processes in Regulatory Affairs

This course provides an overview of the biological processes and laboratory techniques utilized for the discovery, development and evaluation of therapeutic drugs. Students investigate drug development processes such as gene cloning, culture scale-up, downstream processing, and product purification. Emphasis is placed on the theory and application of laboratory methods used in drug development, such as recombinant DNA techniques, antibody technology, protein purification, immunoassays, high-throughput drug screening, chromatography, electrophoresis, cell receptor characterization, pharmacokinetics, drug toxicity testing and evaluation of therapeutic drugs, diagnostics, and vaccines.
Prerequisites: 410.601 Biochemistry; 410.603 Cell Biology or admissions to the MS in Bioscience Regulatory Affairs

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