This course covers the theory, practice and interpretation of the various assays and instrumentation routinely employed in a biologics analysis and quality control testing laboratory. A number of attributes can potentially impact the drug safety and efficacy of the Biological therapeutics. This course will focus on the core analytical technqiues routinely employed in the the analysis of biological therapeutics. The course will cover methods such as spectroscopic, chromatographic, electrophoretic and mass spectrometric approaches for the analysis of biological therapeutics and emerging technologies as they arise. The course will cover testing for biological acitvities and quaility of the vaccine using microbiological methods based on the type of the vaccien itself. In addition, we will rund quality control for each vaccine using biological assays.
None