This module delves into the development and manufacture of biologics or biopharmaceuticals and high value protein-based drugs that include monoclonal antibodies, growth factors using genetically modified expression hosts. Students will learn about upstream manufacturing science, which includes industrial bioreactor types, bioreactor design, cell inoculation, monitoring of growth parameters, shutdown and harvest of cultures, downstream processing operations like affinity and size exclusion chromatography and tangential flow filtration. Topics in this module will also focus on contamination control procedures and operations in a controlled clean room environment. Significant aspects of biologics quality assurance and control through implementation of current Good Manufacturing Practice (cGMP), Good Documentation Practice (GDP) and their impact on product quality and safety will also be covered.
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