Biopharmaceutical Manufacturing
Description
Manufacturing processes for biopharmaceuticals must be designed to produce products that have consistent quality attributes. This manufacturing process involves fermentation technologies, product recovery and the removal of impurities and contaminants that include endotoxins, viruses, cell membranes, nucleic acids, proteins, culture media components, process chemicals, and ligands leached from chromatography media, as well as product modifications, aggregates, and inactive forms. This module is designed to provide the student with a comprehensive understanding of the manufacturing process involved in the production of biopharmaceuticals.
Learning Outcomes
Illustrate and implement an understanding of the key steps involved in the development of a biopharmaceutical drug.
Evulate and critical appraise the technologies,processes and the technical parameters pertinent to the upstream and downdstream procceses in biopharmaceutical manufacturing.
Analyse and apply knowledge of the key parameters in biopharmaceutical product formulation, lyophilization, fill, packaging and labelling.
Corroborate an indepth knowledge of the key parameters in biopharmaceutical analysis.