This course will give an insight into the ever-increasing lists of prescribed biotechnology drug products (biologics) such as protein, nucleic acid based therapies (viral vectors for gene therapy) and immuno-therapeutics (monoclonal antibodies, virus-like particle vaccine candidates). The application of recombinant DNA technology and genetic engineering/manipulation for the generation of biopharmaceuticals or protein drugs/analogs with the desired/enhanced therapeutic properties will be highlighted in this course. Upstreaming (vector construct design & host cell selection) and downstreaming (purification, formulation, dispensing) processes in biopharmaceutical production will also be discussed. Topics related to Good Manufacturing Practices (quality assurance, process validation) for biotechnology-based products will also be taught. Students will also be given exposure regarding regulatory guidelines concerning biologics/biopharmaceutical drug approval and the various ethical, legal and social issues associated with biotechnology based products.
Skill Level: Beginner