Biologics Development - A Regulatory Overview Elective

Catalog description

This course will focus on the development of biologically derived therapeutics - such as vaccines, therapeutic proteins, recombinant DNA, and monoclonal antibodies - and their approval process by the U.S. Food and Drug Administration (FDA). Specific topics will cover modern bioengineering techniques that are utilized in the production of biotherapeutics, their preclinical and clinical evaluation protocols, and manufacturing arrangements. In addition, students will be exposed to quality assurance issues and related regulatory topics associated with successfully bringing biologics to the pharmaceutical market, including current good manufacturing practice regulations, to assure the quality of marketed biopharmaceutical products.