This is a half-credit course that introduces students to some of the key aspects of the biopharmaceutical process, with special emphasis on the biotech sector. The course focuses on the fundamental role played by corporate entities in the development of new therapeutic drugs in a highly regulated business environment. Topics covered include biopharmaceutical manufacturing, regulatory approval for drug products and medical devices, setting regulatory standards, quality-by-design, cGMP compliance, risk management, and root cause analysis.