This course is designed to explore the cells and molecules of the immune system as it relates to the structure, function and safety of biological drug products. The first half of this course serves as an introduction to immunology. The structure and function of critical cellular and soluble immune system components are discussed including: antigen-presenting cells, major histocompatibility complex proteins, T lymphocytes, B lymphocytes, cytokines, antibodies and complement proteins. During the second half of the course the lectures focus on the fundamental molecular interactions involved in immunological responses as it relates to the measuring and testing of drug safety and biologic immunogenicity in a research and regulated environment. This course will explore historical case studies, current products on the market, and burgeoning trends in the biologics space in the context of knowledge gained throughout.