The Proceedings of the BIRS Community


This paper describes the Biotechnology Innovation and Regulatory Science course named The Molecular Basis of Manufacturing. This course covers drug manufacture including excipients, basic formulation, basic DOE analysis, and analysis of the final drug product (typically tablets or capsules). Molecular interpretation of formulations is discussed. The modules in the course are described as well as other course materials including quizzes and discussion questions. This paper will assist with the development of course in this area throughout the entire world.