MEDT 410 Product Development/Commercial Applications
This course is designed to introduce and familiarize the student with the process of product development within the biotechnology industry. In addition, the process of taking a product from inception through FDA approval will be discussed. Lectures will concentrate on defining a product for commercialization through research and development, small-scale and large scale manufacturing processes, optimization, validation and verification processes. Clinical trials will be discussed as well as data analysis and clinical evaluations. The course will also focus on the commercial applications of biotechnology-derived products. Specific applications include biopharmaceutical products, in-vitro diagnostic products, medical devices and agricultural products. Industry professionals will be utilized for lectures in their areas of expertise.