Description
This course is the second in the series of cornerstone courses in Biotechnology and Good Manufacturing Practice and the first of three courses in Biomanufacturing. This lab- based course is designed to introduce the student to the high-tech world of manufacturing prescription drugs. The course begins with an overview of biomanufacturing, its rapid growth and the industries need for well-trained employees. We examine the need for the Food and Drug Administration (FDA) and their requirements for current good manufacturing practices (cGMP). The student will become skilled in the techniques and equipment necessary to manufacture a recombinant protein. The goal of the course is to manufacture a mammalian protein in bacteria following cGMP’s and standard operating procedures through upstream and downstream processes. Quality control methods will stringently test the protein product and validate its purity. Prerequisites: CHE121, BIO111, and BTC101.