Description
This course is the third in the series of cornerstone courses in Biotechnology and Good Manufacturing Practice and the second of three courses in Biomanufacturing. This lab- based course is designed to give students experience in various aspects of biomanufacturing including but not limited to: Process development, Quality Control, Environmental Health and Safety, and Upstream and Downstream Processing. The course begins with the aseptic techniques involved in the culturing and preservation of mammalian and yeast cells. Scale-up techniques (upstream processing) will then be used to culture a 1 milliliter volume of cells (106) into 3-10 liter columns containing many trillions of cells (1012). An in- depth discussion of downstream processing techniques such as tangential flow filtration and protein purification systems will be utilized to purify a protein product (drug) from the cell media. Strict adherence to current good manufacturing practices (cGMP) will be followed and the protein p