BIOT 5020 Bioprocesses and industrial regulations
Analysis of the essential elements of Bioprocesses. Application of the processes and methods used in the production of biological molecules with a focus on the biomanufacturing industry. Emphasis on Upstream and Downstream operations. Study of the role of FDA regulation in the generation and distribution of high-quality products that comply with industry regulations, including Good Manufacturing Practices (cGMP) and Good Laboratory Practices (cGLP). Requires 30 hours of lecture and 45 hours of laboratory.