CHBE474

Prerequisite: BIOE120; and permission of instructor. Restriction: Permission of ENGR-Chemical & Biomolecular Engineering department. Credit only granted for: CHBE474, BIOE489T, or ENCH648D. Covers the fundamental steps involved in process development and manufacturing of biopharmaceuticals. An overview of different classes of biopharmaceuticals as well as manufacturing requirements for clinical development and regulatory approval will be provided. In depth coverage of manufacturing steps including cell culture, purification and formulation as well as drug product manufacturing, analysis and stability will be covered. Scientific literature will be used to highlight current challenges and novel solutions in each step of the manufacturing process. Scale up considerations, GMP requirements and process economics will also be introduced.