Upstream and Downstream Manufacturing of Biological Products

Catalog description

This is a foundation course for the biomanufacturing field, introducing basic regulatory protocols such as batch records and standard operating procedures, which are commonly used in accordance with Federal Drug Administration guidelines. Upstream processing, which includes the growth and maintenance of cell cultures, use of equipment such as the biological safety cabinet and bioreactor preparation of primary cell cultures, cell preservation techniques, downstream processing, which includes columns, tangential filtration, Western Blot, ELISA and product formulation are explored. This course includes provides lab-based instruction and training in upstream and downstream manufacturing processes used in the production of a biologics-based therapeutic products.