Manufacturing and Formulation of Therapeutic Proteins

Catalog description

Discussion of therapeutic proteins used for various conditions, including cancer, autoimmune and inflammatory diseases, infectious processes, and genetic disorders. Study of methods for delivering protein drugs at the nanoscale. Application of chromatographic strategies to purify therapeutic proteins and use of analytical techniques to determine their biochemical quality attributes. These techniques will simulate those used during downstream processes. Includes the identification of cellular impurities using mass spectrometry. Applicable manufacturing regulations are considered. Requires 30 lecture hours and 45 laboratory hours.