API: Synthesis & Characterization Specifications.

Catalog description

This course on Active Pharmaceutical Ingredients (APIs) is intended to provide a foundational understanding of synthetic route discovery including computational chemistry, designing drug molecules based on structure activity relationship and selection, hazards in industrial synthesis, flow chart presentation, process development and scale-up, and analysis of the APIs and impurities. Quality and regulatory issues in API development and manufacturing will be presented. In addition, an overall biologics-based process map beginning with production of APIs using recombinant technology utilizing Cell banks, plasmids, fermentation technology or E-Coli production process for therapeutic proteins/peptides, gene therapy etc., will be discussed. This is a hybrid course (>50% online) with distance-learning lectures and Canvas assignments. Prerequisites: Graduate student standing in the PCSP program or permission by instructor.