Introduction to BioPharma

This module provides an introduction to the Bio Pharmaceutical Industry. A basic overview of the process of manufacturing a bulk drug substance & drug product will be provided. It highlights the diverse business models that exist in the industry including: Large Scale Manufacturing, Basic Research, Virtual Enterprises, Contract Manufacturing Organizations, Contract Research Organizations, the roll of Universities, and Consulting. The role of the FDA and similar regulatory agencies is discussed along with the various industry professional organizations and their role. The module also covers unique aspects on Good Manufacturing Practice. Finally the module will discuss the current industry trends in terms of manufacturing migration, and international process equipment vendors