Bioprocess Technology in API Manufacturing

This course provides a broad overview of topics related to the design and operations of modern biopharmaceutical facilities. It covers process, utilities and facility design issues, and encompasses all major manufacturing areas, such as fermentation, harvest, primary and final purification, media and buffer preparation, equipment cleaning and sterilization, and critical process utilities. Unit operations include cell culture, centrifugation, conventional and tangential flow filtration, chromatography, solution preparation, and bulk filling. Application of current Good Manufacturing Practices and Bioprocessing Equipment Standards (BPE-2002) will be discussed. The course will benefit students majoring in the sciences, engineering, manufacturing technology, and management, who are interested in getting broad knowledge of processes, equipment, and design considerations pertaining to modern biopharmaceutical manufacturing.