PME 539: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.
Carol Nolan has over 30 years of experience in the pharmaceutical and biotechnology industries. Her specialties include process development for microbial and cell culture derived products, clinical production operations management, technology transfer, biopharmaceutical plant design, and quality systems. Nolan is President of Techniceutica, a consulting firm, and previously worked for Amgen, Immunex, SmithKline Beecham, Monsanto, Pfizer, and Upjohn. Nolan holds an MS in Chemical and Biochemical Engineering from the University of Pennsylvania.