Pharmaceutical manufacturing is vital to the success of the technical operations of a pharmaceutical company. This course is approached from the need to balance company economic considerations with the regulatory compliance requirements of safety, effectiveness, identity, strength, quality, and purity of the products manufactured for distribution and sale by the company. Overview of chemical and biotech process technology and equipment; dosage forms and finishing systems; facility engineering; health, safety, and environment concepts; and regulatory issues.

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.

Proven techniques and creative tools presented for design, development, and delivery of biopharmaceutical manufacturing facilities.  Includes skills and knowledge in bioprocessing requirements, equipment and facility requirements, project management as well as regulatory guidelines and “big-picture” drug development. Also corporate capital management processes to functionally meet corporate requirements from pre-clinical to commercial scale of operations, qualifications to pass regulatory inspections, achieving faster “time-to-market,” but not breaking the corporate treasury bank.  Course also explores trends in new equipment technology such as disposables or single-use product, new design concepts in aseptic manufacturing, barrier and isolation technologies, new FDA thinking in risk-based compliance approach, process analytical technology, capital project planning and management.

This course is primarily for engineers in the Master of Engineering program.