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BEC 590
Industry Practicum in Biomanufacturing (Biomanufacturing Case Studies)

The Industry Practicum Case Studies course provides students with the opportunity to design a complete cGMP process and facility capable of being licensed by the U.S. FDA to manufacture a multi-valent human vaccine or a therapeutic product. Expression platforms, downstream separation operations, project management, QC/QA, facility design, and regulatory compliance problems related to the design of the cGMP biomanufacturing process will be solved by groups of students using multiple process approaches. A redesign of the existing BTEC facility will be the basis for solving problems of how to design a process and facility capable of being licensed by the FDA. A timeline and budget will be developed for facility remodeling, equipment modification, validation, and manufacturing for release of a specified number of doses for the market in a defined time period will also be included.