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 influenza vaccine or a therapeutic monoclonal antibody or antibody fragment. Expression platforms, downstream separation operations, project management, QC/QA, facility design and regulatory compliance problems related to the design of a monoclonal antibody or human influenza 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 representing 20% of the market in a defined time period.