• CHE563: Fermentation of Recombinant Microorganisms
• BEC 575: Global Regulatory Affairs for Medical Products
• BEC577: Advanced Biomanufacturing and Biocatalysis
• BEC526: Upstream Biomanufacturing Laboratory
• BEC580: cGMP Fermentation Operations

Introduction to fermentation and protein chemistry. Theory behind laboratory techniques and overview of industrial scale expression systems. Laboratory sessions involve use of microbial expression vectors, fermentation systems, and large-scale purification of recombinant protein.

This lecture-based course introduces students to the quality systems used to meet the regulatory requirements for developing, testing, manufacturing, and selling medical products in the global marketplace. It provides a general background for those going into the medical products field, but is especially useful to students preparing for a career in the Regulatory Affairs or Quality Assurance Department within a pharmaceutical, biomanufacturing, or medical device company.

Overview of biomanufacturing using microorganisms [bacteria, yeast, fungi], eukaryotic cells [hybridomas, insect, plant, CHO] and recombinant enzymes focusing on methods used in industry. Course will emphasize process design for optimization of heterologous protein expression, metabolic/cell line engineering, metabolomics, protein engineering to alter enzymes and antibodies. Pathway engineering strategies include developing microbes to produce new therapeutic compounds or overproduce primary metabolites, antibiotics, biotherapeutics, therapeutic enzymes, diagnostics, recombinant vaccines, and biopharmaceuticals. Utilization of immobilized biocatalysts, and microbial kinetics are covered.

This course is an introduction to current food manufacturing practice [CGMP] as applied to the growth of microbial cells in bioreactors. Hands-on experience is obtained in the operation and control of 30 liter bioreactors to study agitation, oxygen transfer, cleaning, sterilization, media preparation and the growth of recombinant E. coli for protein production.

Application of microbial fermentation techniques at production scale and evaluation of the inherent issues resulting from the integration of microbial fermentation unit operations, scale-up/production, and current Good Manufacturing [cGMP] compliance. Lectures prepare students for pilot-scale laboratory experiences in media preparation, bioreactor operation, process utilities, and manufacturing quality systems that simulate microbial cell growth and product expression in a commercial cGMP facility.