Project-based course directly working with biotechnology and pharmaceutical companies. Students work in teams on a company-specific project. Projects range from developing business or marketing plans for new products; writing Small Business Innovation Research (SBIR) grants or white papers; creating procedures, protocols, and/or process improvements for a company-specific process; and studying intellectual property issues. Written and oral communication skills as well as teamwork, flexibility, and ambiguity management are emphasized.

This course provides advanced principles of genetic engineering in yeast and mammalian cells for the overproduction of a protein of interest. Students will use classical and novel (CRISPR) strategies to establish a stable Chinese hamster ovary (CHO) cell line based on the industrially relevant strain, DG44 (DHFR system). Students will also generate a yeast expression system based on Pichia pastoris for the production of the same protein (monoclonal antibody). The generation of two different cell lines for the overproduction of the same protein of interest should provide students with an appreciation of each system in terms of cost, speed, productivity and product quality.

Process validation is a tested and documented subset of the panel of activities that are performed during the production of a biopharmaceutical. This course examines the concept of process validation as it applies to the biotechnology industry, and more specifically, to the manufacture of protein molecules as therapeutic agents.

This course provides an overview of the principles of quality management, assurance and control in the food and bioprocessing industries. The objectives are for students to be able to identify government regulations, private industry standards, and customer expectations that are relevant to food and bioprocessing, apply root cause analysis methodologies, apply and evaluate control charts for monitoring process control for variables and attributes, conduct process capability analyses, apply statistical hypothesis testing, and design producer and/or customer-centered sampling plans. Lab activities alternate between guest speakers from industry and exercises in which students develop their abilities to apply computer programs to solve quality problems

This course examines fundamental molecular biology techniques, applied to generate bacterial cell lines for the production of recombinant proteins. Course material provides a comprehensive description of an expression system, with emphasis on the central dogma of molecular biology, detailed gene structure, vector components and bacterial host cell characteristics. Different genetic, physiologic and growth condition aspects are included to ensure the overproduction of a functional protein of interest. This comprises different molecular approaches for gene cloning, bacterial selection/screening and regulation of genetic expression. The course provides hands-on experience during laboratory sessions, where students isolate a gene of interest, clone the gene into an expression vector, transform bacteria, select for positive clones, grow recombinant cells, and induce the production of the protein of interest. Techniques such as SDS-PAGE, Western blot, and ELISA are used for the detection and quantification of the active recombinant protein.