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CHEG 667-011 CULTURE BIOMANUFACTURING 867–016 Advanced BIOMANUFACTURING (although listed as a SEMINAR, this is a regular course as described below)

Extra meeting times for graduate students (CHEG 867-016): see below

SPRING 2019 Room TBD Monday & Wednesday: 5 – 6:15 PM (tentatively; registration catalog will have correct time slot)

Course Description: The production of protein therapeutics and , and the emerging applications of stem-cell and cell therapy applications in the treatment of cancer or in regenerative-medicine applications rely largely on the ability to culture animal and human cells at various scales. The protein therapeutics industry, largely focused on the production of therapeutic antibodies, is a fast-growing $140B+ industry that employs a large number of engineers to enable the production of these difficult molecules. More than any other sector of the industry, this sector employs more than 75% of the chemical engineers and bioengineers to attend to the needs of the R&D and production chains, both upstream (cell culture) and downstream (protein purification and formulation) in the manufacturing process. The new NIST/UD Biomanufacturing Institute (NIIMBL; http://www.niimbl.us) is focused on these processes.

This course will introduce students to the essential scientific principles and their applications in cell-culture biomanufacturing. Starting with principles of cell biology and mammalian metabolism, it will cover cell-line development, media development, stoichiometry and kinetics of cell culture, metabolic flux analysis, bioreactor design and operation, scale up, process-analytical technology (PAT), protein glycosylation as related to manufacturing and product quality, genomics of production cell lines, genome editing, and protein purification and formulation. In addition, the course will include discussion and analysis of modern literature (led by students), and guest lectures by UD faculty but also scientists outside UD. Graduate students will also work on a term research paper.

Prerequisite: students with some prior course exposure to biology (cell biology and/or biochemistry).

TEXT: an eBook by Prof. WS Hu (U. Minnesota) and collaborators will be the formal course companion, with specific reading assignments Instructor: E. Terry Papoutsakis [email protected] 831-8376 (office): 284 DBI (325 in CLB)

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