BIOT 250 - Principles of Biomanufacturing

An overview of the processes and instrumentation required to produce a therapeutic protein or vaccine using cells as the manufacturing platform. Desirable host cell properties and methods of plasmid based selection. Survey of quality systems and cGMP in biomanufacturing including lean six sigma, RCA, CMCs, batch audits, specifications, and the role of QC and QA. Upstream processing focusing on bioreactors and process control, harvest and clarification. Downstream processing focusing on filtration and chromatography. A brief discussion of fill and finish. PREREQUISITE(S): BIOT 120 and BIOT 200 or consent of department. Three hours lecture.

3 semester hours

Course Outcomes:
Upon completion of this course, a student will be able to:

Define the elements of cGMP.
Describe elements of a quality system.
Describe host cells and selection systems.
Describe the key components of a stirred tank batch fed bioreactor.
Describe the role of process control in the manufacturing process.
Describe the different types of filtration and filter validation.
Describe the different types of chromatography and the associated parameters.
Compare upstream processing and downstream processing.

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