BIOT250 — 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. Three hours lecture. 3 semester hours Course
Prerequisites: BIOT120, BIOT200