This laboratory course provides extensive hands-on experience in KGI’s lab-scale pilot plant for animal cell culture (part of the Amgen Bioprocessing Center). The pilot plant includes several 2-L glass bioreactors plus various single use systems, all run as scale-down models of large scale (25,000-L) systems. The course includes not only laboratory exercises and written reports, but also certain weekly classes wherein students will receive additional instruction, occasionally give presentations on their results, and see talks and demonstrations by vendors on their latest technologies.
MEng program students only
- Topics covering the current and future trends in biopharmaceuticals- from simple proteins to monoclonal antibodies (to gene and cell therapy).
- Learn how to develop a process from a molecule to an API, using materials and principles learned from other MEng engineering classes.
- Describe and define the role of FRD’s risk based approach – Define critical Quality Attributers (CQAs), Quality-byDesign (QbD) and Six Sigma in process design and development.
- Introduce the concept of Chemistry- Manufacturing and Control (CMC) strategy and how it is used to guide process design and development.