ALS 421
Mammalian Cell Culture and Microbial Fermentation Lab

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.

ALS 427 (prior or concurrently). ALS 312 and ALS 431

1. The ability to culture cells using proper aseptic technique, using small-scale disposable cell culture vessels, such as T-flasks, shakers, and/or roller bottles. The ability to successfully freeze down cells for long-term storage, and later thaw with high viability.

2. The ability to measure cell growth, death, and metabolism, using the analytical equipment in the Amgen Bioprocessing Center at KGI. This includes the ability to experimentally measure oxygen uptake rates in cell culture bioreactors.

3. An understanding of how mammalian cell culture operations are performed under current Good Manufacturing Practices (cGMPs) . The ability to follow Standard Operating Procedures (SOP) and a Master Batch Record (MBR). The ability to follow appropriate safety protocols, including knowledge of the required Biosafety Level (BSL).

4. The ability to predict, characterize, and investigate the impact of hydrodynamic mixing and shear, particularly in mixing-sensitive operations, such as transient transfections, or shear-sensitive operations, such as stem cell culture, from a fundamental, cell culture engineering perspective.

5. The ability to predict, characterize, and investigate the impact of gas-liquid mass transfer, including oxygen supply and carbon dioxide removal, from a fundamental, cell culture engineering perspective.

6. The ability to clean, sterilize, set-up, and operate a laboratory-scale bioreactor, for growth of a suspension culture of CHO cells in high-density, fed-batch culture.

7. An understanding of the latest offerings in new equipment and technologies for cell culture, including the technology needs and/or markets being addressed, the design bases, and performance evaluation criteria and data.

8. The ability to assess, track, and control culture pH, oxygen, temperature, major metabolites, and other environmental parameters.

9. An understanding of the metabolomics framework for analyzing culture data.

10. The ability to thoroughly analyze experimental cell culture results, illustrate the data graphically, properly interpret the results with appropriate statistical analyses, as well as prepare and provide summary reports and presentations.