ALS 427
Mammalian Cell Biotechnology

Mammalian cell biotechnology has undergone explosive growth over the last 30 years. Persons skilled in mammalian cell biotechnology are in high demand. The primary goal of this course is to provide students with an advanced background in mammalian cell biotechnology. The scientific, engineering, and practical industrial aspects will be presented through a series of lectures and student group presentations.

ALS 431 and ALS 312

1. Understanding of safety regulations and protocols, particularly as they apply to the cell culture lab at KGI, as well as aseptic technique and methods to maintain pure cell cultures, free of contamination.

2. The ability to collect, analyze, and present information regarding industry-standard practices for maintaining freedom from contamination and proper containment upon scale up, for both mammalian cell culture processes as well as bioprocesses involving other expression systems and/or host cells.

3. Knowledge of the history and status of mammalian cell biotechnology, including past, current and future products, as well as challenges faced and forthcoming, including process economics, speed to the clinic, product quality issues, safety, contamination and containment, scale up and manufacturing capacity.

4. Understanding of the biology of cultured cells, including cell growth, death, physiology, mortality, transformation, differentiation, and adaptation. The ability to quantitatively analyze and model cell culture kinetics, including growth, death, and metabolism.

5. Knowledge of cell line engineering techniques and common host cell lines for recombinant protein and vaccine production

6. The ability to formulate cell culture medium and develop feeding strategies so as to control certain aspects of cell metabolism and enhance product safety and efficacy

7. A general (not engineering-level) understanding of the design of various cell culture bioreactor reactors and culture vessels.

8. Understanding of stem cell biology and the challenges regarding clinical testing and commercialization of cell therapies and gene therapies. The ability to collect, analyze, and present information regarding new cell therapy and gene therapy products and processes in development.