ALS 427: Mammalian Cell Biotechnology & Lab
Course Number: ALS 427
Course Name: Mammalian Cell Biotechnology & Lab
Year: Second-year
Semester: Fall
No. Units: 1.0
Faculty/Instructor(s): Matthew S. Croughan, KiriLynn Svay Hedberg
Description
Mammalian cell biotechnology has undergone explosive growth over the last 30 years. Recombinant Chinese Hamster Ovary (CHO) cells now far surpass E Coli and all other expression systems for recombinant protein production. Recombinant protein production levels have gone up 20,000-fold, are now often measured in grams per liter, and are expected to continue to increase. Mammalian cell culture is not only the most common system for production of marketed recombinant proteins, but is also the most common production system for proteins undergoing clinical testing. This leadership position, for both clinical and marketed products, also holds true for vaccines. Stem cell and engineered tissue therapies will ultimately require many new cell culture and/or cell processing operations. 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 in a series of lectures.
Prerequisites
ALS 331 or permission of instructor.
Learning Objectives
· the history and status of mammalian cell biotechnology, including past, current and future products, as well as challenges faced
· the biology of cultured cells, including cell growth, death, metabolism, mortality, transformation, differentiation, and adaptation
· laboratory operations and design, sterile technique, containment, and safety
· cell culture kinetics and modeling
· cell line engineering techniques and common host cell lines for recombinant protein and vaccine production
· design of cell culture medium and control of cell metabolism
· cell culture bioreactor design and scale-up, including aeration, mixing, and hydrodynamic/sparging impacts on cells, as well as instrumentation and process control
· design and operation of high-density fed-batch and perfusion cultures
· integration of cell culture processes with downstream product recovery and purification
· cell culture process characterization, validation, and troubleshooting
· manufacturing facility design and operations, from disposables to large-scale stainless steel, including cleaning and sterilization
· vaccine process development and manufacturing
· stem cell biology and the current status of stem cell therapy
· engineered tissues as replacement body parts and as replacements for animal testing
· key issues and tools used in industrial cell culture operations, including economies of scale, operations management, control charts, and process flow diagrams
Grading
Homework assignments: 33%
Midterm: 33%
Final exam: 34%
Grading standard: Most students receive a grade of A- or higher.
Required Texts