BTEC 2211 Syllabus
Subject Code
BTEC
Course Number
2211
Course Title
Industrial Cell Culture and Immunology
Prerequisites
BTEC 2192 with a grade of C or higher, BTEC 2192L with a grade of C or higher
Corequisites
BTEC 2211L
Terms Offered
Offered every semester
Credit Hours
(2-0-2)
Course Description
This course teaches the skills needed to serve as a technician in an FDA-regulated biotechnology production facility. The course emphasizes the use of current Good Manufacturing Practices (cGMP), and students gain experience writing and following Standard Operating Procedures (SOPs). Upstream (fermentation, hybridoma cell growth, bioreactor preparation) and downstream (protein chromatography, tangential flow filtration, quality control assays) processes are described and correlate with laboratory activities. Essential concepts in immunology such as cell-mediated and antibody-mediated immune responses, vaccines, and monoclonal antibodies are also discussed.
Course Outcomes
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History of the Food and Drug Administration (FDA)
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Order
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Description
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1
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To describe historical pharmaceutical-related tragedies and the resulting legislations enacted
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2
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To relate the Food, Drug and Cosmetic Act of 1906 to the founding of the FDA
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3
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To describe the organizational structure and program centers of the FDA
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GMP documentation
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Order
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Description
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1
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To describe the Code of Federal Regulations and how they relate to Good Manufacturing Practices
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2
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To develop Standard Operating Procedures (SOPs)
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3
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To produce a batch of microwave popcorn with GMP documentation (batch records, SOPs, cleaning logs, etc.)
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4
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To produce a batch of purified protein with GMP documentation (batch records, SOPs, cleaning logs, etc.)
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5
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To explain the concept of validation of processes and equipment
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Upstream biomanufacturing processing
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Order
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Description
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1
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To describe various methods for growing cells in culture
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2
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To explain the advantages/disadvantages of protein expression systems of bacteria, yeast, and higher eukaryotic cells
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3
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To explain the Pichia pastoris recombinant protein expression system
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4
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To describe the probes and control systems of fermenters/bioreactors
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Downstream biomanufacturing processing
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Order
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Description
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1
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To explain various methods for separating cells from growth medium
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2
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To describe different types of protein chromatography
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3
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To explain the concept of tangential flow filtration
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4
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To explain a variety of quality control assays in biomanufacturing such as microbial testing, LAL assay, and ELISA
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Cell-mediated and antibody-mediated immune responses
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Order
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Description
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1
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To explain the origin and roles of various immune cells such as B cells, T cells, macrophages, dendritic cells
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2
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To describe the production of monoclonal antibodies
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3
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To describe antigens and antigen presentation by the immune system
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4
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To describe the role of T cells in cell-mediated immunity
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5
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To describe the role of B cells and plasma cells in antibody-mediated immunity
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6
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To differentiate the properties of antibody isotypes
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Vaccines
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Order
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Description
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1
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To discuss the history of vaccines
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2
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To describe recent approaches to production of vaccines
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3
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To describe the mechanism of action of new DNA vaccines and pulsed dendritic cells
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