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May 04, 2024
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2022-2023 Catalog [ARCHIVED CATALOG]
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BIOT 217 - Biotechnology Manufacturing Processes
PREREQUISITES: Program Advisor Approval
PROGRAM: Biotechnology
CREDIT HOURS MIN: 3
LECTURE HOURS MIN: 3
DATE OF LAST REVISION: Summer, 2011
Students will be introduced to the processes and procedures involved in the manufacture of biological molecules on both large- and small-scales. The student will learn the function of commonly used manufacturing equipment associated with biotechnology and understand the cGMP’s associated with the use of such equipment. The regulatory environment associated with most biotechnology endeavors will be reviewed including those mandated by FDA, USDA and OSHA.
MAJOR COURSE LEARNING OBJECTIVES: Upon successful completion of this course the student will be expected to:
- Understand cGMP’s that apply to those processes discussed in class.
- Be able to recognize and explain the function of commonly used apparatus in small-scale production processes.
- Understand the perimeters that must be monitored and controlled in small-scale production processes.
- Comprehend the mechanisms by which monitoring and control is accomplished in small- scale production facilities.
- Comprehend cGMP’s that are applicable to small-scale production processes.
- Understand the regulatory environment that impacts small-scale production facilities and how such a facility complies with these regulations.
- Comprehend the problems associated with “scale-up” of processes from small-scale to large-scale production.
- Be able to recognize and explain the function of commonly used apparatus used in large-scale production processes.
- Understand the perimeters that must be monitored and controlled in large-scale production processes.
- Comprehend the mechanisms by which monitoring and control is accomplished in large- scale production facilities.
- Comprehend cGMP’s that are applicable to large-scale production processes.
- Understand the regulatory environment that impacts large-scale production facilities and how such a facility complies with these regulations.
COURSE CONTENT: Topical areas of study include -
- cMP
- Regulatory compliance
- Processes control
- Processes monitoring
- Process scale-up
- Environmental monitoring
- Bioburden control
- Room classification
- Process automation
- Equipment control
- Control theory
Course Addendum - Syllabus (Click to expand)
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