BIOT221 Biomanufacturing

Department of Science, Technology, Engineering & Mathematics: Biotechnology

I. Course Number and Title
BIOT221 Biomanufacturing
II. Number of Credits
4 credits
III. Number of Instructional Minutes
IV. Prerequisites
BIOT125 (C or better) or permission of the department of Science, Technology, Engineering and Mathematics
V. Other Pertinent Information
Students with experience in science and laboratory work may be able to complete this course to gain biomanufacturing experience.
VI. Catalog Course Description
The course provides a solid foundation in the biomanufacturing process of biopharmaceuticals, including producing them under current Good Manufacturing Practices. Students use bacteria, mammalian and/or yeast cells to produce human proteins using the tools of manufacturing, such as upstream and downstream processing of proteins and quality control of protein production.
VII. Required Course Content and Direction
  1. Course Learning Goals

    Students will:

    1. describe the role of a biomanufacturing company and the various job categories in the developing of a biopharmaceutical product;
    2. define and describe the role of regulatory agencies in the biomanufacturing industry;
    3. recognize and define the role of Quality Assurance and Quality Control in the manufacturing process, including the development and utilization of the major documentation strategies, including SOPs, batch records, and training records;
    4. perform techniques involved in upstream processing, including growing bacteria, mammalian cells, and/or yeast cells, in a controlled environment;
    5. perform techniques involved in downstream processing, including purifying proteins and monitoring purity and activity using appropriate techniques, including but not limited to filtration, chromatography, ELISA, SDS-PAGE, and activity assays; and
    6. perform techniques that pertain to microbiological control, including LAL and mycoplasma detection assays, microbial identification, and environmental monitoring.
  2. Planned Sequence of Topics and/or Learning Activities

    1. introduction to the biomanufacturing industry
    2. operational excellence in the industry
    3. overview of facilities
    4. metrology
    5. validation
    6. environmental health and safety
    7. quality assurance
    8. microbiological control
    9. quality control biochemistry
    10. upstream processing
    11. downstream processing
    12. process development
  3. Assessment Methods for Course Learning Goals

    Student progress and achievement is assessed through lab reports, laboratory practical, project presentations, worksheets, take-home research assignments, and in-class exams and quizzes.
  4. Reference, Resource, or Learning Materials to be used by Student:

    Students use educational resources as approved by the department and specified in the individual instructor's syllabus.

Revision/Approval date - 3/2010; Revised 5/2013; New Core 8/2015