BIOT221 Biomanufacturing

Department of Science, Technology, Engineering & Mathematics: Biotechnology

I. Course Number and Title
BIOT221 Biomanufacturing
II. Number of Credits
4 credits
III. Minimum Number of Instructional Minutes Per Semester
4500
IV. Prerequisites
BIOT125 (C or better) or permission of the STEM department
Corequisites
None
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. Learning Goals:

    1. Course
    2. 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.

    3. Core (if applicable)
    4. This course is not included in the Core.
  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 Core Learning Goals:

    1. Course
    2. Student progress and achievement will be assessed through lab reports, laboratory practical, project presentations, worksheets, take-home research assignments, and in-class exams and quizzes.

    3. Core (if applicable)
    4. This course is not included in the Core.
  4. Reference, Resource, or Learning Materials to be used by Students:

    Students use educational resources as approved by the department and specified in the individual instructor's format.
VIII. Teaching Methods Employed
Section VIII is not being used in new and revised syllabi as of 12/10/08.

Revision/Approval date - 3/2010; Revised 5/2013