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CHE 577 Advanced Biomanufacturing and Biocatalysis

3 Credit Hours


Overview of biomanufacturing using microorganisms (bacteria, yeast, fungi), eukaryotic cells (insect, plant, CHO) and recombinant enzymes focusing on methods used in industry. Course will emphasize media and process design for optimization of heterologous protein expression, metabolic/cell line engineering, metabolomics, protein engineering to alter enzymes and antibodies. Pathway engineering strategies include developing microbes to produce new therapeutic compounds or overproduce primary metabolites, antibiotics, biotherapeutics, therapeutic enzymes, diagnostics, recombinant vaccines, and biopharmaceuticals. Utilization of immobilized biocatalysts, and microbial kinetics are covered.

Prerequisite

Graduate standing in engineering or life science graduate program or consent of instructor. Previous coursework in microbiology, cell biology, microbial biochemistry or molecular biology will be helpful.

Learning Objectives

  1. Explain the scientific basis underlying the use of products relevant to advanced biomanufacturing, including antibody and antibody-like products, vaccines, and cell and gene therapies.
  2. Evaluate methods used in advanced biomanufacturing for production of therapeutic proteins, vaccines, cell and gene therapies, and other industrially relevant biochemicals. Identify methods and processes that are most suitable for a product.
  3. Evaluate the effect of intellectual property considerations and regulation by the US Food and Drug Administration (FDA) on development of products and biomanufacturing strategy.

Course Requirements

Class attendance and participation (5%)
Class participation and engagement is a vital part of the course. Access to course materials/videos will be used to track engagement. Additionally, we expect that students will participate in discussion on the discussion forum online (as prompted by the instructor), and complete peer review assignments.

Homework (75%; 12 HW)
Homework will largely focus on reading that is assigned in the previous class. Examples include involve making a set of PowerPoint slides (~ 10) that summarize an article assigned for reading, or answering questions based on readings.

Technology brief (15%) and oral presentation (5%)
Technology brief: Students will work on a concise paper that discusses a technology solution to a contemporary biomanufacturing problem. The instructor will provide suggestions for topics, and students are required to meet in person (or over phone/Zoom) with the instructor prior to finalizing the topic. The technology brief will be a 10-page concise paper (single spaced, Times New Roman 12 pt. font, 1” margins; figures included within page limit; references/bibliography does not count towards page limit).

Oral presentations: Students will prepare an oral presentation (PowerPoint or equivalent) and create a narrated presentation. All presentations will be posted on the course website.

Peer evaluation of technology brief and oral presentation.
Each student will be required to peer-review at least one paper and one presentations, and provide feedback using an instructor-assigned format. Up to 75% of the class participation grade will be based on these peer reviews.

Course Content and Structure

This course is organized into four modules that focus on important classes of products that are relevant to advanced biomanufacturing. The modules are:

  1. Antibodies and antibody-like proteins
  2. Vaccines
  3. Cell and gene therapies
  4. Other biochemicals (focus is on biocatalysis and microbial engineering)

 In each module, we will examine various aspects of biomanufacturing that are relevant to that class of product such as choice of recombinant host for protein expression and role of intellectual property and FDA regulation.

Textbook

There is no textbook required for this course. All course resources will be available on the course Moodle site.

Computer and Software Requirements

Please review minimum computer specifications recommended by NC State University and Engineering Online.

Updated 11/04/2022