CBE 5730
Transcript Abbreviation:
Industry BioPharm
Course Description:
Key technologies of industrial biopharmaceuticals (protein, cellular and gene therapies) will be introduced:
therapy development, unit operations, bioprocessing, biomanufacturing, GLP, cGMP, quality control, clinical
trials, and FDA regulations.
therapy development, unit operations, bioprocessing, biomanufacturing, GLP, cGMP, quality control, clinical
trials, and FDA regulations.
Course Levels:
Undergraduate (1000-5000 level)
Graduate
Designation:
Elective
General Education Course
(N/A)
Cross-Listings:
BIOMEDE 5830
Credit Hours (Minimum if “Range”selected):
3.00
Max Credit Hours
(N/A)
Select if Repeatable:
Off
Maximum Repeatable Credits
(N/A)
Total Completions Allowed
(N/A)
Allow Multiple Enrollments in Term:
No
Course Length:
14 weeks (autumn or spring)
Off Campus:
Never
Campus Location:
Columbus
Instruction Modes:
In Person (75-100% campus; 0-24% online)
Prerequisites and Co-requisites:
2200; or BIOMEDE 2000; or BIOCHEM 2210; or BIOLOGY 3401; or MOLGEN 2690; or permission of instructor; or graduate standing in Engineering
Electronically Enforced:
Yes
Exclusions:
BIOMEDE 5830
Course Goals / Objectives:
The development, bioprocessing and biomanufacturing, and evaluations of therapeutic proteins (e.g. monoclonal antibody, recombinant proteins) and cellular therapies (e.g. CAR-T, hiPSC, bacterial bug)
The development, bioprocessing and biomanufacturing, and evaluations of gene therapy (e.g. adeno-associated virus, oncoly)
This course will introduce students the growing biopharmaceutical and biotechnology industries using the FDA approved therapies and the advanced therapies that are evaluated in clinical trials as examples
It is targeted to offer the students marketable skills to work in a vital area of economic growth and also convey some of the challenges and opportunities awaiting students in Biotech industry
Importantly, the successful bioproducts and biopharmaceuticals, such as therapeutic proteins, cellular therapies, gene therapies, and biochemicals, will be used as examples to provide the students an overview of industrial biotechnology
In addition, the students with different backgrounds will be encouraged to collaborate and develop independent thinking and research abilities by doing specific projects
The students are expected to get familiar with the industrial achievement, clinical progress and the industrial requirements of pharmaceuticals, which will benefit their future academic research and industrial career development
This interdisciplinary course will advance the students’ exposure to biopharmaceutical industry, and will be a timely addition to broaden the skill set of the students and prepare them for emerging technologies
Check if concurrence sought:
Yes
Contact Hours:
| Topic | LEC | REC | LAB | LAB Inst |
|---|---|---|---|---|
| Cell culture technology for therapeutic protein including monoclonal antibodies and recombinant proteins, cellular therapies including T cell, dendritic cell, mesenchymal, pancreatic islet, iPSC or other therapeutic cells, gene therapies including.. | 9.5 | 0 | 0 | 0 |
| ...AAV oncolytic virus, RNA, CRISPR and others, and bacterial bugs | 0 | 0 | 0 | 0 |
| Recombinant DNA technology, cell line development, Omics technologies and cell engineering | 5.5 | 0 | 0 | 0 |
| Cell culture bioreactors design, selection, instrumentation and process control, cell culture kinetics and model, medium development, fed-batch cell culture process development and scale-up (protein, cells and virus) | 11.5 | 0 | 0 | 0 |
| Harvest, cell separation, product capture, multi-step purifications, downstream processing and scale-up, formulation, filling and packaging | 6.5 | 0 | 0 | 0 |
| Validation, qualification, quality control, facility design, progress and challenges of clinical trials, and FDA regulations | 6.0 | 0 | 0 | 0 |
| Total | 39 | 0 | 0 | 0 |
Grading Plan:
Letter Grade
Course Components:
Lecture
Grade Roster Component:
Lecture
Credit by Exam (EM):
No
Grades Breakdown:
| Aspect | Percent |
|---|---|
| Homework | 25% |
| Midterm | 25% |
| Project | 25% |
| Final Exam | 25% |
Representative Textbooks and Other Course Materials:
| Title | Author | Year |
|---|---|---|
| Cell Culture Technology for Pharmaceutical and Cell-Based Therapies | Wei-Shou Hu and Sadttin Ozturk | 2005 |
ABET-CAC Criterion 3 Outcomes
(N/A)
ABET-ETAC Criterion 3 Outcomes
(N/A)
ABET-EAC Criterion 3 Outcomes:
| Outcome | Contribution | Description |
|---|---|---|
| 1 | Significant contribution (7+ hours) | an ability to identify, formulate, and solve complex engineering problems by applying principles of engineering, science, and mathematics |
| 2 | Substantial contribution (3-6 hours) | an ability to apply engineering design to produce solutions that meet specified needs with consideration of public health, safety, and welfare, as well as global, cultural, social, environmental, and economic factors |
| 4 | Substantial contribution (3-6 hours) | an ability to recognize ethical and professional responsibilities in engineering situations and make informed judgments, which must consider the impact of engineering solutions in global, economic, environmental, and societal contexts |
| 7 | Significant contribution (7+ hours) | an ability to acquire and apply new knowledge as needed, using appropriate learning strategies |
Embedded Literacies Info
(N/A)
Attachments
(N/A)
Additional Notes or Comments
(N/A)