Course |
Units |
Course Description |
| BIOT 401 Biomanufacturing Process Sciences and Engineering Principles (Lecture/Lab) |
5 |
Physical and chemical principles of biochemical engineering that enable large cell culture
Thermodynamics and the properties of fluids; mass and heat transfer, fluid flow, and the energy relationships in fluid systems
Biomanufacturing technologies enabling large scale upstream and downstream processes |
| BIOT 406 Supply Chain and Enterprise Resource Planning (Lecture) |
3 |
Manage flow of materials in a supply chain
Understand the design, planning and execution of raw material procurement and use
Eligibility for certification test |
| BIOT 402 Design of Experiments for Biomanufacturing (Lecture/Lab) |
4 |
Established methods to systematically vary process parameters to improve and optimize a biomanufacturing process |
| BIOT 407 Advanced Topics in Quality Assurance and Regulatory Affairs (Lecture) |
4 |
Study of the harmonized quality system approaches of ICH Q8, 9, 10, and 11, including quality risk management, qualification, and validation |
| BIOT 403 Design of Biomanufacturing Facilities, Critical Utilities, Processes, and Equipment (Lecture) |
4 |
An examination of how the robust design of all aspects of a biomanufacturing facility minimizes errors
The role of Quality by Design (ICH Q8) in facility design
Processes and equipment in biological production, recovery, and purification
Aseptic process design
Clean utility and support systems |
| BIOT 408 Six Sigma and Lean Manufacturing (Lecture/Discussion) |
4 |
Study of key six sigma concepts and tools; the DMAIC phases: design, measure, analyze, improve, and control
Use and implementation of lean tools to reduce waste
Completion of this course prepares students to earn a certification in six sigma |
| BIOT 404 Bioprocess Monitoring and Control (Lecture/Lab) |
5 |
The measurement, monitoring, modeling, and control of biomanufacturing processes
|
| BIOT 409 Methods in Quality Improvements , Investigations, and Audits (Lecture) |
4 |
The study of continuous quality improvement techniques, including investigational methods into process deviations |
| BIOT 405 Emerging Biomanufacturing Technologies (Seminar) |
3 |
An examination of new technologies in biological production and purification operations |
| BIOT 410 Emerging Trends in Biomanufacturing Quality (Seminar) |
3 |
An examination of new regulatory requirements and changes to current practices in biomanufacturing quality |
