ALS 423: Fundamentals of Commercial Biotech Operations
Course Number: ALS 423
Course Name: Fundamentals of Commercial Biotech Operations
Year: Second year
No. Credits: 1.5
Faculty/Instructor(s): Rick Johnston
Over the last two decades, billions of dollars have flowed into research and development of biopharmaceutical medicines by research organizations and biopharmaceutical companies. However the focus of research has historically been centered on drug discovery and development, rather than on operational issues relating to drug manufacture. In the last 5-10 years has there been increasing recognition that the biopharmaceutical supply chain presents a unique production challenge not addressed by any single existing body of research. Major investment in Operational Excellence initiatives at all of the major biopharmaceutical companies is just one example of such a focus on operations.
This course focuses on issues specific to operations in biotechnology, including high variability in process operations, the need for very high supply reliability ('no patient goes without') as well as long cycle times for biotech manufacturing. Students will use cutting-edge mathematical tools and models currently developed for the industry to deal with these issues, and examine in detail the elements of modern biopharmaceutical processing and commercial automation. The focus of the course will be to give students a practical toolset for measuring and improving operational efficiency at a process as well as supply chain level. We will look at current industry practice in Lean manufacturing, Operational Excellence initiatives and how they should be adapted to deal with biotech issues. We will also look at evaluating financial metrics for such improvements using simple financial models.
The course consists of lectures and in-class case studies using process modeling and simulation modeling software.
- An overview of large-scale biotech manufacturing, including automation systems at both bulk and fill / packaging facilities
- Characterizing variability and using simulation to measure and understand variability
- Causes of variability and their impact on the biotech supply chain
- Dealing with variability using various kinds of buffering
- Lean production methodology and how to reduce waste in a facility
- Introduction to inventory, supply chains, and push-pull methods in supply chains
- The bullwhip effect and the value of information in the supply chain
- Risk Management in biotech
- Financial models used to justify process improvements
In-class assignments: 50%
Final exam: 50%