Introduction to Bioprocessing

Bioprocessing is the basis for the manufacture of products to allow the translation of discoveries in life sciences to viable healthcare treatments. Business leaders in the life sciences must be capable of understanding the priorities and resources required for successful product development and commercialization. The primary goal of this course is to provide students with an awareness of biomanufacturing opportunities and challenges. The course provides background in biotechnology and describes the operations used in large-scale production of important biologic products. Business, scientific and practical industrial aspects will be presented through a series of lectures, interactive discussions, and student group presentations.

1. What is bioprocess engineering and what do bioprocess engineers do?
2. Define current and next generation Biopharmaceuticals and thier impacts on healthcare – Give examples
3. Describe the development pathway of a typical biopharmaceutical focusing on Bioprocess Development and Manufacturing.
4. Define and describe the differences between molecule specific and platform processes
5. Define the role bioprocessing and differentiate between the key aims of major unit operations in a modern biomanufacturing operation.
6. Describe key steps and operations in developing an upstream process
7. Define cell line development process, media selection and optimization and bioreactor design.
8. Differentiate between upstream and downstream processing.
9. List differences in protein production using bacteria, yeast, animal, and plant cells.
10. Describe key principles involved in upstream and downstream operations.
11. List key ingredients used in cell culture medium and medium supplements, and describe the function of these
ingredients.
12. Compare and contrast batch, fed-batch and continuous modes of bioreactor operation.
13. Discuss scale-up of bioreactors and criteria to consider in bioreactor scale-up.
14. Describe factors that impact cell growth and metabolism.
15. Discuss the importance of monitoring culture pH, oxygen, temperature and major metabolites in bioreactors.
16. Discuss some of the ways in which protein products are harvested, and purified.
17. Describe the importance of viral clearance and inactivation in purified protein products.
18. Describe and define key unit operations in purification including different forms of chromatography,
precipitation and crystallization
19. Describe the formulation of purified protein products.
20. Describe tangential flow filtration (TFF) and its role in API process
21. Describe the role of viral inactivation and viral clearance strategy in mammalian cell culture operations
22. Describe and define the role of FRD’s risk based approach – Define critical Quality Attributers (CQAs), Quality-byDesign
(QbD) and Sis Sigma in process design and development.
23. Introduce the concept of Chemistry- Manufacturing and Control (CMC) strategy and how it is used to guide
process design and development.
24. Describe the current and future trends in biopharmaceuticals- from simple proteins to monoclonal antibodies to
gene and cell therapy.
25. Describe the term biosimilars and discuss the process development and regulation of biosimilars.