Learning Outcomes:
On completion of this module students should be able:
1. Understand the best practices for successful bioprocess scale-ups and technology transfers (TTs)
2. Understand the typical project phases of TTs
3. Understand the typical components of TTs including the Charter, the scope of gap and risk assessments between donor and receiving sites and the assessment tools available.
4. Develop regulatory strategy for making changes to marketing authorisations and the pathway for reduced variation categories as a result of a scale up or technology transfer
5. Develop a process validation plan and analytical method transfer plan
6. Understand the organisational structure of a technology transfer team
7. Understand the different scale-up strategies for upstream and downstream process equipment
8. Understand the approach to validating a scale-up or technology transfer and the necessary studies
9. Case studies of scale ups and technology transfers in the Irish biopharmaceutical industry