CHEN40130 Bioprocess Scale-up and Technology Transfer

Academic Year 2022/2023

This module will examine the process involved in scaling up both upstream and downstream biologics manufacturing processes and the transfer of manufacturing and analytical methods from one site to another including technical, regulatory and project management considerations. This module will be delivered by industrial experts from biopharmaceutical manufacturing companies.

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Curricular information is subject to change

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

Student Effort Hours: 
Student Effort Type Hours
Autonomous Student Learning

90
Lectures

16
Total

106
Approaches to Teaching and Learning:
Lectures
Case studies 
Requirements, Exclusions and Recommendations

Not applicable to this module.


Module Requisites and Incompatibles
Not applicable to this module.
 
Assessment Strategy  
Description Timing Open Book Exam Component Scale Must Pass Component % of Final Grade
Assignment: Assignment Coursework (End of Trimester) n/a Graded No

85
Continuous Assessment: Three in-class exercises Throughout the Trimester n/a Graded No

15

Carry forward of passed components
Yes
 
Resit In Terminal Exam
Summer No
Please see Student Jargon Buster for more information about remediation types and timing. 
Feedback Strategy/Strategies

• Feedback individually to students, post-assessment

How will my Feedback be Delivered?

Not yet recorded.

Name Role
Professor Niall Barron Lecturer / Co-Lecturer
Ms Grainne Ryan Lecturer / Co-Lecturer