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CHEN40130

Academic Year 2024/2025

Bioprocess Scale-up and Technology Transfer (CHEN40130)

Subject:
Chemical Engineering
College:
Engineering & Architecture
School:
Chem & Bioprocess Engineering
Level:
4 (Masters)
Credits:
5
Module Coordinator:
Dr Colin Clarke
Trimester:
Spring
Mode of Delivery:
On Campus
Internship Module:
No
How will I be graded?
Letter grades

Curricular information is subject to change.

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.

About this Module

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
Lectures

16

Autonomous Student Learning

90

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 Component Scale Must Pass Component % of Final Grade In Module Component Repeat Offered
Assignment(Including Essay): Assignment 1 Week 6 Standard conversion grade scale 40% No
30
No
Assignment(Including Essay): Assignment 2 Week 14 Standard conversion grade scale 40% No
50
No
Exam (Online): MCQ Exam Week 10 Standard conversion grade scale 40% No
20
No

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 Lisa McDonald Lecturer / Co-Lecturer

Timetabling information is displayed only for guidance purposes, relates to the current Academic Year only and is subject to change.
Spring Lecture Offering 1 Week(s) - 20, 22, 24, 25 Fri 14:00 - 17:50