BIO09006 2020 Scale-Up and Technology Transfer
Full Title
Scale-Up and Technology Transfer
Transcript Title
Scale-Up and Technology Transf
Code
BIO09006
Attendance
N/A %
Subject Area
BIO - Bio Tech/Eng/Chem
Department
LIFE - Life Sciences
Level
09 - Level 9
Credit
05 - 05 Credits
Duration
Stage
Fee
€
Start Term
2020 - Full Academic Year 2020-21
End Term
9999 - The End of Time
Author(s)
Colin Fowley, Mary Butler
Programme Membership
SG_SBCQV_E09 201900 Postgraduate Certificate in CQV Commissioning, Qualification and Validation for Biologics Manufacturing
SG_SVALI_O09 202300 Postgraduate Diploma in Science in Validation and Digitalisation Technologies
SG_SVALI_M09 202300 Master of Science in Validation and Digitalisation Technologies
SG_SCQVC_M09 202300 Master of Science in Commissioning, Qualification and Validation CQV for Biologics Manufacturing
SG_SVALD_O09 202300 Postgraduate Diploma in Science in BioPharmaceutical Validation and Digitalisation
SG_SBIOP_M09 202300 Master of Science in Biopharmaceutical Science
SG_SBIPR_M09 202300 Master of Science in Biopharmaceutical Processing
SG_SBIOP_O09 201700 Postgraduate Diploma in Science in Biopharmaceutical Science
SG_SBIOP_E09 201900 Postgraduate Certificate in BioPharmaceutical Science
Description
This module will provide an overview of the regulatory, technical and management issues associated with the scale-up and technology transfer of industrial bioprocesses. The focus will be on giving a clear understanding of the technical and regulatory requirements and approaches necessary to obtain regulatory approval for product scale-up and transfer. It will provide guidance on how to implement efficient and effective projects and will also address such areas as process validation and the typical costs associated with these projects.
Learning Outcomes
On completion of this module the learner will/should be able to;
1.
Discuss and evaluate the important process, engineering and regulatory aspects of technology transfer.
2.
Formulate and communicate effective planning of a technology transfer process.
3.
Provide some practical examples of technology transfer aspects and features.
Teaching and Learning Strategies
This Module will be delivered part time. This will include on line lectures augmented by independent learning and directed learning. This approach is expected to address student learning needs. Moodle will be used as a repository of educational resources and as a means of assessments.
Module Assessment Strategies
This Module is 100% Continuos Assessment
Continuous Assessment CA 1 Short written assessment (20%)
Will involve a short written assignment Assignment
Continuous Assessment CA 2 LAQ (30%)
LAQ online quiz Closed Book Exam
Continuos Assessment CA 3 Project Technical Project 40%
Based on a Tech Transfer operation from R&D to commercial manufacture
Continuous Assessment CA 4 Technical Presentation Assessment 10%
Presentation based on a Tech Transfer operation from R&D to commercial manufacture
Repeat Assessments
Repeat Continuous Assessment in line with marks and standards and Quality manual
Indicative Syllabus
Discuss and evaluate the important process, engineering and regulatory aspects of technology transfer.
Technology Transfer (Overview, Strategies, Planning); Regulatory Requirements (Clinical & Commercial Transfers); Selection of Utility Requirements; Process Technology & Validation; Analytical Method Transfer/Qualification; PAT (Process Analytical Technology); Process Scale up (Equipment/Validation/Regulatory Requirements);
Formulate and communicate effective planning of a technology transfer process.
Process Scale up (Equipment/Validation/Regulatory Requirements); Process Modelling (Scale down Systems); Integration of a New Process into Routine Operations on the Site;
Provide some practical examples of technology transfer aspects and features.
Integration of a New Process into Routine Operations on the Site; Cost of Technology Transfer & Ways to Ensure Project Success; Practical Examples of technology transfer.
The programme content will include the following topics:
Technology Transfer (Overview, Strategies, Planning); Regulatory Requirements (Clinical & Commercial Transfers); Selection of Utility Requirements; Process Technology & Validation; Analytical Method Transfer/Qualification; PAT (Process Analytical Technology); Process Scale up (Equipment/Validation/Regulatory Requirements); Process Modelling (Scale down Systems); Integration of a New Process into Routine Operations on the Site; Cost of Technology Transfer & Ways to Ensure Project Success; Practical Examples of technology transfer.
Coursework & Assessment Breakdown
Coursework & Continuous Assessment
100 %
Coursework Assessment
| Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
|---|---|---|---|---|---|---|
| 1 | CA 1 Short written assessment-1 (10%) will involve a short written assignment | Coursework Assessment | Assignment | 20 % | Week 4 | 1 |
| 2 | Continuous assessment-2 LAQ onlne quiz | Coursework Assessment | Closed Book Exam | 30 % | Week 11 | 1,2 |
| 3 | Technical Project 40% | Project | Project | 40 % | Week 13 | 2,3 |
| 4 | Technical Presentation | Coursework Assessment | Interview | 10 % | Week 13 | 2,3 |
Part Time Mode Workload
| Type | Location | Description | Hours | Frequency | Avg Workload |
|---|---|---|---|---|---|
| Lecture | Not Specified | Lecture | 2 | Weekly | 2.00 |
| Independent Learning | UNKNOWN | Self Study | 7 | Weekly | 7.00 |
Total Part Time Average Weekly Learner Contact Time 2.00 Hours
Module Resources
Non ISBN Literary Resources
Speser, P.L., The Art and Science of Technology Transfer., Wiley, 2006
Journal Resources
The Journal of Technology Transfer
ISPE Guide to Technology Transfer
ISPE 2018 Good Practice Guide: Technology Transfer 3rd Edition
PDA 2014 Technical Report No 65
URL Resources
https://www.fda.gov/scienceresearch/collaborativeopportunities/default.htm
www.ich.org
Other Resources
Annex 7 WHO guidelines on transfer of technology in pharmaceutical manufacturing
ISPE 2018 Good Practice Guide: Technology Transfer 3rd Edition
PDA 2014 Technical Report No 65
-Knowledge transfer Ireland; https://www.knowledgetransferireland.com/