BIO09006 2019 SCALE-UP AND TECHNOLOGY TRANSFER

General Details

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 - NFQ Level 9
Credit
05 - 05 Credits
Duration
Stage
Fee
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Author(s)
Colin Fowley, Mary Butler
Programme Membership
SG_SBIOP_E09 201900 Level 9 Certificate in BioPharmaceutical Science SG_SBIOP_M09 201900 Master of Science in Biopharmaceutical Science SG_SBIOP_O09 201900 Postgraduate Diploma in Science in Science 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 Continuos Assessment 

 

 

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 Continuous Assessment Assignment 20 % Week 4 1
2 Continuous assessment-2 LAQ onlne quiz Continuous Assessment Closed Book Exam 30 % Week 11 1,2
3 Technical Project 40% Project Project 40 % Week 13 2,3
4 Technical Presentation Continuous 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 

URL Resources

https://www.fda.gov/scienceresearch/collaborativeopportunities/default.htm

Other Resources

Annex 7 WHO guidelines on transfer of technology in pharmaceutical manufacturing