BIO09006 2008 SCALE-UP AND TECHNOLOGY TRANSFER

General Details

Full Title
SCALE-UP AND TECHNOLOGY TRANSFER
Transcript Title
SCALE-UP AND TECH TRANSFER
Code
BIO09006
Attendance
N/A %
Subject Area
BIO - Bio Tech/Eng/Chem
Department
ASCI - Applied Sciences
Level
09 - NFQ Level 9
Credit
05 - 05 Credits
Duration
Stage
Fee
Start Term
2008 - Full Academic Year 2008-09
End Term
9999 - The End of Time
Author(s)
Mary Butler
Programme Membership
SG_SBIOP_E09 200900 Certificate in Biopharmaceutical Science SG_SBIOP_M09 201300 Master of Science in Biopharmaceutical Science SG_SBIOP_M09 201700 Master of Science in Biopharmaceutical Science SG_SBIOP_E09 201700 Level 9 Certificate in Biopharmaceutical Science SG_SBIOP_O09 201700 Postgraduate Diploma in Science in Biopharmaceutical Science SG_SBIOP_M09 201300 Master of Science in Biopharmaceutical Science SG_SBIOP_M09 201700 Master of Science in Biopharmaceutical Science SG_SBIOP_M09 201700 Master of Science in Biopharmaceutical Science SG_SBIPR_M09 201900 Master of Science in Biopharmaceutical Processing
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.

Identify and explain the engineering aspects of bioprocess scale-up.

3.

Formulate and communicate effective planning of a technology transfer process.

4.

Explain the principal regulatory affairs aspects that have a bearing on technology transfer.

5.

Describe the key elements of PAT (Process Analytical technology).

6.

Outline the business management aspects of technology transfer and scale-up.

7.

Provide some practical examples of  technology transfer aspects and features.

Indicative Syllabus

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 The assessment approach for this module will be 100% Continuous Assessment with a range of assessment methods employed including some of the following: short-form assessment exams incl. MCQs, project assignments, practical work, essays, oral presentations, vivas etc. Continuous Assessment UNKNOWN 100 % OnGoing 1,2,3,4,5,6,7
             
             

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

Other Resources

None