BIO09006 2008 SCALE-UP AND TECHNOLOGY TRANSFER
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.
On completion of this module the learner will/should be able to;
Discuss and evaluate the important process, engineering and regulatory aspects of technology transfer.
Identify and explain the engineering aspects of bioprocess scale-up.
Formulate and communicate effective planning of a technology transfer process.
Explain the principal regulatory affairs aspects that have a bearing on technology transfer.
Describe the key elements of PAT (Process Analytical technology).
Outline the business management aspects of technology transfer and scale-up.
Provide some practical examples of technology transfer aspects and features.
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
|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
|Independent Learning||UNKNOWN||Self Study||7||Weekly||7.00|
Speser, P.L., The Art and Science of Technology Transfer., Wiley, 2006