PH3S111 - Process Development and Technology Transfer 01 Jan 2022 - 31 Aug 2028 | Version 1
Associated Module Information
| Module Code: | PH3S111 | ||
|---|---|---|---|
| Module Title: | Process Development and Technology Transfer | ||
| Faculty: | Faculty of Computing, Engineering and Science | ||
| Faculty Group: | Applied Sciences | ||
| Faculty Sub Group: | Chemistry and Pharmaceutical Science | ||
| Module Leader: | |||
| Module Team: | Suzanna Kean | ||
| First Intended Intake: | Final Year of Intake: | ||
| Date Closed: | |||
| Credit Value: | 20 | Credit Level: | 6 |
| Language: | English | ||
| Percentage of Module Taught in Welsh: | 0 | ||
| Equivalent Module: | |||
| HECOS codes: | 100078 - business and management | 100144 - pharmaceutical engineering | |
| HECOS Code Weighting: | 50 | 50 | |
Document Version Information
| Version | 1 |
|---|---|
| Valid From | 01 Jan 2022 |
| Valid To | 31 Aug 2028 |
Module Aims
The aim of this module is to give students a broad understanding of clinical, regulatory, and statistical processes involved in the development of new pharmaceutical product applications for drugs and biologicals. In addition, students will get an overview of how to transfer the new drug or biologic technologies to new and existing facilities.
Content Summary
Indicative Syllabus:
• Regulatory practices and procedures of new drug and biologics development
• Clinical research development
• Specific aspects in the process of new product submissions
• Global applications of good clinical practices (GCPs)
• Product approvals in the US and EU
• Overview of Technology Transfer strategies
• Process technology transfer and qualification
• Analytical method transfer and qualification
• Process modelling and scale up/down
• Integration of a new process into routine onsite operations
This module is delivered through open/distance learning resource packs, pre-recorded lectures, problem-solving exercises and case studies.
Learning and Teaching Methods
| Activity Type | Hours |
|---|---|
| Independent Study | 100 |
| Directed Study | 86 |
| Formative Assessment - Independent | 14 |
| Total Hours Selected | 200 |
Learning Outcomes
| # | Learning Outcome |
|---|---|
| LO1 | Describe the product development lifecycle, from clinical trials to full scale manufacturing and gain insight into regulatory considerations and how they are applied when developing new medicinal products. |
| LO2 | Apply the concept of product critical process parameters and quality attributes and product transfer. |
| LO3 | Understand the complexities that can be encountered when scaling up and transferring technologies across facilities and regulatory geographic regions. |
Module Requisites
N/A
Assessment Criteria
| Assessment Category | Assessment Type | Description | Duration | Word Count | Weight (%) | Best of? | Pass Mark |
|---|---|---|---|---|---|---|---|
| Asynchronous Assessment | Report 1 | Written assignment about “A practical model of the regulatory applications associated with technology transfer” | 0 | 2000 | 50 | No | 40 |
| Asynchronous Assessment | Literature/book/paper review 1 | Written review of a relevant industry book on bringing new drugs to market | 0 | 2000 | 50 | No | 40 |
Assessment Matrix
| Assessment Type | Learning Outcomes | ||
|---|---|---|---|
| LO1 | LO2 | LO3 | |
| Report 1 | ✔ | ✔ | ✔ |
| Literature/book/paper review 1 | ✔ | ✔ | ✔ |