- Module code: BS973
- Module name: Biopharmaceutical Product and Clinical Development
- Department: School of Life Sciences
- Credit: 10
Module content and teaching
"This module is designed to equip students with the knowledge and skills base to guide a potential new biopharmaceutical product through the regulatory, product approval and marketing stages of commercialisation. It is a core module for the MSc in Biotechnology, Bioprocessing and Business Management which when combined with other electives in the biopharmaceutical area will provide a new industrial focus for students pursuing this Masters programme. The context of this module is that it sits within a programme that seeks to explain the increasing importance of integrating knowledge transfer, key regulatory and ethical issues, protection of ideas generation and funding to commercialisation. "
Principal learning outcomes
Subject knowledge and understanding: By the end of the module the student should have a broad knowledge and understanding of biopharmaceuticals; development, pre-clinical safety studies, regulatory agencies policies and guidelines; manufacture; chemistry, manufacture and control (CMC); good manufacturing practice and quality assurance; regulation and regulatory authorities. Recognise and analyse the problems associated with the development and use of biopharmaceuticals in a commercial process. Recognise the underlying principles re clinical trials, manufacture and commercial implementation of biopharmaceuticals. The role of a multi-disciplinary approach in the commercialisation of biopharmaceuticals. Be aware of issues involved in the exploitation of a biopharmaceutical process. Demonstrate an understanding of ethical issues pertinent to exploitation and commercialisation of biopharmaceuticals.
Timetabled teaching activities
Lectures per week 10 x 1 hour; Seminar sessions 8 x 1 hour.
|Assessment group||Assessment name||Percentage|
|10 CATS (Module code: BS973-10)|
|D2 (Assessed/examined work)||1st Case Study Seminar Presentation||10%|
|2nd Case Study Seminar Presentation||10%|
|3rd Case Study Seminar Presentation||10%|
|4th Case Study Seminar Presentation||10%|
|5th Case Study Seminar Presentation||10%|
|6th Case Study Seminar Presentation||10%|
|MCQ examination (locally held)||40%|
This module is available on the following courses: