The programme will provide integrated understanding of the industrial pathway of biological drug discovery, development and exploitation. Modules exist for each of the major technical functions of this industry (discovery, manufacturing, pre-clinical testing, clinical safety and efficacy, laboratory analytical skills). Further modules introduce the course & industry (pathway, regulatory framework, economic value, and societal drivers), to address commercialisation of biopharmaceutical products and a final taught module that integrates topics in the form of project work submitting a new biochemical entity to a regulatory body. This will provide students with a deep understanding of core elements of the discipline, and a good appreciation of the broader context and regulatory framework of the industry. It is highly interdisciplinary, and will equip students to work in such teams.
There will be a strong emphasis on the acquisition of technical skills necessary for biological drug development and so a substantial component of the programme will be devoted to practical training including a taught practical skills module (Practical Skills for a Regulatory Environment). The practical skills module will introduce students to the techniques used in the biopharma industry and the standards to which they are applied within a regulatory environment. Thus students will perform a series of experiments demonstrating stages along the drug development pathway working under GLP/GMP/GCP instruction as far as is possible within university laboratories. Topics covered will include: assay validation (accuracy, precision, robustness, in-specification), followed by two practical strands; one focusing on molecular/biophysical protein characterisation (GMP-focus; antibody purification, SDS-PAGE, bio-potency activity assay by ELISA, binding assay by e.g. SPR) and the second on cell-based assays (GCP-focus; flow cytometry, confocal microscopy, cell growth/viability). During the research project, students will have the opportunity to apply this training, thus building on, and extending these skills.
[Learning Outcomes, Transferable (Key) Skills, Assessment]
View Timetable
Candidates will be required to study the following compulsory modules:
| Code | Title | Credits | Semester | Pass for Progression |
|---|---|---|---|---|
| BIOL5124M | Introduction to Pharmaceutical Science and Commerce | 15 | Semester 1 (Sep to Jan) | |
| BIOL5181M | Manufacturing Biopharmaceuticals | 15 | Semester 1 (Sep to Jan) | |
| BIOL5208M | Integrated Drug Development Plan | 15 | Semester 2 (Jan to Jun) | |
| BIOL5210M | Biopharmaceutical Development: Clinical | 15 | Semester 2 (Jan to Jun) | |
| BIOL5323M | Practical Skills for a Regulatory Environment | 30 | Semesters 1 & 2 (Sep to Jun) | |
| BIOL5384M | Biopharmaceutical drug discovery and non-clinical testing | 30 | Semesters 1 & 2 (Sep to Jun) | |
| BIOL5393M | Bioscience MSc Research Project | 60 | 1 Feb to 30 Sep | PFP |
Last updated: 29/08/2024 16:04:11
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