Module manager: Dr Dimitra Mitsa
Email: D.Mitsa@leeds.ac.uk
Taught: Semester 1 (Sep to Jan) View Timetable
Year running 2026/27
A first degree (BSc Hons) in a Biological Sciences subject, Bioprocessing or Biochemical Engineering: class 2(i) or above.
BIOL5167M - Manufacturing Biopharmaceuticals
This module is not approved as an Elective
The module on Manufacturing of Biopharmaceuticals will provide an in-depth introduction to Biologics manufacturing. The ability to quickly develop and economically manufacture new therapeutics is becoming ever more critical and this course will prepare students with the background required for a career in this area. Specifically, it will build on knowledge provided earlier in the course on the types of biologics used, and consider how these can be scaled-up. The module will address issues such as mode of operation, process variables and optimisation, material inputs and outputs, analytics and control, secondary processing and formulation, regulatory safety and legal aspects. The learning outcome is a heightened and detailed awareness of the issues faced during scale-up and manufacture.
The objectives are to:
- Provide industry relevant insight into key aspects of biologics manufacturing and how it fits into overall biopharmaceutical drug development.
- Develop awareness of the activities and operations involved in process development and manufacturing.
- Enable students to develop a deeper understanding of the relationship between the mechanism of action, the critical quality attributes of the molecule and manufacturing process.
- Develop an understanding in analytical systems support, their characterisation and quality control.
- Develop an understanding of options for product formulation to enable clinical development and commercially successful products.
- Develop an appreciation of the importance of quality assurance, regulatory, safety and legal aspects.
- Provide awareness of business aspects of manufacture and the supply chain.
On completion of this module students will be able to:
1. Describe the range of activities involved in biopharmaceutical manufacture.
2. Critically anlayse the technical, operational, regulatory and commercial aspects of manufacture.
3. Design a manufacturing project of a biological molecule using effective team working and. managing interpersonal relationships.
The following elements will be presented and discussed with reference to Industry examples to illustrate Industry development and growth of Biopharmaceutical manufacturing.
- The requirements of Biopharmaceutical manufacturing and its role in drug development.
- Analytical method development and data to support regulatory submission.
- Upstream and downstream processing.
- Formulation, excipients, stability and monitoring methods.
- Change control, comparability assessment and process validation.
- General considerations of productivity, costs, Quality by Design, product release.
| Delivery type | Number | Length hours | Student hours |
|---|---|---|---|
| presentation | 1 | 4 | 4 |
| Fieldwork | 1 | 9 | 9 |
| Lecture | 6 | 3 | 18 |
| Tutorial | 1 | 1 | 1 |
| Tutorial | 1 | 2 | 2 |
| Private study hours | 116 | ||
| Total Contact hours | 34 | ||
| Total hours (100hr per 10 credits) | 150 | ||
Private study is required in support of both the Group Project and Oral presentation that will involve considerable individual contributions. The remaining private study is in support of widening understanding of the lecture material.
The two tutorials are used to guide and advise students for the two assignments required in the module. The students are split into groups during the tutorials and various aspects of the assignments are discussed.
| Assessment type | Notes | % of formal assessment |
|---|---|---|
| Group Project | Single written report per team with individual and team components | 70 |
| Oral Presentation | Group presentation with panel Q&A | 30 |
| Total percentage (Assessment Coursework) | 100 | |
Resits for the group project and presentation will be in the form of an alternative piece of individual coursework (e.g., individual report and poster, individual presentation), which will allow each student to independently demonstrate their understanding of the key concepts, processes, and challenges involved in the manufacturing of biopharmaceuticals.
Check the module area in Minerva for your reading list
Last updated: 30/04/2026
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