Module manager: Dr Anton Calabrese
Email: A.Calabrese@leeds.ac.uk
Taught: Semesters 1 & 2 (Sep to Jun) View Timetable
Year running 2024/25
A first degree (BSc hons) in a Biological Sciences subject, Bioprocessing or Biochemical Engineering: class 2(i) or above.
BIOL5320M - Practical Skills for a Regulatory Environment
This module is not approved as an Elective
The module will provide students with hands-on practical experience of performing biopharmaceutical analyses consistent with standards applied in a regulatory environment. Students will perform a series of experiments demonstrating stages along the drug development pathway. Topics covered will include: assay validation (accuracy, precision, robustness, in-specification), followed by three practical strands; one focusing on molecular/biophysical protein characterisation (GMP-focus; antibody purification, SDS-PAGE, and protein quantification), the second on ELISA assays, and the third on cell-based assays (GCP-focus cell growth/viability). The practicals will be supported by a series of lectures and workshops covering the theory underpinning the techniques, analysing data and feedback on reports.
The objectives are for students to:
- Understand the practice of laboratory work within a highly-regulated environment;
- Appreciate the theory and practice of a range of techniques relevant to the biopharmaceutical industry;
- Provide experience in data collection and analysis, report writing and presentation;
- Examine effective working practices for teams in a laboratory setting.
On completion of the module, students should be able to:
1. Demonstrate a critical understanding of biopharmaceutical assay validation, specification and performance;
2. Evaluate the strengths and weaknesses of a range of techniques relevant to the biopharmaceutical product development pathway;
3. Perform a range of analytical techniques using sophisticated instrumentation to analyse biopharmaceuticals;
4. Analyse and interpret data and present their findings in writing and orally in a format suitable to a client or regulatory authority;
5. Understand the basis of good project management and teamwork.
- Managing Knowledge: Data evaluation / problem solving.
- Technical Competence: laboratory techniques; experimental design; analysing data.
- Managing Self: planning, time management.
- Managing Interrelationships - Teamwork; Decision taking; Learning from others; Sharing; Receiving critique.
- Presentation Skills: report writing and oral presentation.
The module will cover the following:
- Assay validation, specification and assessment of accuracy, precision and sources of error;
- The downstream-processing technologies for production and characterisation of the function of biopharmaceutical molecules;
- Measurement of bioactivity and potency of biopharmaceuticals in cell-based assays;
- The theory and practice of project management and effective teamwork.
| Delivery type | Number | Length hours | Student hours |
|---|---|---|---|
| presentation | 1 | 0.5 | 0.5 |
| Lecture | 2 | 1 | 2 |
| Practical | 1 | 8 | 8 |
| Practical | 2 | 5 | 10 |
| Practical | 4 | 7 | 28 |
| Practical | 5 | 3 | 15 |
| Seminar | 1 | 3 | 3 |
| Seminar | 3 | 1 | 3 |
| Seminar | 3 | 2 | 6 |
| Private study hours | 224.5 | ||
| Total Contact hours | 75.5 | ||
| Total hours (100hr per 10 credits) | 300 | ||
Practical tutors and demonstrators will be available during the practical sessions to answer any questions the students may have and monitor understanding of their work. Supplementary workshops will be conducted after each practical to discuss the project plan and set future objectives, with a tutor facilitating small group discussions.
| Assessment type | Notes | % of formal assessment |
|---|---|---|
| In-course Assessment | 10 short answer questions (time limited) | 20 |
| Viva | The viva will allow the student to present their work package to a small panel of academics representing the developer. The Viva will last a maximum of 20 minutes including presentation and questions. The presentation should be a maximum of 10 slides. | 20 |
| Report | Individual report in the style of submission to a commercial client or regulatory authority. Report length of no longer than 10 pages. | 60 |
| Total percentage (Assessment Coursework) | 100 | |
Normally resits will be assessed by the same methodology as the first attempt, unless otherwise stated
There is no reading list for this module
Last updated: 31/07/2024
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