2024/25 Taught Postgraduate Module Catalogue

BIOL5323M Practical Skills for a Regulatory Environment 

30 creditsClass Size: 35

Module manager: Dr Anton Calabrese
Email: A.Calabrese@leeds.ac.uk

Taught: Semesters 1 & 2 (Sep to Jun) View Timetable

Year running 2024/25

Pre-requisite qualifications

A first degree (BSc hons) in a Biological Sciences subject, Bioprocessing or Biochemical Engineering: class 2(i) or above.

Module replaces

BIOL5320M - Practical Skills for a Regulatory Environment

This module is not approved as an Elective

Module summary

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.

Objectives

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.

Learning outcomes
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.

Skills outcomes
- 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.

Syllabus

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.

Teaching methods

Delivery type	Number	Length hours	Student hours
presentation	1	0.50	0.50
Lecture	2	1.00	2.00
Practical	1	8.00	8.00
Practical	2	5.00	10.00
Practical	4	7.00	28.00
Practical	5	3.00	15.00
Seminar	1	3.00	3.00
Seminar	3	1.00	3.00
Seminar	3	2.00	6.00
Private study hours			224.50
Total Contact hours			75.50
Total hours (100hr per 10 credits)			300.00

Opportunities for Formative Feedback

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.

Methods of assessment

Coursework

Assessment type	Notes	% of formal assessment
In-course Assessment	10 short answer questions (time limited)	20.00
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.	20.00
Report	Individual report in the style of submission to a commercial client or regulatory authority. Report length of no longer than 10 pages.	60.00
Total percentage (Assessment Coursework)		100.00

Normally resits will be assessed by the same methodology as the first attempt, unless otherwise stated

Reading list

There is no reading list for this module

Last updated: 31/07/2024

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