2023/24 Taught Postgraduate Module Catalogue

BIOL5326M Practical Skills for a Regulatory Environment (PT)

30 creditsClass Size: 15

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

Taught: 1 Sep to 31 Mar View Timetable

Year running 2023/24

Pre-requisite qualifications

A first degree (BSc hons) in a Biological Sciences subject, Bioprocessing or Biochemical Engineering: class 2(i) or above. Relevant experience may be taken into account.

This module is mutually exclusive with

BIOL5323M

Practical Skills for a Regulatory Environment

Module replaces

BIOL5325M - Practical Skills for a Regulatory Environment (part-time)

This module is not approved as an Elective

Module summary

Students will demonstrate competence in a series of reports demonstrating their abilities of practical elements along the drug development pathway. These may include: assay validation (accuracy, precision, robustness, in-specification), molecular/biophysical protein characterisation (GMP-focus; antibody purification, SDS-PAGE, and protein quantification), ELISA assays, and cell-based assays (GCP-focus cell growth/viability). Other techniques relevant to drug development of similar complexity will be included. Project management will form a core part of the module and students will be expected to understand the basis of good project management. Students will also be expected to create a portfolio of practical competencies and understand how their current and previous job roles meet the objectives of the module.

Objectives

On completion of this module, students should be able 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.

Syllabus

The module will cover the following:
- assay validation, specification and assessment of accuracy, precision and sources of error;
- a series of at least 5 laboratory techniques used in biopharmaceutical drug development that you are currently using or have used in the past – may include ELISA, MS, HPLC to name a few;
- the theory and practice of project management and effective teamwork.

Teaching methods

Delivery type	Number	Length hours	Student hours
Supervision	2	1.00	2.00
presentation	1	0.50	0.50
Lecture	5	1.00	5.00
Tutorial	10	1.00	10.00
Private study hours			282.50
Total Contact hours			17.50
Total hours (100hr per 10 credits)			300.00

Opportunities for Formative Feedback

A member of academic staff will be allocated as a tutor to each student. They will meet during scheduled tutorials to support the learning in this module as groups and as individuals.

Methods of assessment

Coursework

Assessment type	Notes	% of formal assessment
Essay	3000 word essay that demonstrates with specific examples how the student meets the learning outcomes of the module through their professional practice.	50.00
Portfolio	Portfolio of practical competence in 5 relevant experimental techniques	0.00
Oral Presentation	Viva on content of essay 20 min presentation	30.00
Literature Review	1000 word essay that demonstrates understanding of a technique that is new to them and is relevant to industry.	20.00
Total percentage (Assessment Coursework)		100.00

The Portfolio is pass/fail and a pass mark must be achieved to pass the module, otherwise a V code will be applied. The format of resit will be an alternative assignment.

Reading list

There is no reading list for this module

Last updated: 21/12/2023 14:47:28

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