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 moduleLast updated: 21/12/2023 14:47:28
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- Undergraduate module catalogue
- Taught Postgraduate module catalogue
- Undergraduate programme catalogue
- Taught Postgraduate programme catalogue
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