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2022/23 Taught Postgraduate Module Catalogue

BIOL5325M Practical Skills For A Regulatory Environment (part-time)

20 creditsClass Size: 6

Module manager: Dr Darren Tomlinson

Taught: 1 Sep to 31 Mar View Timetable

Year running 2022/23

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

BIOL5320MPractical Skills for a Regulatory Environment

This module is not approved as an Elective

Module summary

The module will provide students with the practical experience of performing biopharmaceutical analyses consistent with standards applied in a regulatory environment. Students will demonstrate competence in a series of experiments demonstrating stages along the drug development pathway. Topics 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 and teamwork, 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.


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:
- demonstrate a critical understanding of biopharmaceutical assay validation, specification and performance;
- evaluate the strengths and weaknesses of a range of techniques relevant to the biopharmaceutical product development pathway;
- perform a range of analytical techniques using sophisticated instrumentation to analyse biopharmaceuticals;
- analyse and interpret data and present their findings in writing and orally in a format suitable to a client or regulatory authority;
- understand the basis of good project management and teamwork.


The module will cover the following:
- assay validation, specification and assessment of accuracy, precision and sources of error;
- a series of at least 5 techniques used in biopharmaceutical drug development;
- the theory and practice of project management and effective teamwork.

Teaching methods

Delivery typeNumberLength hoursStudent hours
Private study hours189.50
Total Contact hours10.50
Total hours (100hr per 10 credits)200.00

Private study

Private study will include compilation of portfolio of practical skills and competence (and making up for any practical deficiencies), undertaking background reading associated with the practicals (in portfolio), preparing for tutorials, analysing the data generated and preparing assessment tasks. The module assessment includes an individual report demonstrating that the student’s previous experience meets the objectives of the course, and a viva on the topic of the student’s report.

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.
Students understanding of data analysis will be monitored by tutors leading the data-handling workshops.

Methods of assessment

Assessment typeNotes% of formal assessment
Essay3000 word essay that demonstrates with specific examples how the student meets the learning outcomes of the module through their professional practice.70.00
Oral PresentationViva on content of essay30.00
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: 26/07/2022


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