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2022/23 Taught Postgraduate Module Catalogue

BIOL5320M Practical Skills for a Regulatory Environment

20 creditsClass Size: 33

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

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.

Students must pass BIOL5320M to proceed to BIOL5392M Project module. Any student who has a provisional fail mark will be advised that they cannot continue onto BIOL5392M project at this time. They will be advised that they can resit the module and if they pass they can start BIOL5392M the next academic session. Alternatively they can transfer to the PG Dip Biopharmaceutical Development programme and take BIOL5291M literature project module (30 credits).

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. Project management will form a core part of the module and students will be expected to set and meet objectives to defied timescales, working individually and occasionally in teams. Learning will be assessed during the practical sessions, written reports after each practical and a final viva in a format suitable to a client or regulatory authority evaluating whether a defined molecule has attributes lending itself to being a biopharmaceutical and therefore meriting further Research and Development investment. Students will also be expected to complete a set of practical competencies and maintain a log reflecting on project progress and team performance.

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:
- 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.


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 typeNumberLength hoursStudent hours
Workshop11.001.00
Workshop42.008.00
presentation10.500.50
Lecture51.005.00
Practical18.008.00
Practical116.0016.00
Practical123.0023.00
Practical215.0030.00
Private study hours108.50
Total Contact hours91.50
Total hours (100hr per 10 credits)200.00

Private study

Private study will include undertaking background reading associated with the practicals, preparing for workshops and practicals, analysing the data generated and preparing assessment tasks. The module assessment includes an individual reports for each practical, assessment of attitude during practical, and a viva at the end of the sessions.

Opportunities for Formative Feedback

A member of academic staff will be allocated as a tutor to each group. They will meet each week to discuss the progress against a project plan and to set objectives for the next period.

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.

Methods of assessment


Coursework
Assessment typeNotes% of formal assessment
VivaThe viva will allow the student to present their work package to a small panel of academics representing the developer.30.00
ReportIndividual report in the style of submission to a commercial client or regulatory authority70.00
Total percentage (Assessment Coursework)100.00

The format of resit will be an alternative assignment

Reading list

There is no reading list for this module

Last updated: 11/08/2022

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