2016/17 Taught Postgraduate Module Catalogue
BIOL5397M Practical Skills for a Regulatory Environment
25 creditsClass Size: 30
Module manager: Dr Iain Manfield
Email: i.manfield@leeds.ac.uk
Taught: Semesters 1 & 2 (Sep to Jun) View Timetable
Year running 2016/17
Pre-requisite qualifications
A first degree (BSc hons) in a Biological Sciences subject, Bioprocessing or Biochemical Engineering: class 2(i) or above.Pre-requisites
BIOL5164M | Biopharmaceutical Development Pathway |
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 two practical strands; one focusing on molecular/biophysical protein characterisation (GMP-focus; antibody purification, SDS-PAGE, bio-potency activity assay by ELISA, binding assay by e.g. SPR) and the second on cell-based assays (GCP-focus; flow cytometry, confocal microscopy, cell growth/viability). The practicals will be supported by a series of lectures and workshops covering the theory underpinning the techniques, analysing data and preparing 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 in teams or individually. Learning will be assessed through a written report and an oral presentation 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 structure and 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 |
Workshop | 1 | 1.00 | 1.00 |
Workshop | 1 | 12.00 | 12.00 |
Workshop | 4 | 2.00 | 8.00 |
presentation | 1 | 3.00 | 3.00 |
Class tests, exams and assessment | 1 | 3.00 | 3.00 |
Lecture | 14 | 1.00 | 14.00 |
Practical | 1 | 6.00 | 6.00 |
Practical | 1 | 18.00 | 18.00 |
Practical | 3 | 12.00 | 36.00 |
Tutorial | 2 | 1.00 | 2.00 |
Private study hours | 147.00 | ||
Total Contact hours | 103.00 | ||
Total hours (100hr per 10 credits) | 250.00 |
Private study
Private study will include undertaking background reading associated with the lectures, preparing for workshops and practicals, analysing the data generated and preparing assessment tasks. The module assessment includes a group presentation, an individual report, practical test and a reflective log. Thus private study will be a combination of individual work and group study.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.
The reflective log will be reviewed and discussed periodically with the appropriate tutor.
Methods of assessment
Coursework
Assessment type | Notes | % of formal assessment |
Report | Final report (in the style of submission to a commercial client or regulatory authority) | 50.00 |
Oral Presentation | Final group presentation of their practical work, pitch to a client or regulatory authority | 20.00 |
Practical | Objective structured practical examination (OSPE): Practical tests across four activities: 1) ELISA data analysis for accuracy and precision, 2) Calculations and reagent preparation, 3) Biacore SPR binding data analysis and 4) SOP revision | 30.00 |
Total percentage (Assessment Coursework) | 100.00 |
Reflective log = P/F
Reading list
There is no reading list for this moduleLast updated: 10/08/2016
Browse Other Catalogues
- Undergraduate module catalogue
- Taught Postgraduate module catalogue
- Undergraduate programme catalogue
- Taught Postgraduate programme catalogue
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