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2022/23 Taught Postgraduate Module Catalogue

BIOL5181M Manufacturing Biopharmaceuticals

15 creditsClass Size: 33

Module manager: Dr Darren Tomlinson
Email: D.C.Tomlinson@leeds.ac.uk

Taught: Semester 1 (Sep to Jan) 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.

Pre-requisites

BIOL5164MBiopharmaceutical Development Pathway

Module replaces

BIOL5167M - Manufacturing Biopharmaceuticals

This module is not approved as an Elective

Module summary

The module on Manufacturing of Biopharmaceuticals will provide an in-depth introduction to Biologics manufacturing. The ability to quickly develop and manufacture economically new therapeutics is becoming ever more critical and this course will prepare students with the background required for a career in this area. Specifically it will build on knowledge provided earlier in the course on the types of biologics used, and consider how these can be scaled-up. The module will address issues such as mode of operation, process variables and optimisation, material inputs and outputs, analytics and control, secondary processing and formulation, regulatory safety and legal aspects. The learning outcome is a heightened and detailed awareness of the issues faced during scale-up and manufacture.

Objectives

The objectives are to:
- Provide industry relevant insight into key aspects of biologics manufacturing and how it fits into overall biopharmaceutical drug development.
- Develop awareness of the activities and operations involved in process development and manufacturing.
- Enable students to develop a deeper understanding of the relationship between the mechanism of action, the critical quality attributes of the molecule and manufacturing process.
- Develop an understanding in analytical systems support, their characterisation and quality control.
- Develop an understanding of options for product formulation to enable clinical development and commercially successful products.
- Develop an appreciation of the importance of quality assurance, regulatory, safety and legal aspects.
- Provide awareness of business aspects of manufacture and the supply chain.

Learning outcomes
On completion of the module, students should be able to:
- Describe the range of activities involved in biopharmaceutical manufacture.
- Critically appraise the technical, operational, regulatory and commercial aspects of manufacture.
- Work in teams to design a manufacturing project of a biological molecule.


Syllabus

The following elements will be presented and discussed with reference to Industry examples to illustrate Industry development and growth of Biopharmaceutical manufacturing.
- The requirements of Biopharmaceutical manufacturing and its role in drug development.
- Analytical method development and data to support regulatory submission.
- Upstream and downstream processing.
- Formulation, excipients, stability and monitoring methods.
- Change control, comparability assessment and process validation.
- General considerations of productivity, costs, Quality by Design, product release.

Teaching methods

Delivery typeNumberLength hoursStudent hours
presentation12.002.00
Fieldwork19.009.00
Lecture22.004.00
Lecture43.0012.00
Tutorial21.002.00
Private study hours121.00
Total Contact hours29.00
Total hours (100hr per 10 credits)150.00

Private study

Private study is required in support of both the Group Project and Oral presentation that will involve considerable individual contributions. The remaining private study is in support of widening understanding of the lecture material.

Opportunities for Formative Feedback

This will be done by working with each group during the design project meetings (tutorials). Off-site visit will provide further opportunity for monitoring progress.

Methods of assessment


Coursework
Assessment typeNotes% of formal assessment
Group ProjectSingle written report per team with individual and team components70.00
Oral PresentationGroup presentation at Panel style session. Includes Peer assessment.30.00
Total percentage (Assessment Coursework)100.00

Normally resits will be assessed by the same methodology as the first attempt, unless otherwise stated

Reading list

There is no reading list for this module

Last updated: 29/04/2022 15:27:27

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