2024/25 Taught Postgraduate Module Catalogue

BIOL5181M Manufacturing Biopharmaceuticals

15 creditsClass Size: 40

Module manager: Dr Dimitra Mitsa
Email: D.Mitsa@leeds.ac.uk

Taught: Semester 1 (Sep to Jan) View Timetable

Year running 2024/25

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

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:
1. Describe the range of activities involved in biopharmaceutical manufacture.
2. Critically appraise the technical, operational, regulatory and commercial aspects of manufacture.
3. 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 type	Number	Length hours	Student hours
presentation	1	4.00	4.00
Fieldwork	1	9.00	9.00
Lecture	6	3.00	18.00
Tutorial	1	1.00	1.00
Tutorial	1	2.00	2.00
Private study hours			116.00
Total Contact hours			34.00
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

The two tutorials are used to guide and advise students for the two assignments required in the module. The students are split into groups during the tutorials and various aspects of the assignments are discussed.

Methods of assessment

Coursework

Assessment type	Notes	% of formal assessment
Group Project	Single written report per team with individual and team components	70.00
Oral Presentation	Group presentation at Panel style session. Individual as well as group contribution components	30.00
Total percentage (Assessment Coursework)		100.00

Resits for the group project and presentation will include an alternative piece of individual coursework.

Reading list

There is no reading list for this module

Last updated: 31/07/2024

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