2021/22 Taught Postgraduate Module Catalogue
BIOL5181M Manufacturing Biopharmaceuticals
15 creditsClass Size: 33
Module manager: Dr Darren Tomlinson
Taught: Semester 1 (Sep to Jan) View Timetable
Year running 2021/22
Pre-requisite qualificationsA first degree (BSc hons) in a Biological Sciences subject, Bioprocessing or Biochemical Engineering: class 2(i) or above.
|BIOL5164M||Biopharmaceutical Development Pathway|
Module replacesBIOL5167M - Manufacturing Biopharmaceuticals
This module is not approved as an Elective
Module summaryThe 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.
ObjectivesThe 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.
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.
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.
|Delivery type||Number||Length hours||Student hours|
|Private study hours||121.00|
|Total Contact hours||29.00|
|Total hours (100hr per 10 credits)||150.00|
Private studyPrivate 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 FeedbackThis 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
|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. 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 listThere is no reading list for this module
Last updated: 30/06/2021 16:19:36
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