Aims and Fit of Module
This module aims to provide an understanding of the key equipment and unit operations used in manufacturing biopharmaceutical products, including vaccines, therapeutic proteins, and cell/gene therapies. The module will cover fermentation, extraction technologies and purification operations, describe the design and application of each unit of operations, and introduce key associated topics including process engineering, analytical technologies, automation, quality by design, and regulatory issues. The module will, in particular, focus on the latest industrial trends, and current and future challenges in biopharmaceutical manufacturing.
A Understand industry biotechnology unit operations such as fermentation, cell culture, bioreactor design, production and purification process development, scale-up, and manufacturing.
B Demonstrate a good understanding of the core design principles and tools that underpin engineering of genetic vectors, cells and biopharmaceutical products (i.e., proteins, vaccines, gene therapeutics), including Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP).
C Understand bioproduction process design and optimization.
D Demonstrate an understanding of process control fundamentals when applied to the growth of mammalian cells or bacterial fermentation in bioreactors.
E Understand the scientific principles involved in the development of a biopharmaceutical production process.
F Demonstrate the ability to work as part of a design team for the development of a new production facility.
G Understand the engineering principles underlying the production of biopharmaceuticals.
H Demonstrate integrated knowledge of regulatory issues related to biopharmaceutical production.
I Evaluate and select the advanced biodevice and equipment.
Method of teaching and learning
Key topics will be introduced through standard lectures, supported by materials on the web-based resources. Tutorials in each week will enable the students to review the teachings in the lectures. Animations and/or videos will be shown for some of the topics. Review sessions will be arranged towards end of the semester and the students will have opportunities to self-assess their understanding of the course.
Students will attend a 2-hour lecture and a 1-hour tutorial per week. A two-day industry site visit was designed to give students an on-site understanding about the bioproduction process design, facility development and optimization. Additionally, practical demonstrations and workshops will aid learning. Students will be guided to key articles in the literature (original papers and review articles) and be expected to use this material to supplement their independent learning. A key principle of this module will be the understanding and application of techniques in Biopharmaceutical Equipment and Engineering Design. At non-regular intervals, formative assessment (questions, coursework, quiz, presentation, or group discussion) will be delivered to get the teaching feedback. Summative assessment exercises (coursework, visit report, and exams) will test knowledge and ability to solve problems at a regular interval.