UCD School of Chemical & Bioprocess Engineering
Scoil na hInnealtóireachta Ceimicí agus Bithphróisis UCD
Structure of the Programme
The course content is outlined in the following Table.
| Module Title | ||
|---|---|---|
| Principles of Biopharmaceutical Engineering | ||
| Transport Phenomena | ||
| Biochemist's Toolkit | ||
| Molecular Genetics & Biotechnology | ||
| Animal Cell Culture Technology | ||
| Microbial Cell Factory | ||
| Bioreactor Modelling & Control | ||
| Bioseparations | ||
| Bioprocessing Laboratory Practice | ||
| Regulatory Affairs Science for Biotechnology Products | ||
| Formulation and Delivery of Biopharmaceuticals | ||
| Facility Design & Operation | ||
| Biopharmaceutical Industry Regulation & Management | ||
| Bioprocess Scale-up & Technology Transfer | ||
| Research/Design Project |
CHEN40020 Introduction to Biopharmaceutical Engineering
This module will provide an introduction to the important principles and techniques that are used in the design and analysis of biopharmaceutical engineering processes. It will also develop students' knowledge and understanding of industrial processing, analytical abilities and problem solving methodologies in this area.
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CHEN40030 Fundamentals of Bioreaction Processes
The aim of this module is to introduce students to the multi-disciplinary nature of biotechnology and how bioprocesses are planned, organised and how they develop from basic cell structure and function through bioreactor to DSP. The objective is to enable a comprehension of both the concepts and language of biotechnology, to enable communication between people working in the different stages of a bioprocess, from management to form and filling.
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CHEN40040 Animal Cell Culture Technology
This module aims to extend student's understanding of structure, function and behaviour of animal cells in vitro culture and to explain their usefulness for industrial and medical purpose. Topics at the forefront of the subject are described, including cell line development, cell banking and cell characterisation, cell growth and death, cell physiology and techniques used in both industry and research laboratories used for the production of recombinant proteins and other commercial uses of animal cells. It also provides an understanding of the requirements of animal cell processes for containment and asepsis.
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CHEN40050 Recombinant DNA Technology
This module aims to provide the student with the relevant background information necessary to understand how proteins of interest (in particular, biopharmaceuticals) can be produced safely, stably and authentically, on a large scale, using an appropriate cell-based system.
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CHEN40060 Modelling, Simulation, Prediction and Control of Bioprocesses in Bioreactors
The aim of this module is to teach the use of modelling and simulation as an aid to the understanding of biochemical engineering processes and their dynamics. The module will provide and foster students understanding of the complex interactions between the reaction conditions seen in practical bioreactors and the physiological responses expressed by microbial cells. It is based on the hands-on use of the computer as an integral part of the learning process via a combination of basic modelling theory and examples. The examples are based on the use of SIMULINK (an extension to MATLAB that allow rapid and accurate build-up of computer models of dynamic systems using block diagram notation). Using SIMULINK, it is easy to predict complex non-linear systems, producing graphical animations that show the progress of a simulation visually. Dynamic simulation aims in gaining a better understanding of bioprocess performance and is a powerful tool for plant optimisation and control; it is equally important in large scale continuous process operations as well as in batch and fed-batch manufacturing processes.
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CHEN40220 Regulatory Affairs Science for Biotechnology Products
The module is intended to introduce the regulatory context in which medicinal products, particularly those produced through biotechnology processes, are developed and made available to patients. The module sets out to explain and develop the working interface between science, technology, manufacturing processes and the licensing/ regulatory environment which controls medicines. The global organisation of relevant regulation is outlined, particularly the roles of ICH, CFR and EU. Due emphasis is placed on issues related to establishment of quality standards for biotechnology derived products as well as required information on safety and efficacy as appropriate. There are obvious interrelationships and connections to other NIBRT modules eg GMP, material characterisation, formulation and analytical technologies and methodologies. These are not repetitive treatments of the same subject but a necessary distinction to accommodate difference in depth in specific areas eg characterisation and stability in a second treatment. The module will also address regulatory issues surrounding gene therapies, DNA vaccines, cell therapies and Biosimilars.
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CHEN40080 Bioseparations
The aim of this module is to provide a detailed understanding of the behaviour of proteins in solution and how their properties may be altered by changing the physical surroundings. To provide an understanding of the theory and practical techniques involved in developing a purification process.
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CHEN40090 Bioprocessing Laboratory
The module will introduce students to laboratory procedures associated with bioprocesses. In particular student will culture cells at laboratory scale in shake flasks and spinner flasks. Growth and productivity of cells will be monitored and measured using standard assay techniques. Basic product purification techniques will also be demonstrated.
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CHEN40130 Bioprocess Scale-up and Technology Transfer
This module will provide an overview of the regulatory, technical and management issues associated with the scale-up and transfer of industrial bioprocesses. The focus will be on giving a clear understanding of the technical/regulatory requirements and approaches necessary to obtain regulatory approval for product scale-up and transfer. It will provide guidance on how to implement efficient/effective projects and will also address such areas as process validation and the typical costs associated with these projects.
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CHEN40110 Facility Design & Operation
This module will provide an overview of the technical and managerial challenges associated with the design and construction of a biopharmaceutical manufacturing facility. It will address all the major elements of these projects from site master planning through conceptual and detailed design and onto commissioning and qualification. It will also cover such associated project aspects as overall planning, budgeting and the organisational systems and structures required to successfully execute such major investments. An overview of how biopharmaceutical manufacturing facilities operate will also be addressed so as the design of the facility from the material and personnel flows through to the process controls and automation, meet the needs of the operations personnel after the facility is brought into production.
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CHEN40230 Formulation and Delivery of Biopharmaceuticals
The increasing number of advanced biopharmaceuticals demands novel methods of formulation of effective and stable drug delivery systems, since most of them cannot be manufactured as simple oral dosage forms (ie, tablets). Novel routes of, preferably non-invasive, delivery into the human body will be discussed as well as concepts in design and characterisation of modern drug delivery systems.
CHEN40120 Biopharmaceutical Industry Regulation and Management
This module will provide a high level overview of the regulatory environment and the roles and responsibilities in which biopharmaceutical engineering professionals must operate. The focus will be on the current good manufacturing practices (cGMP) associated with the manufacture of biological medicinal products for human use. Emphasis will be on harmonised requirements common to the various international regulatory authorities. These cGMPs will address the principles, premises, equipment, documentation, production, and quality-control aspects of biopharmaceutical manufacturing.
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CHEN40240 Research Project
CHEN40250 Design Project
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