Module Details
Module Code: |
BITC S7012 |
Full Title:
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Pharmaceutical Biotechnology
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Valid From:: |
Semester 1 - 2019/20 ( June 2019 ) |
Language of Instruction: | English |
Module Owner:: |
Caroline Gilleran
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Module Description: |
The aims of this module are to explore how biological organisms (including genetically modified organisms) are involved in the production and manufacture of pharmaceuticals.
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Module Learning Outcome |
On successful completion of this module the learner will be able to: |
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Module Learning Outcome Description |
MLO1 |
Explain the molecular methods used to create Genetically Modified Organisms and evaluate the merits of different
expression systems for the production of recombinant proteins. |
MLO2 |
Describe how Genetically Modified Organisms can be cultured on a large scale and are used in the production of
recombinant proteins and pharmaceuticals. |
MLO3 |
Examine and evaluate protein stability and the fundamental principles, operating criteria and design options for
downstream processing operations. |
MLO4 |
Interpret the regulatory and safety issues regarding application of recombinant biological systems in industry. |
MLO5 |
Apply practical competence in selected molecular and biotechnological techniques. |
Pre-requisite learning |
Module Recommendations
This is prior learning (or a practical skill) that is strongly recommended before enrolment in this module. You may enrol in this module if you have not acquired the recommended learning but you will have considerable difficulty in passing (i.e. achieving the learning outcomes of) the module. While the prior learning is expressed as named DkIT module(s) it also allows for learning (in another module or modules) which is equivalent to the learning specified in the named module(s).
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No recommendations listed |
Module Indicative Content |
Fundamentals of Pharmaceutical Biotechnology
Molecular technologies to manipulate genomes and to express heterologous proteins.
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Bioprocessing
Modes of fermentation, bioreactor types, process control, scale-up.
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Production of pharmaceutical products using recombinant systems
Production of recombinant proteins using bacterial, yeast, insect cells, mammalian cells, plant and animal systems.
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Protein purification
Design and evaluation of protein purification strategies. Protein extraction techniques, protein concentration techniques, protein
separation techniques and electrophoretic analysis.
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Protein stability
Protein denaturation and inactivation processes. Strategies to improve stability - fusion proteins, use of excipients, recombinant
approaches.
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Regulation
Regulatory and safety issues associated with the use of recombinant microbes in industry
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Sample practicals
Yeast fermentation. Production of industrial biocatalysts using recombinant bacteria. GFP expression and purification. SDS-PAGE.
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Module Assessment
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Assessment Breakdown | % |
Practical | 50.00% |
Final Examination | 50.00% |
Module Special Regulation |
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AssessmentsFull Time On Campus
DKIT reserves the right to alter the nature and timings of assessment
Module Workload
Workload: Full Time On Campus |
Workload Type |
Contact Type |
Workload Description |
Frequency |
Average Weekly Learner Workload |
Hours |
Lecture |
Contact |
lecture |
Every Week |
3.00 |
3 |
Practical |
Contact |
Practical class |
Every Week |
3.00 |
3 |
Independent Study |
Non Contact |
Independent study |
Every Week |
5.00 |
5 |
Directed Reading |
Non Contact |
Supplementary reading material will be posted on moodle. |
Every Week |
1.00 |
1 |
Total Weekly Learner Workload |
12.00 |
Total Weekly Contact Hours |
6.00 |
This module has no Part Time On Campus workload. |
Module Resources
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Recommended Book Resources |
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D.P. Clark and N.J. Pazdernik. (2012), Biotechnology, Update. Elsevier/Academic, Amsterdam.
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S. Denyer, N.A. Hodges and S.P. Gorman. (2011), Hugo and Russell’s Pharmaceutical Microbiology, 8th. Wiley-Blackwell.
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G. Walsh. (2013), Biopharmaceuticals: Biochemistry and biotechnology, 2nd. Wiley-Blackwell.
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G. Walsh. (2013), Pharmaceutical Biotechnology: Concepts and Applications, 1st. Wiley-Blackwell.
| Supplementary Book Resources |
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Madigan et al.. (2011), Brock Biology of Microorganisms, 13th. Pearson education.
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L.M. Prescott. (2005), Microbiology, McGraw-Hill.
| Recommended Article/Paper Resources |
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N. Ferrer-Miralles, J. Domingo-Espin,
J.L. Corchero, E. Vazquez, A. Villaverde. (2009), Microbial factories for recombinant
pharmaceuticals, Microbial Cell Factories, 8 (17), p.1-8.
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Demain, A., Vaishnav, P.. (2009), Production of recombinant proteins by
microbes and higher organisms, Biotechnology Advances, 27 (3), p.297.
| Other Resources |
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Website, United States Food and Drug
Administration,
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Website, European Biopharmaceutical Enterprises,,
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Website, EU database,
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Website, British Pharmacopoeia,
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Journal search database, Science Direct,
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Journal search database, Entrez PubMed,,
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