Module Details
| Module Code: |
BIOT7006 |
| Title: |
Biopharmaceutical Upstream
|
|
Long Title:
|
Biopharmaceutical Upstream
|
| NFQ Level: |
Intermediate |
| Valid From: |
Semester 1 - 2016/17 ( September 2016 ) |
| Field of Study: |
4218 - Biotechnology
|
| Module Description: |
This module covers the cell culture of both microbial and mammalian systems, setting it in the context of pharmaceutically bio-molecule production.
|
| Learning Outcomes |
| On successful completion of this module the learner will be able to: |
| # |
Learning Outcome Description |
| LO1 |
Evaluate the significance of biotechnology as a method for the production of pharmaceutically active substances. |
| LO2 |
Examine the key aspects of bioreactor design and contrast the various types of reactors including application, operation and limitations. |
| LO3 |
Evaluate options for media design, control and feeding regimes of cell culture systems. |
| LO4 |
Compare and contrast the key aspects of mammalian and microbial cell culture systems and their ability to express biopharmaceutical products. |
| LO5 |
Conduct, write and critically evaluate biopharmaceutical upstream based practicals. |
| Dependencies |
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 MTU module(s) it also allows for learning (in another module or modules) which is equivalent to the learning specified in the named module(s).
|
| 615 |
BIOL6014 |
Mammalian Cell Biology |
| 620 |
BIOM6002 |
Introduction to Microbiology |
| 3721 |
BIOM6008 |
Introductory Microbiology |
Incompatible Modules
These are modules which have learning outcomes that are too similar to the learning outcomes of this module. You may not earn additional credit for the same learning and therefore you may not enrol in this module if you have successfully completed any modules in the incompatible list.
|
| No incompatible modules listed |
Co-requisite Modules
|
| No Co-requisite modules listed |
Requirements
This is prior learning (or a practical skill) that is mandatory before enrolment in this module is allowed. You may not enrol on this module if you have not acquired the learning specified in this section.
|
| Biology based modules undertaken or equivalent |
| Indicative Content |
|
Overview of Biotechnological Processes
Function of antibodies and their corresponding therapeutic uses. Production of recombinant monoclonal antibodies. Production of specific biopharmaceutical products: cytokines, therapeutic proteins and peptides, antibodies and vaccines.
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Media Design and Cell Lines
Sources and validation of industrial cell lines. Cell Preservation and Cell Banking. Media design; constituents including serum and serum-free media. Preparation and sterilization. Inoculum preparation. Safety issues.
|
|
Reactor design
Bioreactor Design; basic construction, instrumentation, agitation, aeration, gas exchange and mass transfer, impellers, baffles and shear effects. Different types of bioreactors including single use disposable technologies; wavebags.
|
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Reactor Operation
Growth kinetics. Batch, fed batch and perfusion systems. Cleaning, sterilisation & contamination control. Inoculation Techniques. Sampling. Scale-up issues. Continuous processing incorporating Process Analytical Technologies.
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|
Laboratory Programme
Stirred tank reactor design and associated instrumentation - temperature, DO and pH probes, maintenance and calibration of same. Reactor preparation and sterilisation. Cell preservation, counting and viability. Growth curve collation.
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Module Content & Assessment
|
| Assessment Breakdown | % |
|---|
| Coursework | 50.00% |
| End of Module Formal Examination | 50.00% |
Assessments
| End of Module Formal Examination |
|
|
| Reassessment Requirement |
Repeat examination
Reassessment of this module will consist of a repeat examination. It is possible that there will also be a requirement to be reassessed in a coursework element.
|
The University reserves the right to alter the nature and timings of assessment
Module Workload
| Workload: Full Time |
| Workload Type |
Contact Type |
Workload Description |
Frequency |
Average Weekly Learner Workload |
Hours |
| Lecture |
Contact |
Classroom Instruction |
Every Week |
2.50 |
2.5 |
| Lab |
Contact |
Practical and report writing |
Every Second Week |
1.00 |
2 |
| Independent & Directed Learning (Non-contact) |
Non Contact |
Student study |
Every Week |
3.50 |
3.5 |
| Total Hours |
8.00 |
| Total Weekly Learner Workload |
7.00 |
| Total Weekly Contact Hours |
3.50 |
| Workload: Part Time |
| Workload Type |
Contact Type |
Workload Description |
Frequency |
Average Weekly Learner Workload |
Hours |
| Lecture |
Contact |
Classroom Instruction |
Every Week |
2.50 |
2.5 |
| Lab |
Contact |
Practicals and report writing |
Every Second Week |
1.00 |
2 |
| Independent & Directed Learning (Non-contact) |
Non Contact |
Student Study |
Every Week |
3.50 |
3.5 |
| Total Hours |
8.00 |
| Total Weekly Learner Workload |
7.00 |
| Total Weekly Contact Hours |
3.50 |
|
Module Resources
|
| Recommended Book Resources |
|---|
-
Cenk Undey, Duncan Low, Jose Monteiro Cardoso de Menezes, Mel Koch. (2012), PAT Applied in Biopharmaceutical Process Development and Manufacturing: An Enabling Tool for Quality-by-Design, 1st. CRC Press, USA, [ISBN: 9781439829455].
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Walsh, Gary. (2003), Protein Biotechnology and Biochemistry, Wiley, [ISBN: 0470843276.].
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Regine Eibl and Dieter Eibl,. (2011), Single-Use Technology in Biopharmaceutical Manufacture, 1st. Wiley and Blackwell, [ISBN: 978-0470433515].
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Brian McNeil and Linda M. Harvey. (2008), Practical fermentation technology, J. Wiley, [ISBN: 978-0-470-01434-9].
| | Supplementary Book Resources |
|---|
-
Walsh, Gary. (2001), Biopharmaceuticals: Biochemistry and Biotechnology, Wiley, [ISBN: 0471899070.].
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Crommelin H.A. & Sindelar R.D.. (2002), Pharmaceutical Biotechnology, Taylor and Francis, [ISBN: 0-415-28501-1].
-
Ganapathy Subramanian (Editor). (201), Biopharmaceutical Production Technology, Wiley-VCH, p.944, [ISBN: 9783527330294].
| | This module does not have any article/paper resources |
|---|
| Other Resources |
|---|
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Webpage, Biopharmaceutical,
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Webpage, Biopharmaceutical,
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Webpage, Parenteral Drug Association,
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