Module Details
Module Code: |
PHAR S8022 |
Full Title:
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Bioprocessing
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Valid From:: |
Semester 1 - 2020/21 ( September 2020 ) |
Language of Instruction: | English |
Module Owner:: |
annamarie rogers
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Departments: |
Life and Health Sciences
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Module Description: |
The aim of the module is to provide students with an in-depth knowledge of the upstream and downstream processing of biopharmaceuticals (both theoretical pertained to the development, production and purification of biopharmaceuticals).
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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 |
Critique the choice of expression systems used for the production of recombinant proteins. |
MLO2 |
Evaluate how plasmid vectors can be modified and utilised to produce high, and sustainable, production levels of recombinant biopharmaceuticals. |
MLO3 |
Critique how Genetically Modified Organisms can be cultured on a large scale in a bioreactor to maximize their growth and formation of product. |
MLO4 |
Evaluate different chromatography and electrophoretic techniques in downstream processing for optimal purification for recombinant proteins. |
MLO5 |
Appraise filtration systems for recovery, purification, concentration and final polishing of biopharmaceuticals and viral clearance. |
MLO6 |
Characterise finished biopharmaceutical products. |
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 |
COURSE CONTENT Upstream Processing
n/a
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Expression Systems
Evaluation of different expression systems (bacteria, yeast, insect, plant, mammalian). Selecting a gene and designing a vector for recombinant protein production. Experimental approaches for expression system transfection (viral vectors, plasmids, calcium phosphate transfection, heat shock, electroporation).
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Cell culture and aseptic technique
Nutritional requirements of mammalian cells: growth media preparation, sterilisation and quality control. Adherent vs suspension cells. Generation of cell banks. Sub-culturing and cryopreservation techniques. Methods for monitoring the growth and viability of mammalian cells. Aseptic requirements for cell culture: sources of contamination, processes and techniques involved in maintaining culture sterility.
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Cell culture control
Monitoring / optimisation of expression system growth and product formation (pH, temperature, dissolved O2, nutrients, agitation, biomass, contamination, protein stability).
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Cell growth equipment (small & large scale)
Selection of appropriate bioreactor configuration (bioreactor, continuous stirred tank reactor, airlift reactor, bubble reactor, trickle bed reactor). Evaluation of cell culture configuration for specific biopharmaceutical products (batch culture, fed-batch, continuous culture, perfusion culture, cell immobilisation strategies).
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COURSE CONTENT Downstream Processing
n/a
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Capture & Harvest
Compare and contrast methods for intracellular and extracellular biopharmaceutical recovery - cell disruption (physico-mechanical and chemical), centrifugation (disk stack centrifuge), filtration (normal flow filtration (NFF), tangential flow filtration (TFF), single path TFF).
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Chromatography
Evaluate chromatographic techniques for recombinant protein separation and purification (Protein A affinity, ion exchange, hydrophobic interaction and size exclusion).
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Filtration
Compare and contrast filtration systems for product concentration & buffer exchange (Ultra/Diafiltration). Integrity testing of filters. Evaluate filtration systems for viral inactivation & final polishing - NF versus TFF. Viral inactivation and removal.
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Fill finish
Methods for aqueous and freeze dried products. Vial filling, stoppering, capping, labelling & packaging. Depyrogenation.
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Protein characterisation
Characterisation of finished biopharmaceutical products - in-process and final product testing. Detection and determination of yield, purity, concentration and biological activity.
Electrophoretic methods (SDS-PAGE, UV spectroscopy, protein assays).
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NIBRT Training
Students will gain theoretical knowledge and practical experience in a range of upstream and downstream biopharmaceutical techniques (eg cell culture, filtration, chromatography) in an Industrial setting.
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Module Assessment
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Assessment Breakdown | % |
Course Work | 10.00% |
Practical | 40.00% |
Final Examination | 50.00% |
Module Special Regulation |
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AssessmentsPart-time
Reassessment Requirement |
A 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.
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DKIT reserves the right to alter the nature and timings of assessment
Module Workload
This module has no Full-time workload. |
Workload: Part-time |
Workload Type |
Contact Type |
Workload Description |
Frequency |
Average Weekly Learner Workload |
Hours |
Lecture |
Contact |
2 x 1 hour lectures |
Every Week |
2.00 |
2 |
Practical |
Contact |
2 x 4 hour practical at end of semester |
Once per semester |
0.53 |
8 |
Practical |
Contact |
1 day training in NIBRT |
Once per semester |
0.53 |
8 |
Directed Reading |
Non Contact |
Notes / Paper / Textbook reading |
Every Week |
2.00 |
2 |
Independent Study |
Non Contact |
Self / group study |
Every Week |
5.00 |
5 |
Total Weekly Learner Workload |
10.07 |
Total Weekly Contact Hours |
3.07 |
Module Resources
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Recommended Book Resources |
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Michael Butler. (2007), Cell Culture and Upstream Processing, Taylor and Francis Group, Available on the DkIT NetLibrary collection.
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William Whyte. (2010), Cleanroom Technology: Fundamentals of Design, Testing and Operation, 2nd. Wiley.
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John M. Davis. (2011), Animal Cell Culture: Essential Methods, 1. Wiley.
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Walls and Loughran. (2011), Protein Chromatography “Methods and Protocols", Humana Press, [ISBN: ISBN:9781607].
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Pauline M. Doran. (2012), Bioprocess Engineering Principles, 2. Academic Press.
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Walsh, G.. (2013), Biopharmaceuticals: Biochemistry and biotechnology, 2nd. J. Wiley and Sons.
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Shijie Liu. (2016), Bioprocess Engineering : Kinetics, Biosystems, Sustainability, and Reactor Design, 2. Elsevier.
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Gunter Jagschies, Eva Lindskog, et al. (2017), Biopharmaceutical Processing: Development, Design, and Implementation of Manufacturing Processes., Elsevier, [ISBN: 978-008100623].
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Damian J. Houde. (2019), Biophysical Characterization of Proteins in Developing Biopharmaceuticals, Elsevier, [ISBN: 978-044464173].
| Supplementary Book Resources |
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R. Ian Freshney. (2011), Culture of Animal Cells: A Manual of Basic Technique and Specialized Applications, 6. Wiley-Blackwell.
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Ganapathy Subramanian. (2012), Biopharmaceutical Production Technology, Wiley.
| This module does not have any article/paper resources |
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Other Resources |
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Textbook collection online with DkIT, 'Access online textbooks through DkIT's
eBook collection (go to DkiT library
site to begin)'.
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website, Biopharm International,
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website, Science Break-throughs: www.breebio.com.
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website, American tissue culture collection
http://www.atcc.com.
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website, European Directorate for the Quality of
Medicines and Healthcare
http://www.edqm.eu.
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website, European Medicines Agency
http://www.ema.europa.eu/ema/.
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website, International Conference on
Harmonisation of Technical Requirements
for Registration of Pharmaceuticals for
Human Use (ICH) http://www.ich.org/.
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website, HPRA http://www.hpra.ie/.
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website, 'U.S. Food and Drug Administration
http://www.fda.gov'.
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website, The National Institute for Bioprocessing
Research and Training (NIBRT):
www.nibrt.ie.
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website, Bioconnect Ireland:
www.biotechnologyireland.com.
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