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BIOT7005 - Biopharmaceutical Downstream

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Title:Biopharmaceutical Downstream
Long Title:Biopharmaceutical Downstream
Module Code:BIOT7005
 
Duration:1 Semester
Credits: 5
NFQ Level:Intermediate
Field of Study: Biotechnology
Valid From: Semester 1 - 2016/17 ( September 2016 )
Module Delivered in 2 programme(s)
Module Coordinator: NIALL MORRIS
Module Author: SANDRA LENIHAN
Module Description: Biopharmaceutical Downstream Processing covers the unit processes commonly used for separating and purifying proteins, recombinant DNA products and monoclonal antibodies.
Learning Outcomes
On successful completion of this module the learner will be able to:
LO1 Explain the properties of proteins that are exploited for separation and purification purposes.
LO2 Elaborate on the theoretical principles of a range of capture, concentration and purification unit operations including any limitations in their use.
LO3 Justify the key quality/ purity requirements for Biopharmaceuticals products.
LO4 Evaluate the issues associated with the scale up of downstream unit operations and apply appropriate problem solving approaches.
LO5 Conduct and critically report on a range of downstream processing unit operations.
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 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).

Mammalian Cell Biology level 6 or equivalent, Introduction to Microbiology level 6 or equivalent.
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.

None
 

Module Content & Assessment

Indicative Content
Proteins
Proteins structure, fragility and properties exploited in separation and purification.
Downstream Unit Operations
Developing downstream purification strategies. Theory of cell disruption methods. Harvesting of cells; centrifugation and filtration. Protein purification methods. Chromatographic techniques; Gel filtration, affinity, ion exchange and hydrophobic. Novel separation techniques. Filtration; depth and crossflow. Protein concentration; Diafiltration. Membrane characteristics. Removal of DNA, prions, viral and pyrogen contamination.
Quality Assurance
Sampling, Protein identification and Purity – ICH guidelines /FDA perspective (e.g. endotoxin, viral clearance tests etc).
Scale-up and optimisation
Chromatography; packing, operation, resin storage and regeneration, cleaning and sanitisation. Buffer preparation and exchange. Scale-up of purification systems. Process yields. Waste management. Single use disposable technologies. Process Analytical Technologies.
Laboratory Programme
Cell disruption. Centrifugation. Anion exchange chromatograpy. Gel Filtration and column packing. Buffer exchange. Desalting of proteins using Diafiltration.
Assessment Breakdown%
Course Work50.00%
End of Module Formal Examination50.00%
Course Work
Assessment Type Assessment Description Outcome addressed % of total Assessment Date
Short Answer Questions Written Examination on Proteins, Downstream Unit Operations and Quality Assurance 1,2,3 20.0 Week 7
Practical/Skills Evaluation Labs and report writing 1,2,5 30.0 Every Second Week
End of Module Formal Examination
Assessment Type Assessment Description Outcome addressed % of total Assessment Date
Formal Exam End-of-Semester Final Examination 1,2,3,4 50.0 End-of-Semester
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 institute reserves the right to alter the nature and timings of assessment

 

Module Workload

Workload: Full Time
Workload Type Workload Description Hours Frequency Average Weekly Learner Workload
Lecture Class room instruction 2.0 Every Week 2.00
Lab Laboratory Practicals 2.0 Every Second Week 1.00
Independent & Directed Learning (Non-contact) Student Study 4.0 Every Week 4.00
Total Hours 8.00
Total Weekly Learner Workload 7.00
Total Weekly Contact Hours 3.00
Workload: Part Time
Workload Type Workload Description Hours Frequency Average Weekly Learner Workload
Lecture Classroom Instruction 2.0 Every Week 2.00
Lab Laboratory Practicals 2.0 Every Second Week 1.00
Independent & Directed Learning (Non-contact) Student Study 4.0 Every Week 4.00
Total Hours 8.00
Total Weekly Learner Workload 7.00
Total Weekly Contact Hours 3.00
 

Module Resources

Recommended Book Resources
  • Cenk Undey, Duncan Low, Jose Monteiro Cardoso de Menezes and Mel Koch (ed) 2012, PAT Applied in Biopharmaceutical Process Development and Manufacturing: An Enabling Tool for Quality-by-Design, CRC Press USA [ISBN: 9781439829455]
  • Walsh, Gary 2003, Protein Biotechnology and Biochemistry, Wiley [ISBN: 0470843276.]
  • Regine Eibl, Dieter Eibl, 2011, Single-Use Technology in Biopharmaceutical Manufacture, 1st Edition Ed., Wiley - Blackwell [ISBN: 978-0470433515]
  • Abhinav A. Shukla (Editor), Mark R. Etzel (Editor), Shishir Gadam (Editor) 2006, Process Scale Bioseparations for the Biopharmaceutical Industry, CRC [ISBN: 9781574445176]
Supplementary Book Resources
  • Crommelin H.A. & Sindelar R.D. 2002, Pharmaceutical Biotechnology, Crommelin H.A. & Sindelar R.D. [ISBN: 0-415-28501-1]
  • Walsh, Gary 2001, Biopharmaceuticals: Biochemistry and Biotechnology, Wiley [ISBN: 0471899070.]
  • Colin Ratledge and Bjørn Kristiansen (ed) 2006, Basic biotechnology, Cambridge University Press [ISBN: 0521549582]
  • Roshni L. Dutton and Jeno M. Scharer (ed) 2007, Advanced technologies in biopharmaceutical processing, Blackwell Pub. Ames, Iowa [ISBN: 978-0-8138-0517-7]
  • Uwe Gottschalk (Ed) 2009, Process scale purification of antibodies, John Wiley & Sons Hoboken, N.J. [ISBN: 9780470209622]
  • Ganapathy Subramanian (Editor) 2012, Biopharmaceutical Production Technology, Wiley-VCH [ISBN: 9783527330294]
This module does not have any article/paper resources
Other Resources
 

Module Delivered in

Programme Code Programme Semester Delivery
CR_SGMPR_7 Bachelor of Science in Good Manufacturing Practice and Technology 2 Elective
CR_EBIPR_7 Certificate in Biopharmaceutical Processing 2 Mandatory

Cork Institute of Technology
Rossa Avenue, Bishopstown, Cork

Tel: 021-4326100     Fax: 021-4545343
Email: help@cit.edu.ie