BIOT7006: Biopharmaceutical Upstream

Title: Biopharmaceutical Upstream APPROVED

Long Title: Biopharmaceutical Upstream

Module Code: BIOT7006 Duration: 1 Semester

Credits: 5

NFQ Level: Intermediate

Field of Study: Biotechnology

Valid From: Semester 1 - 2016/17 ( September 2016 )

Module Delivered 6 programme(s)

in

Module NIALL MORRIS

Coordinator:

Module Author: SANDRA LENIHAN

Module This module covers the cell culture of both microbial and mammalian systems, setting it
Description: in the context of pharmaceutically bio-molecule production.

Learning Outcomes
On successful completion of this module the learner will be able to:
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.

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).

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

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 BIOT7006: Biopharmaceutical Upstream

Module Content & Assessment

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.
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.
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.
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.

Assessment Breakdown %
Course Work 50.00%
End of Module Formal Examination 50.00%

Course Work
Assessment Type Assessment Description Outcome % Assessment
addressed of Date
total
Practical/Skills Laboratory practicals and reports 2,3,4,5 30.0 Every Second
Evaluation Week
Short Answer Overview of BioPharma Industry. Media 1,2,3 20.0 Week 6
Questions Design and Cell Lines. Bioreactor Design

End of Module Formal Examination

Assessment Type Assessment Description Outcome % of Assessment
addressed total 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

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 BIOT7006: Biopharmaceutical Upstream

Module Workload

Workload: Full Time

Workload Type Workload Description Hours Frequency Average
Weekly
Learner
Workload
Lecture Classroom Instruction 2.5 Every 2.50
Week
Lab Practical and report writing 2.0 Every 1.00
Second
Week
Independent & Directed Student study 3.5 Every 3.50
Learning (Non-contact) Week
Total Hours 8.00
Total Weekly Learner Workload 7.00
Total Weekly Contact Hours 3.50

Workload: Part Time

Workload Type Workload Description Hours Frequency Average
Weekly
Learner
Workload
Lecture Classroom Instruction 2.5 Every 2.50
Week
Lab Practicals and report writing 2.0 Every 1.00
Second
Week
Independent & Directed Student Study 3.5 Every 3.50
Learning (Non-contact) Week
Total Hours 8.00
Total Weekly Learner Workload 7.00
Total Weekly Contact Hours 3.50

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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 Ed., CRC Press USA [ISBN: 9781439829455]
Walsh, Gary 2003, Protein Biotechnology and Biochemistry, Wiley [ISBN: 0470843276.]
Regine Eibl and Dieter Eibl, 2011, Single-Use Technology in Biopharmaceutical Manufacture, 1st
Ed., Wiley and Blackwell [ISBN: 978-0470433515]
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.]
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
[ISBN: 9783527330294]

This module does not have any article/paper resources

Other Resources

Webpage: Biopharmaceutical
http://www.bioinfo.com
Webpage: Biopharmaceutical
http://www.bio.org
Webpage: Parenteral Drug Association
http://www.pda.org

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Module Delivered in

Programme Programme Semester Delivery

Code
CR_SCHQA_8 Bachelor of Science (Honours) in Analytical Chemistry with 5 Elective
Quality Assurance
CR_SINEN_8 Bachelor of Science (Honours) in Instrument Engineering 5 Elective
CR_SCHEM_7 Bachelor of Science in Analytical and Pharmaceutical 5 Elective
Chemistry
CR_SPHYS_7 Bachelor of Science in Applied Physics and Instrumentation 5 Elective
CR_SGMPR_7 Bachelor of Science in Good Manufacturing Practice and 1 Elective
Technology
CR_EBIPR_7 Certificate in Biopharmaceutical Processing 1 Mandatory

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