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BIOT7014 - Downstream Bioprocessing

Title:Downstream Bioprocessing
Long Title:Downstream Bioprocessing
Module Code:BIOT7014
Duration:1 Semester
Credits: 5
NFQ Level:Intermediate
Field of Study: Biotechnology
Valid From: Semester 1 - 2017/18 ( September 2017 )
Module Delivered in 1 programme(s)
Module Coordinator: Brigid Lucey
Module Author: Rosemary Rea
Module Description: This module is designed to familarise students with the downstream processing of recombinant biopharmaceutical products.
Learning Outcomes
On successful completion of this module the learner will be able to:
LO1 Provide an overview of a typical biopharmaceutical downstream process.
LO2 Outline the properties of Bioproducts utilised for purification.
LO3 Describe the main stages of downstream processing operations.
LO4 Discuss the role of clean rooms in the manufacturing facility.
LO5 Perform experimental tasks related to downstream processing.
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 CIT module(s) it also allows for learning (in another module or modules) which is equivalent to the learning specified in the named module(s).
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

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.

No requirements listed

Module Content & Assessment

Indicative Content
Biopharmaceutical downstream process.
Overview of a typical downstream process for biopharmaceuticals. Differences between manufacturing processes for pharmaceuticals and biopharmaceuticals. Generic drugs and biosimilars.
Bioproducts and Contamination
A description of the physical and chemical properties of proteins exploited in purification. DNA, microbial, viral and endotoxin contamination of bioproducts.
Downstream Processing Operations
Harvesting of cells, disruption of cells, product isolation, centrifugation, filtration and protein purification. Removal of DNA, viral and pyrogenic contamination. Formulation of bioactive compounds. Analytical testing requirements. Packaging and labelling of recombinant biopharmaceutical products. Water purity requirements.
Manufacturing Facilities and Clean Rooms
The role of clean rooms in maintaining sterility. Clean room classification, gowning, cleaning, deconatmination and sanitisation. Environmental monitoring of clean rooms. Overview of regulations.
Laboratory Programme
Conduct relevant laboratory procedures and practical skills.
Assessment Breakdown%
Course Work100.00%
Course Work
Assessment Type Assessment Description Outcome addressed % of total Assessment Date
Other Theory based assessment 1,2,3 35.0 Week 6
Other Theory based assessment 3,4 35.0 Week 12
Practical/Skills Evaluation Laboratory practicals and report writing 3,5 30.0 Every Week
No 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 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 Classroom Instruction 2.0 Every Week 2.00
Lab Laboratory Practicals 2.0 Every Week 2.00
Independent & Directed Learning (Non-contact) Self-Directed Study 3.0 Every Week 3.00
Total Hours 7.00
Total Weekly Learner Workload 7.00
Total Weekly Contact Hours 4.00
This module has no Part Time workload.

Module Resources

Recommended Book Resources
  • Michael C. Flickinger 2013, Downstream Industrial Biotechnology: Recovery and Purification, J. Wiley [ISBN: 9781118131244]
Supplementary Book Resources
  • Gary Walsh 2007, Pharmaceutical Biotechnology: Concepts and Applications, J. Wiley [ISBN: 9780470012444]
  • Roshni L. Dutton and Jeno M. Scharer 2007, Advanced technologies in biopharmaceutical processing, Blackwell Pub. [ISBN: 978-0-8138-0517-7]
This module does not have any article/paper resources
Other Resources

Module Delivered in

Programme Code Programme Semester Delivery
CR_SPHBI_8 Bachelor of Science (Honours) in Pharmaceutical Biotechnology 5 Mandatory

Cork Institute of Technology
Rossa Avenue, Bishopstown, Cork

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