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CHEP8003 - Biopharmaceutical Engineering

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Title:Biopharmaceutical Engineering
Long Title:Biopharmaceutical Engineering
Module Code:CHEP8003
 
Duration:1 Semester
Credits: 5
NFQ Level:Intermediate
Field of Study: Chemical & Process Eng
Valid From: Semester 1 - 2016/17 ( September 2016 )
Module Delivered in 1 programme(s)
Module Coordinator: NIALL MORRIS
Module Author: SANDRA LENIHAN
Module Description: This module increases the students understanding of complex interactions between biocatalysts and their media with particular reference to the production of biopharmaceuticals.
Learning Outcomes
On successful completion of this module the learner will be able to:
LO1 Appraise a given bioconversion and make recommendations on a suitable feeding regime and bioreactor configuration.
LO2 Appraise strategies to recover and purify products of traditional and biopharmaceutical bioprocesses.
LO3 Propose a suitable upstream and downstream system design for a high value and high molecular weight protein which is produced in low concentrations by prokaryotic or eukaryotic vectors.
LO4 Evaluate and analyse the regulatory environment in which biopharmaceutical products are developed and made available to patients.
LO5 Evaluate peer reviewed journals of relevance to biopharmaceutical production systems.
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
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.

No requirements listed
 

Module Content & Assessment

Indicative Content
Utilising genetically engineered organisms
Recap of rDNA technology, biological modification process, sources of proteins and cell machinery, selection of host type and vector systems, construct designs, protein engineering and important genes, strategies for protein optimisation. Case studies.
Upstream Processing
Media design, Water for Injection, sterilisation, up-scaling considerations, generation and maintenance of cell lines, process constraints and solutions.
Downstream Processing
Assessment of separation technologies for recovery, isolation, purification and polishing of bioproducts in terms of cost and efficiencies; centrifugation, filtration and chromatography. Case Studies.
Production of biopharmaceuticals
Classification and properties of therapeutic proteins, design process trains (upstream and downstream) for biopharmaceutical products of various value products, yields, host types and properties. Single use technologies.
Regulatory affairs
Introduction to regulatory compliance within a biopharmaceutical context (licensing/regulatory bodies such as FDA, EMEA, HPRA, etc). Overview of biotechnological issues such as viral clearance and cleaning. Quality by Design. Process Analytical Technologies.
Assessment Breakdown%
Course Work30.00%
End of Module Formal Examination70.00%
Course Work
Assessment Type Assessment Description Outcome addressed % of total Assessment Date
Project Group based project on evaluating existing Biopharmaceutical processes, incorporating suitable technologies within regulatory constraints to enhance productivity. 1,2,3,4,5 30.0 Week 9
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 70.0 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 Lecture 4.0 Every Week 4.00
Independent & Directed Learning (Non-contact) Independent Learning 3.0 Every Week 3.00
Total Hours 7.00
Total Weekly Learner Workload 7.00
Total Weekly Contact Hours 4.00
Workload: Part Time
Workload Type Workload Description Hours Frequency Average Weekly Learner Workload
Lecture Lecture 4.0 Every Week 4.00
Independent & Directed Learning (Non-contact) Independant learning 3.0 Every Week 3.00
Total Hours 7.00
Total Weekly Learner Workload 7.00
Total Weekly Contact Hours 4.00
 

Module Resources

Recommended Book Resources
  • Ganapathy Subramanian (Editor) 2012, Biopharmaceutical Production Technology, Wiley-VCH [ISBN: 9783527330294]
  • Gary Walsh 2007, Pharmaceutical Biotechnology, Concepts and Applications, Wiley [ISBN: 978-0-470-01245-1]
  • Uwe Gottschalk (ed) 2009, Process scale purification of antibodies, John Wiley & Sons Hoboken, N.J. [ISBN: 9780470209622]
  • Abhinav A. Shukla (Editor), Mark R. Etzel (Editor), Shishir Gadam (Editor) 2006, Process Scale Bioseparations for the Biopharmaceutical Industry, CRC [ISBN: 9781574445176]
  • Michael R. Ladisch 2001, Bioseparations Engineering: Principles, Practice, and Economics, Wiley [ISBN: 978-0-471-24476-9]
Supplementary Book Resources
  • Regine Eibl and Dieter Eibl, 2011, Single-Use Technology in Biopharmaceutical Manufacture, Wiley-Blackwell [ISBN: 978-0470433515]
  • 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]
  • Pauline M Doran 1995, Bioprocess Engineering Principles, 1st Ed., Academic Press [ISBN: 0-12-220856-0]
  • Michael L. Shuler & Fikret Kargi 2002, Bioprocess Engineering: Basic Engineering, 2nd Ed., Prentice Hall [ISBN: 0-13-081908-5]
  • James E. Bailey & David F. Ollis 1986, Biochemical Engineering Fundamentals, McGraw Hill [ISBN: 0-07-066601-6]
  • Colin Ratledge & Bjorn Kristiansen 2006, Basic Biotechnology, 1st Ed., Cambridge University Press [ISBN: 0-521-54958-2]
  • JF Richardson & DG Peacock 1994, Chemical Engineering Volume 3 (Chemical & Biochemical reactors and Process Control), 3rd Ed., 5, Pergamon [ISBN: 0-08-041003-0]
This module does not have any article/paper resources
This module does not have any other resources
 

Module Delivered in

Programme Code Programme Semester Delivery
CR_ECPEN_8 Bachelor of Engineering (Honours) in Chemical and Biopharmaceutical Engineering 4 Mandatory

Cork Institute of Technology
Rossa Avenue, Bishopstown, Cork

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