Registry
Module Specifications
Archived Version 2014 - 2015
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Description In this module, the student will be introduced to Industrial Bioprocessing and in particular to the associated areas of microbiology and animal cell culture | |||||||||||||||||||||||||||||||||||||||||
Learning Outcomes 1. Understand the steps in the industrial production of biotherapeutics made in animal cells, from gene to drug product. This involves the creation of recombinant cell lines, upstream bioprocessing (USP), downstream bioprocessing (DSP) and fill-finish operations including formulation 2. Understand the regulatory framework under which the industry operates, and the necessary analytics & quality control assays necessary to ensure product quality and batch release. 3. Use case studies to demonstrate how the drug is manufactured and the main companies engaged in biotherapeutic bioprocessing. 4. Identify the role of microbes in Industrial Bioprocessing 5. Appreciate best practice in working with microorganisms including GMOs 6. Choose suitable methodology for the detection and identification of microbes | |||||||||||||||||||||||||||||||||||||||||
All module information is indicative and subject to change. For further information,students are advised to refer to the University's Marks and Standards and Programme Specific Regulations at: http://www.dcu.ie/registry/examinations/index.shtml |
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Indicative Content and
Learning Activities Microbes in industryThe role of microbes in industry Sourcing microorganisms Maintenance and preservation of microbial culturesWorking with microorganismsClassification of microorganisms based on safety Safe handling/Containment options GMOs and regulatory authoritiesMethods for detecting and identifying microorganismsCulturability Molecular techniques Chemical techniquesWater qualityWater quality control - microbial consideration Water for pharmaceutical processes BiofilmsMicrobial BioprocessesInoculum preparation A pharmaceutical process (microbial fermentation) Brewing and/or cheesemakingAnimal cell cultureIntroduction to Animal Cell Bioprocessing, Recombinant Proteins & Biotherapeutics, Cell lines & Selection Systems, Genomics & ProteomicsBioprocessingUpstream Bioprocessing & Bioreactors Parts 1 and 2, Downstream Bioprocessing & Protein Purification Parts 1 and 2 Fill-finish & Formulation OperationsRegulationRegulatory Affairs Parts 1 and 2AnalysisProtein Assays Protein Characterization by Mass Spectrometry Bioassays Immunoassays & Case Studies | |||||||||||||||||||||||||||||||||||||||||
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Indicative Reading List
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Other Resources None | |||||||||||||||||||||||||||||||||||||||||
Programme or List of Programmes | |||||||||||||||||||||||||||||||||||||||||
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