Registry

Module Specifications

Archived Version 2014 - 2015

Module Title	Industrial Bioprocessing
Module Code	BE401
School	School of Biotechnology
Online Module Resources
Module Co-ordinator	Dr Brid Quilty	Office Number	X208
NFQ level	8	Credit Rating	5
Pre-requisite	None
Co-requisite	None
Compatibles	None
Incompatibles	None

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

*Type*	*Hours*	*Description*
Workload	Full-time hours per semester
Lecture	30	No Description
Tutorial	2	No Description
Independent Study	93	No Description
Total Workload: 125

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

Indicative Content and Learning Activities

Microbes in industry
The role of microbes in industry Sourcing microorganisms Maintenance and preservation of microbial cultures

Working with microorganisms
Classification of microorganisms based on safety Safe handling/Containment options GMOs and regulatory authorities

Methods for detecting and identifying microorganisms
Culturability Molecular techniques Chemical techniques

Water quality
Water quality control - microbial consideration Water for pharmaceutical processes Biofilms

Microbial Bioprocesses
Inoculum preparation A pharmaceutical process (microbial fermentation) Brewing and/or cheesemaking

Animal cell culture
Introduction to Animal Cell Bioprocessing, Recombinant Proteins & Biotherapeutics, Cell lines & Selection Systems, Genomics & Proteomics

Bioprocessing
Upstream Bioprocessing & Bioreactors Parts 1 and 2, Downstream Bioprocessing & Protein Purification Parts 1 and 2 Fill-finish & Formulation Operations

Regulation
Regulatory Affairs Parts 1 and 2

Analysis
Protein Assays Protein Characterization by Mass Spectrometry Bioassays Immunoassays & Case Studies

Assessment Breakdown
Continuous Assessment	0%	Examination Weight	100%

Type	Description	% of total	Assessment Date
Course Work Breakdown

Reassessment Requirement
Resit arrangements are explained by the following categories; 1 = A resit is available for all components of the module 2 = No resit is available for 100% continuous assessment module 3 = No resit is available for the continuous assessment component
Unavailable

Indicative Reading List

Michael Butler: 2007, Cell Culture and Upstream Processing, Taylor & Francis,
Leda Castilho (Editor), Angela Moraes (Editor), Elisabeth Augusto (Editor), Mike Butler (Editor): 2007, Animal Cell Technology: From Biopharmaceuticals to Gene Therapy, Taylor & Francis,
Rajni Hatti-Kaul (Editor), Bo Mattiasson (Editor): 2005, 3. Isolation and Purification of Proteins (Biotechnology and Bioprocessing), Taylor & Francis,

Other Resources

None

Programme or List of Programmes

AS	BSc in Analytical Science
BSSA	Study Abroad (DCU Business School)
BSSAO	Study Abroad (DCU Business School)
BT	BSc in Biotechnology
ECSA	Study Abroad (Engineering & Computing)
ECSAO	Study Abroad (Engineering & Computing)
HMSA	Study Abroad (Humanities & Soc Science)
HMSAO	Study Abroad (Humanities & Soc Science)
SHSA	Study Abroad (Science & Health)
SHSAO	Study Abroad (Science & Health)

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