Registry

Module Specifications

Current Academic Year 2012 - 2013
Please note that this information is subject to change.

Module Title	Industrial Bioprocessing
Module Code	BE401
School	School of Biotechnology
Online Module Resources
Module Co-ordinator	Semester 1: Brid Quilty Semester 2: Brid Quilty Autumn: Brid Quilty
Module Teacher	Brid Quilty
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

Workload	Full-time hours per semester
*Type*	*Hours*	*Description*
Lecture	30	No Description
Tutorial	2	No Description
Independent learning time	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 industrySourcing microorganismsMaintenance and preservation of microbial cultures.

Working with microorganisms.
Classification of microorganisms based on safetySafe handling/Containment optionsGMOs and regulatory authorities.

Methods for detecting and identifying microorganisms.
CulturabilityMolecular techniquesChemical techniques.

Water quality.
Water quality control - microbial considerationWater for pharmaceutical processesBiofilms.

Microbial Bioprocesses.
Inoculum preparationA 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 2Fill-finish & Formulation Operations.

Regulation.
Regulatory Affairs Parts 1 and 2.

Analysis.
Protein AssaysProtein Characterization by Mass SpectrometryBioassaysImmunoassays & Case Studies.

Assessment Breakdown
Continuous Assessment	0%	Examination Weight	100%

Course Work Breakdown
Type	Description	% of total	Assessment Date

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
This module is category 1

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

Array

Programme or List of Programmes

BSc in Analytical Science

BSSA

Study Abroad (DCU Business School)

BSSAO

Study Abroad (DCU Business School)

BSc in Biotechnology

ECSA

Study Abroad (Engineering & Computing)