Registry

Module Specifications

Archived Version 2013 - 2014

Module Title	Bioprocess Scale Up & Technology Transfer
Module Code	BE581
School	School of Biotechnology
Online Module Resources
Module Co-ordinator	Dr Jenny Lawler	Office Number	X221
NFQ level	9	Credit Rating	5
Pre-requisite	None
Co-requisite	None
Compatibles	None
Incompatibles	None

Description

This module will provide an overview of the regulatory, technical and management issues associated with the scale-up and transfer of industrial bioprocesses. The focus will be on giving a clear understanding of the technical/regulatory requirements and approaches necessary to obtain regulatory approval for product scale-up and transfer. It will provide guidance on how to implement efficient/effective projects and will also address such areas as process validation and the typical costs associated with these projects.

Learning Outcomes

1. Address the important analytical, process, engineering and regulatory aspects for technology transfer.
2. Demonstrate an understanding of the analytical methodologies to be applied in support of product characterisation and strategies to be employed in support of Comparability evaluations.
3. Demonstrate an understanding of the engineering and process characterisation requirements for bioprocess scale-up.
4. Effectively plan a technology transfer process

*Type*	*Hours*	*Description*
Workload	Full-time hours per semester
Lecture	16	No Description
Independent Study	109	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

Overview of process development lifecycle

Product characterisation overview – Product quality and comparability considerations

Overview of Analytical Product Characterisation and methods applied

Stats principles & considerations for biopharmaceuticals

Principles of Quality by Design and Process Characterisation.

Facility and Process Validation for Biotech

Cleaning Validation considerations for Biotech.

Analytical Method Development and Validation.

Technology Transfer (Overview, Strategies, Planning - Process and Analytical considerations)

Regulatory Requirements for biotech (Clinical & Commercial Transfers)

Assessment Breakdown
Continuous Assessment	100%	Examination Weight	0%

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

Biotechnology, PhRMA, Washington, DC,: 2002, Pharmaceutical Research & Manufacturers of America, 2002 New Medicines in Development,
EFPIS, Brussels: 2000, The Pharmaceutical Industry in Figures, European Federation of Pharmaceutical Industries Associations,,
Washington, DC,: 2002, Pharmaceutical Research & Manufacturers of America, 2002 Industry Profile, PhRMA,,
Washington, DC, 2002: 0, Pharmaceutical Research & Manufacturers of America, 2002 New Medicines in Development – Biotechnology,PhRMA,,
Grabowski, H. and Vernon, J; Journal of Health Economics, Vol. 13, 1994: 0, Returns on R & D on New Drug Introductions in the 1980’s,
EFPIA, Brussels: 0, The Pharmaceutical Industry in Figures, European Federation of Pharmaceutical Industries Associations, 2002,
Price Waterhouse Coopers, 1998: 0, Pharma 2005 – An Industrial Revolution in R & D,,
D. Hardman, Biotech Advantage, DTI, Issue 6 July 2002: 0, The Route to Spin-out,

Other Resources

7321, Fitzpatrick, B., 0, An up-to-date reading list will be supplied throughout the module,

Programme or List of Programmes

GCBE	Graduate Cert in Bioprocess Engineering
GDBE	Graduate Dip in Bioprocess Engineering
MSBE	Master of Science in Bioprocess Engineer
SAMPB	STAND ALONE MODULE (BIOTECHNOLOGY)

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