Registry

Module Specifications

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

Module Title	Bioprocess Scale Up & Technology Transfer
Module Code	BE581
School	School of Biotechnology
Online Module Resources
Module Co-ordinator	Semester 1: Dermot Walls Semester 2: Dermot Walls Autumn: Dermot Walls
NFQ level	8	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

Workload	Full-time hours per semester
*Type*	*Hours*	*Description*
Lecture	16	No Description
Independent learning	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.
Technology Transfer (Overview, Strategies, Planning).

Regulatory Requirements (Clinical & Commercial Transfers).
Overview of Analytical Product Characterisation and methods applied.

Equipment Selection & Utility Requirements.
Process Technology & Validation.

Analytical Method Transfer/Qualification.
PAT (Process Analytical Technology).

Process Scale-up (Equipment/Validation/Regulatory Requirements).
Process Modeling (Scale down Systems) and Process Characterisation studies.

Integration of a New Process intoRoutine Operations on the Site.
Cost of Technology Transfer & Ways to Ensure Project Success.

Disposable Bioreactor Technology.
Practical Examples of Technology Transfer.

Assessment Breakdown
Continuous Assessment	100%	Examination Weight	0%

Course Work Breakdown
Type	Description	% of total	Assessment Date
Assignment	Homework Assignment	100%	n/a

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

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,