Module: Bioprocess Scale Up & Technology Transfer

Latest Module Specifications

Current Academic Year 2025 - 2026

Module Title	Bioprocess Scale Up & Technology Transfer
Module Code	BTE1032 (ITS: BE581)
Faculty	Biotechnology	School	Science & Health
NFQ level	9	Credit Rating	5

Description

This module will provide an overview of the regulatory, technical and management considerations associated with the characterization, scale-up and transfer of industrial bioprocesses. The focus will be on providing a clear understanding of the technical/regulatory requirements and approaches necessary to obtain regulatory approval for process and product characterization, scale-up and transfer. It will provide guidance on how to efficiently implement biotech processes and will also address such areas as cleaning and process validation and the typical phases associated with the lifecycle development and tech transfers of 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 detailed product comparability evaluations.
3. Demonstrate an understanding of the engineering and process characterisation requirements for bioprocess scale-up.
4. Effectively plan and execute 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

Section Breakdown
CRN	20116	Part of Term	Semester 2
Coursework	0%	Examination Weight	0%
Grade Scale	40PASS	Pass Both Elements	Y
Resit Category	RC1	Best Mark	N
Module Co-ordinator	David Collins	Module Teacher	Brian Freeland, Denise Harold, Jonathan Cawley, Paul Cahill

Type	Description	% of total	Assessment Date
Assessment Breakdown
Assignment	Homework Assignment	100%	Week 1

Reassessment Requirement Type
Resit arrangements are explained by the following categories; RC1: A resit is available for both^* components of the module. RC2: No resit is available for a 100% coursework module. RC3: No resit is available for the coursework component where there is a coursework and summative examination element. ^* ‘Both’ is used in the context of the module having a coursework/summative examination split; where the module is 100% coursework, there will also be a resit of the assessment

Pre-requisite	None
Co-requisite	None
Compatibles	None
Incompatibles	None

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)

Indicative Reading List

Books:

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,

Articles:
None

Other Resources

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