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Module Specifications

Archived Version 2021 - 2022

Module Title Bioprocess Scale Up & Technology Transfer
Module Code BE581
School School of Biotechnology

Online Module Resources

Module Co-ordinatorDr Jenny LawlerOffice NumberX221
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 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



Workload Full-time hours per semester
Type Hours Description
Lecture16No Description
Independent Study109No 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 Assessment100% Examination Weight0%
Course Work Breakdown
TypeDescription% of totalAssessment 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
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

36436, Fitzpatrick, B., 0, An up-to-date reading list will be supplied throughout the module,
Programme or List of Programmes
AMPDPhD
AMPMMSc
AMPTPhD-track
BTPDPhD
BTPMMSc
BTPTPhD-track
CHPDPhD
CHPMMaster of Science
CHPTPhD-track
GCBEGraduate Cert in Bioprocess Engineering
GDBEGraduate Dip in Bioprocess Engineering
HHPDPhD
MSBEMSc in Bioprocess Engineering
NSPDPhD
NSPMMSc
NSPTPhD-track
PHPDPhD
PHPMMSc
PHPTPhD-track
PYPDPhD
PYPMMSc
PYPTPhD-track
SMPSCSingle Module Prof. Science and Health
SSPDPhD
SSPMMSc
SSPTPhD-track
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