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Module Specifications.

Current Academic Year 2024 - 2025

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Date posted: September 2024

Module Title Bioprocess Scale Up & Technology Transfer
Module Code BE581 (ITS) / BTE1032 (Banner)
Faculty Science & Health School Biotechnology
Module Co-ordinatorDavid Collins
Module TeachersBrian Freeland, Denise Harold, Jonathan Cawley, Paul Cahill
NFQ level 9 Credit Rating 5
Pre-requisite Not Available
Co-requisite Not Available
Compatibles Not Available
Incompatibles Not Available
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
AssignmentHomework Assignment100%
Reassessment Requirement Type
Resit arrangements are explained by the following categories:
Resit category 1: A resit is available for both* components of the module.
Resit category 2: No resit is available for a 100% continuous assessment module.
Resit category 3: No resit is available for the continuous assessment component where there is a continuous assessment and examination element.
* ‘Both’ is used in the context of the module having a Continuous Assessment/Examination split; where the module is 100% continuous assessment, there will also be a resit of the assessment
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,
Other Resources

61380, Fitzpatrick, B., 0, An up-to-date reading list will be supplied throughout the module,

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