Module Specifications..
Current Academic Year 2024 - 2025
Please note that this information is subject to change.
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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. | |||||||||||||||||||||||||||||||||||||||||
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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 | |||||||||||||||||||||||||||||||||||||||||
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 |
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Indicative Content and Learning Activities
Overview of process development lifecycleProduct characterisation overview – Product quality and comparability considerationsOverview of Analytical Product Characterisation and methods appliedStats principles & considerations for biopharmaceuticalsPrinciples of Quality by Design and Process CharacterisationFacility and Process Validation for BiotechCleaning Validation considerations for BiotechAnalytical Method Development and ValidationTechnology Transfer (Overview, Strategies, Planning - Process and Analytical considerations)Regulatory Requirements for biotech (Clinical & Commercial Transfers) | |||||||||||||||||||||||||||||||||||||||||
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Indicative Reading List
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Other Resources 61380, Fitzpatrick, B., 0, An up-to-date reading list will be supplied throughout the module, | |||||||||||||||||||||||||||||||||||||||||
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Programme or List of Programmes
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