Module: Formulation & Delivery of Biopharmaceuticals

Module Specifications.

Current Academic Year 2024 - 2025

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Date posted: September 2024

Module Title	Formulation & Delivery of Biopharmaceuticals
Module Code	BE586 (ITS) / BTE1037 (Banner)
Faculty	Science & Health	School	Biotechnology
Module Co-ordinator	Damien King
Module Teachers	Brian Freeland, David Collins, Denise Harold, Linda Holland, Paul Cahill, Paula Meleady
NFQ level	9	Credit Rating	5
Pre-requisite	Not Available
Co-requisite	Not Available
Compatibles	Not Available
Incompatibles	Not Available

None
This module is category 1

Description

The aim of this module is to provide bioprocess engineering students with a critical overview of the challenges in administering biopharmaceuticals and strategies for overcoming the main delivery barriers. State of the art concepts for successful delivery of therapeutic peptides, proteins, nucleic acid-based drugs and vaccines will be described.

Learning Outcomes

1. Describe novel formulation approaches for peptide and protein injectables (e.g. PEGylation, glycoengineering, acylation, amino acid substitution, protein fusion)
2. Discuss various depot delivery systems for peptide and protein injectables (eg micro-and nanoparticulate systems, in situ depot-forming systems, implant systems)
3. Identify challenges and strategies associated with intranasal, pulmonary, buccal, oral and transdermal delivery of peptides/protein drugs
4. Demonstrate an understanding of how chemical vectors and viral technology can overcome anatomical and cellular barriers for delivery of nucleic acids
5. Critically evaluate lipid nanoparticles and polymer-based systems for delivery of peptides, proteins, nucleic acids
6. Explain the role of freeze-drying technology in drug delivery systems

*Type*	*Hours*	*Description*
Workload	Full-time hours per semester
Assessment Feedback	16	Blended asynchronous and synchronous classes
Independent Study	109	Directed learning
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

Formulation and Delivery
Novel formulation and delivery approaches for peptide and protein injectables

Novel non-injectable formulations
Novel non-injectable formulation of peptides and proteins for oral and pulmonary delivery

Delivery of nucleic acids
Chemical vectors and Viral technology for delivery of nucleic acids

Polymer-Based delivery systems; role of freeze-drying technology
Polymer-Based delivery systems for oral and pulmonary delivery of peptides/proteins/nucleic acids. Role of freeze drying technology in oral drug delivery systems.

Assessment Breakdown
Continuous Assessment	100%	Examination Weight	0%

Type	Description	% of total	Assessment Date
Course Work Breakdown
Report(s)	A series of open-book reports prepared in response to tasks/questions assigned each week	100%	n/a

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

Sindelar, Robert D., editor; Meibohm, Bernd, editor; Crommelin, D. J. A. (Daan J. A) editor: 2013, Pharmaceutical Biotechnology: fundamentals and applications, 4th Edition, Informa, ISBN 978-1-46
Aulton: 2013, Aulton's pharmaceutics: the design and manufacture of medicines, 4th Edition, Churchill Livingstone, ISBN: 0702042
Lene Jorgensen (Editor), Hanne Morck Nielson (Co-Editor): 2009, Delivery Technologies for Biopharmaceuticals: Peptides, Proteins, Nucleic Acids and Vaccines, Wiley, 978-0-470-723

Other Resources

None