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	BE486 (ITS) / BTE1023 (Banner)
Faculty	Science & Health	School	Biotechnology
Module Co-ordinator	Paul Cahill
Module Teachers	Denise Harold, Linda Holland, Paula Meleady
NFQ level	8	Credit Rating	5
Pre-requisite	Not Available
Co-requisite	Not Available
Compatibles	Not Available
Incompatibles	Not Available

None

Description

The aim of this module is to provide 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 formulation and delivery of therapeutic peptides, proteins, nucleic acid-based drugs and vaccines will be described.

Learning Outcomes

1. List the major challenges in delivery of Biopharmaceuticals and explain why advanced delivery systems are needed
2. Describe how protein and peptide injectables may be chemically modified for improved delivery
3. Critically discuss novel non-injectable formulation approaches of peptide and protein drugs
4. Cite clinical trials using chemical and viral vectors for delivery of nucleic acids.
5. Evaluate commercial feasibility of lipid nanoparticles and polymer-based delivery systems for achieving real clinical applications.
6. Explain the role of freeze-drying technology in drug delivery systems

*Type*	*Hours*	*Description*
Workload	Full-time hours per semester
Lecture	16	Asynchronous and synchronous classes and tutorials
Directed learning	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

Lecture
Novel formulation and delivery approaches for peptide and protein injectables

Lecture
Novel non-injectable formulation approaches of peptides and proteins

Lecture
Chemical vectors and Viral technology for delivery of nucleic acids

Lecture
Polymer-Based delivery systems for oral and pulmonary delivery of peptides/proteins/nucleic acids. Role of Freeze drying technology in oral delivery systems.

Assessment Breakdown
Continuous Assessment	0%	Examination Weight	100%

Type	Description	% of total	Assessment Date
Course Work Breakdown

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, 4, New York: Informa Healthcare, 978-1-4614-64
edited by Michael E. Aulton and Kevin M.G. Taylor.: 2013, Aulton's pharmaceutics: the design and manufacture of medicines, 4, Philadelphia; Churchill Livingstone/Elsevier, 0702042900,
Lene Jorgensen (Editor), Hanne Morck Nielson (Co-Editor): 2009, Delivery Technologies for Biopharmaceuticals: Peptides, Proteins, Nucleic Acids and Vaccines, 978-0-470-723

Other Resources

None