Module: Formulation & Delivery of Biopharmaceuticals

Latest Module Specifications

Current Academic Year 2025 - 2026

Module Title	Formulation & Delivery of Biopharmaceuticals
Module Code	BTE1023 (ITS: BE486)
Faculty	Biotechnology	School	Science & Health
NFQ level	8	Credit Rating	5

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	No Description
Directed learning	109	No Description
Total Workload: 125

Section Breakdown
CRN	20103	Part of Term	Semester 2
Coursework	0%	Examination Weight	0%
Grade Scale	40PASS	Pass Both Elements	Y
Resit Category	RC1	Best Mark	N
Module Co-ordinator	Caroline Devery Geoghegan	Module Teacher	Denis Collins, Denise Harold, Linda Holland, Paul Cahill, Paula Meleady

Type	Description	% of total	Assessment Date
Assessment Breakdown
Formal Examination	n/a	100%	End-of-Semester

Reassessment Requirement Type
Resit arrangements are explained by the following categories; RC1: A resit is available for both^* components of the module. RC2: No resit is available for a 100% coursework module. RC3: No resit is available for the coursework component where there is a coursework and summative examination element. ^* ‘Both’ is used in the context of the module having a coursework/summative examination split; where the module is 100% coursework, there will also be a resit of the assessment

Pre-requisite	None
Co-requisite	None
Compatibles	None
Incompatibles	None

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.

Indicative Reading List

Books:

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

Articles:
None

Other Resources

None