Module: Formulation & Delivery of Biopharmaceuticals

Module Specifications..

Current Academic Year 2023 - 2024

Please note that this information is subject to change.

Module Title	Formulation & Delivery of Biopharmaceuticals
Module Code	BE586
School	School of Biotechnology
Module Co-ordinator	Semester 1: Denise Harold Semester 2: Denise Harold Autumn: Denise Harold
Module Teachers	Paula Meleady Brian Freeland Denise Harold David Collins Linda Holland
NFQ level	9	Credit Rating	5
Pre-requisite	None
Co-requisite	None
Compatibles	None
Incompatibles	None

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; 1 = A resit is available for all components of the module 2 = No resit is available for 100% continuous assessment module 3 = No resit is available for the continuous assessment component
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

Programme or List of Programmes

GCBE	Graduate Cert in Bioprocess Engineering
GDBE	Graduate Dip in Bioprocess Engineering
MSBE	MSc in Bioprocess Engineering
SMPSC	Single Module Prof. Science and Health

Date of Last Revision

10-MAR-11

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