Module: Commercial Biotechnology & Biopharma

Module Specifications

Academic Year 2025 - 2026

Module Title	Commercial Biotechnology & Biopharma
Module Code	BTE1017 (ITS: BE416)
Faculty	Science & Health	School	Biotechnology
NFQ level	8	Credit Rating	5

Description

To introduce students to the key factors underpinning the commercialisation and manufacture of biopharma and biotechnology products. To review the impact of emerging technologies on the industry. To review industry status and trends globally, in Europe and in Ireland. To discuss the social and ethical issues raised by some aspects of biotechnology. To review the impact of -omics technologies, and the potential for “personalized medicine”, on the biotechnology sector in particular, and on society in general. To encourage students’ awareness and development of their individual strengths, and to enable them to work productively in groups.

Learning Outcomes

1. Identify and describe the main features and requirements of different markets within the global biotechnology industry (incl. biopharma), and their diverse range of products and job opportunities.
2. Explain the factors and issues involved in commercializing a biotech product, with special reference to new drug development, clinical trials and biosimilars.
3. Outline the benefits of Six Sigma methodology, Quality Assurance (QA), Good Manufacturing Practice (GMP) and Standard Operating Procedures (SOPs) to manufacturing processes.
4. Describe in broad terms the impact of –omics technologies on diagnostics and therapeutics, and the potential for “personalized” approaches to disease treatment.
5. Outline ethical and social questions, raised by advances in biotechnology, in their legal, regulatory and intellectual property contexts.
6. Demonstrate knowledge of relevant ethical theories.
7. Analyse ethical issues by applying ethical theories.
8. Outline a course of action informed by ethical theories.
9. Reflect upon personal or collective action through an ethical lens.
10. Communicate appropriately to the public concerning scientific advances and applications.
11. Demonstrate awareness of the strengths and areas for development that one brings to a team.
12. Recognise and value the strengths that each individual brings to a team.
13. Fulfil one's task responsibilities within a team.
14. Demonstrate collaborative communication in a team environment.
15. Effectively engage with challenges that may emerge within a team.

*Type*	*Hours*	*Description*
Workload	Full time hours per semester
Lecture	24	No Description
Assignment Completion	25	No Description
Independent Study	76	No Description
Total Workload: 125

Section Breakdown
CRN	20096	Part of Term	Semester 2
Coursework	100%	Examination Weight	0%
Grade Scale	40PASS	Pass Both Elements	N
Resit Category	RC1	Best Mark	N
Module Co-ordinator	Paula Meleady	Module Teacher	Denis Collins, Denise Harold, Finbarr O'Sullivan, Linda Holland, Paul Cahill

Type	Description	% of total	Assessment Date
Assessment Breakdown
Group assignment	Biotech Company Case Study plus Oral Q&A session on submission of assignment	40%	n/a
Assignment	Bioethics/Biosafety Assignment	30%	n/a
In Class Test	In class test from material covered in weeks 1-6	15%	n/a
In Class Test	In class assessment on material from weeks 7-12	15%	n/a

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

BTE1017 Main Topics
FUNDAMENTALS; PUBLIC PERCEPTION Overview of the biotechnology industry & its main market sectors; public & media perceptions. BIOSAFETY SPECIAL-INTEREST SECTORS Application of biotech to disease diagnosis & treatment; the future of personalized medicine, an economic analysis; industrial enzymes & ‘bio-derived’ commodities; biotech applications in the agri/food sector; ethical considerations in the uses of biotechnologies. THE BIOTECHNOLOGY INDUSTRY Bioprocessing & industrial manufacture of biotech & biopharma products; the biotechnology industry globally, in Europe & in Ireland. RESEARCH AND INNOVATION Biotechnology research processes; university-industry relationships; intellectual property protection & licensing; translating research to product; new product development; clinical trials. QUALITY ASSURANCE/ CONTROL Compliance & quality issues in manufacturing, regulatory matters, GMP, ISO 9000, SOPs, lean six sigma manufacturing, clean technologies, special quality issues in biotechnology.

n/a

Indicative Reading List

Books:

Behme, S: 0, Manufacturing of pharmaceutical proteins: from technology to economy. 2nd edition, 9783527683093
Sherlock, R., Morrey, J.D. (Eds): 0, Ethical Issues in Biotechnology, 9780742513570
Rifkin, Jeremy: 0, The Biotech Century, 9780753808481
Bryant, J., Baggott la Velle, Searle, J. (Eds): 0, Bioethics for Scientists, 9780471495321

Articles:
None

Other Resources

None