Module: Commercial Biotechnology & Biopharma

Module Specifications.

Current Academic Year 2024 - 2025

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Date posted: September 2024

Module Title	Commercial Biotechnology & Biopharma
Module Code	BE416 (ITS) / BTE1017 (Banner)
Faculty	Science & Health	School	Biotechnology
Module Co-ordinator	Paula Meleady
Module Teachers	Denise Harold, Linda Holland, Paul Cahill
NFQ level	8	Credit Rating	5
Pre-requisite	Not Available
Co-requisite	Not Available
Compatibles	Not Available
Incompatibles	Not Available

Coursework Only
Category 1 - a re-sit is available for all assessment components of the module.

Description

To introduce students to the key factors underpinning the commercialization 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. Communicate appropriately to the public concerning scientific advances and applications.
2. 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.
3. Explain the factors and issues involved in commercializing a biotech product, with special reference to new drug development, clinical trials and biosimilars.
4. Outline the benefits of Six Sigma methodology, Quality Assurance (QA), Good Manufacturing Practice (GMP) and Standard Operating Procedures (SOPs) to manufacturing processes.
5. Describe in broad terms the impact of –omics technologies on diagnostics and therapeutics, and the potential for “personalized” approaches to disease treatment.
6. Outline ethical and social questions, raised by advances in biotechnology, in their legal, regulatory and intellectual property contexts.

*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

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

BE416 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.

Assessment Breakdown
Continuous Assessment	100%	Examination Weight	0%

Type	Description	% of total	Assessment Date
Course Work Breakdown
Assignment	Biosafety/Bioethics Assignment	30%	n/a
Group assignment	Biotech Company Case Study plus Oral Q&A session on submission of assignment	40%	n/a
In Class Test	In class test	30%	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

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

Other Resources

None