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Module Specifications..

Current Academic Year 2023 - 2024

Please note that this information is subject to change.

Module Title Commercial Biotechnology & Biopharma
Module Code BE416
School School of Biotechnology
Module Co-ordinatorSemester 1: Paula Meleady
Semester 2: Paula Meleady
Autumn: Paula Meleady
Module TeachersPaul Cahill
Paula Meleady
Denise Harold
Linda Holland
NFQ level 8 Credit Rating 5
Pre-requisite None
Co-requisite None
Compatibles None
Incompatibles None
Coursework Only
Category 1 - a re-sit is available for all assessment components of the module.

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.

Workload Full-time hours per semester
Type Hours Description
Lecture24No Description
Assignment Completion25No Description
Independent Study76No 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 Assessment100% Examination Weight0%
Course Work Breakdown
TypeDescription% of totalAssessment Date
EssayBiosafety Essay30%n/a
EssayShort Essay20%n/a
Group assignmentBiotech Company Case Study30%n/a
Loop QuizOnline MCQ20%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

  • Behme, S: 0, Manufacturing of pharmaceutical proteins: from technology to economy. 2nd edition, 9783527683093
  • Behme, S.: 0, Manufacturing of pharmaceutical proteins: from technology to economy. 2nd edition, 9783527337668
  • 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

Programme or List of Programmes
BTBSc in Biotechnology
GCBBSc in Genetics & Cell Biology

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