Module: Case Studies in Biotherapeutic Development(workshop module)

Latest Module Specifications

Current Academic Year 2025 - 2026

Module Title	Case Studies in Biotherapeutic Development(workshop module)
Module Code	BTE1030 (ITS: BE564)
Faculty	Biotechnology	School	Science & Health
NFQ level	9	Credit Rating	5

Description

Background : Recombinant DNA technology has made possible the preparation of large amounts of highly purified and characterized bioactive materials, whilst gene manipulation has enabled the engineering of biotherapeutic products with enhanced pharmacological properties. Compared to conventional small molecule drugs these are large complex products, but they have significant advantages in terms of specificity and efficacy. Such attractive features have triggered an explosion in precision treatment options for widespread diseases such as cancer and diabetes as well as creating new opportunities for the development of therapies for rare diseases and conditions previously untreatable. However, the complexity and sophistication of biotherapeutic production presents unique challenges to the development pipeline as small changes to the manufacturing process can significantly adversely impact product quality, safety, stability, and yield. Therefore, a prerequisite for introducing such biological substances into routine clinical use is to ensure consistency of quality, and for this purpose robust manufacturing processes are developed on the basis of process understanding and characterization, including appropriate in-process controls. Module Aims : Using examples from the pharmaceutical industry, and a field trip to the National Institute for Bioprocessing Research (NIBRT), students will explore and develop an understanding of the steps involved and technical challenges in the biotherapeutic drug development process. Topics studied include target identification, the choice of host expression systems, product purification strategies, process control measures, downstream product characterisation, biological activity assay, safety testing and product formulation.

Learning Outcomes

1. LO1: (understand) Critical awareness of emerging biotechnologies and new biotherapeutic drug classes.
2. LO2: (understand) Advanced knowledge on how biotherapeutic molecules are manufactured.
3. LO3: (apply) Critically contrast the advantages and disadvantages of the different technologies employed in the manufacture of biotherapeutics.
4. LO4: (analyse) Using examples from the pharmaceutical industry, critically explain the new biotherapeutic development process from initial target identification, including the use of artificial intelligence, to biological activity verification to match clinical endpoints.
5. LO5: (remember) Systematic understanding of the steps involved in bringing a new biotherapeutic to the market, from pre-clinical testing through human clinical trials.
6. LO6: (evaluate) Critical awareness of the meaning and importance of product quality control, with references to the particular challenges associated with biotherapeutics production and to the appropriate regulatory framework.
7. LO6: (apply) Specialised examples of in-process controls and product testing procedures used to ensure product quality standards are met.
8. LO8: (create) Apply advanced knowledge and systematic understanding to design processes for the manufacture and quality assurance of a new biotherapeutic.

*Type*	*Hours*	*Description*
Workload	Full time hours per semester
Workshop	12	In-person workshop
Fieldwork	8	Trip to a realistic GMP simulated, operational manufacturing environment at the National Institute for Bioprocessing Research and Training
Independent Study	100	Reference to reading materials. Work on project assignment.
Assessment Feedback	4	Presentation of project poster and oral description to peer group.
Assignment Completion	1	Oral exam
Workshop	12	In-person workshop
Fieldwork	8	Trip to a realistic GMP simulated, operational manufacturing environment at the National Institute for Bioprocessing Research and Training
Independent Study	100	Reference to reading materials. Work on project assignment.
Assessment Feedback	4	Presentation of project poster and oral description to peer group.
Assignment Completion	1	Oral exam
Total Workload: 250

Section Breakdown
CRN	20115	Part of Term	Semester 2
Coursework	0%	Examination Weight	0%
Grade Scale	40PASS	Pass Both Elements	Y
Resit Category	RC2	Best Mark	N
Module Co-ordinator	Gary Lawrence	Module Teacher	Janosch Heller

Type	Description	% of total	Assessment Date
Assessment Breakdown
Oral Examination	Oral assignment on a topic of relevance to the subject area.	25%	Week 30
Group presentation	Small group project with powerpoint presentation and oral description to peer group. Individuals will present individual subsections of the work performed and will be assessed based on their performance. Each group member will also be assessed on knowledge of content by individual questioning after completion of the presentation.	50%	Sem 2 End
Written Exam	Students are set challenge based questions to assess understanding of course content. Students must answer 4 questions from a panel of 8 - 10 options provided. Answers should be between 0.5 - 1 page long (typically 150 - 300 words).	25%	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

Workshop
Using examples from the pharmaceutical industry, and a field trip to the National Institute for Bioprocessing Research (NIBRT), students will explore and develop an understanding of the steps involved and technical challenges in the biotherapeutic drug development process. Topics studied include target identification (including the use of AI), the choice of host expression systems, product purification strategies, process control measures, downstream product characterisation, biological activity assay, safety testing and product formulation.

Fieldwork
Trip to a realistic GMP simulated, operational manufacturing environment at the National Institute for Bioprocessing Research and Training

Indicative Reading List

Books:

Richard A. Smith, Brian K. Kaspar and Clive N. Svendsen: 2020, Neurotherapeutics in the Era of Translational Medicine,

Articles:

0: Industrial Production of Therapeutic Proteins: Cell Lines, Cell Culture, and Purification, https://doi.org/10.1007%2F978-3-319-52287-6_29, 522251, 1
Development of mRNA manufacturing for vaccines and therapeutics: mRNA platform requirements and development of a scalable production process to support early phase clinical trials: https://doi.org/10.1016%2Fj.trsl.2021.11.009, 522252, 1,
https://doi.org/10.3390/bioengineering1040188:

Other Resources

None