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PHAR40210

Academic Year 2024/2025

Biotherapeutic Pipeline II (PHAR40210)

Subject:
Pharmacology
College:
Science
School:
Biomolecular & Biomed Science
Level:
4 (Masters)
Credits:
5
Module Coordinator:
Assoc Professor David O'Connell
Trimester:
Spring
Mode of Delivery:
On Campus
Internship Module:
No
How will I be graded?
Letter grades

Curricular information is subject to change.

Over the last three decades biotherapeutics have become an integral and valued part of modern medicine. These decades have seen an explosion in the development of blockbuster drugs developed to treat a widening range of complex diseases and have witnessed the rapid maturation of the science of development of engineered proteins. Biotherapeutics have significant advantages over small molecule therapies since they have been shown to be even more effective due to their ability to target specific molecules within the human body. However, unlike most conventional small molecules like aspirin and antibiotics, the development, manufacturing and storage of biotherapeutics is more complex and require sophisticated production and control processes. In contrast with small molecule therapeutics, biotherapeutics depend upon the host cells of living organisms to effectively produce the active pharmaceutical ingredient.

Aims: The main focus of this module is to study in detail the technical issues surrounding the biotherapeutic new product development process (NPD), focusing particularly on the engineering of host expression systems, protein purification challenges, downstream characterisation of purified products, safety and efficacy testing and formulation strategies for biotherapeutics. Students will learn in detail the production challenges of the pipeline in this module.

Literature: A comprehensive reading list from peer reviewed journals will be supplied by the module coordinator

About this Module

Learning Outcomes:

Learning Outcomes:
This module is designed to help students to understand and appreciate the challenges and opportunities that the biotherapeutics industry faces in developing powerful medicines for treatment of our most difficult diseases. Students will learn:
• How are biotherapeutic molecules made
• Strategies and technologies in the development of new biotherapeutic drugs
• Technical challenges in maximising expression of biotherapeutics
• Challenges in purification of biotherapeutics
• Focus areas in the biotherapeutics industry where companies are developing new drug classes e.g., ADCs and Bispecifics
• A detailed understanding of the holistic process of developing a biotherapeutic and the multidisciplinary nature of this activity
• Recognise and utilise the skills involved in managing a group project

Student Effort Hours:
Student Effort Type Hours
Lectures

24
Tutorial

6
Seminar (or Webinar)

3
Autonomous Student Learning

83
Total

116

Approaches to Teaching and Learning:
12 2 hour lectures with in class discussions and Q&A will form the basis of the module with enjoyable group based components including team based postr and quiz assignments. Tutorials on essay writing and exam preparation will be in addition to lectures.

Requirements, Exclusions and Recommendations

Not applicable to this module.


Module Requisites and Incompatibles
Not applicable to this module.
 

Assessment Strategy  
Description Timing Component Scale Must Pass Component % of Final Grade In Module Component Repeat Offered
Quizzes/Short Exercises: This short answer quiz of 40 minutes duration with 24 questions will ensure that you are keeping up with the course material Week 6 Standard conversion grade scale 40% No

20

 No
Group Work Assignment: Poster presentation on a biotherapeutic pipeline company exemplar. This group presentation will be judged by your classmates and this peer to grading and feedback component will be graded Week 12 Standard conversion grade scale 40% No

20

 No
Exam (In-person): End of trimester essay examination Week 14 Standard conversion grade scale 40% No

60

 No

Carry forward of passed components
Yes
 

Resit In Terminal Exam
Summer Yes - 2 Hour
Please see Student Jargon Buster for more information about remediation types and timing. 

Feedback Strategy/Strategies

• Feedback individually to students, post-assessment

How will my Feedback be Delivered?

Invitation to meet to discuss post-assessment

Name Role
Assoc Professor Siobhán McClean Lecturer / Co-Lecturer
Professor Keith Murphy Lecturer / Co-Lecturer
Dr Tanja Narancic Lecturer / Co-Lecturer
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