Module Catalogue 2024/25

Pre Requisite Comment

N/A

Co Requisite Comment

N/A

Aims

The purpose of this course is to provide students comprehensive understanding of the process of biological drug development. The course will make students familiar with major classes of biopharmaceuticals, and allow them to critically evaluate the current science underpinning a range of technical areas of biological drug development including design, discovery, manufacturing, formulation, preclinical and clinical testing, safety and efficacy. It will also provide an understanding of the legal regulatory framework and its implementation in biological drug development.

Outline Of Syllabus

This module will provide students with comprehensive understanding of the following topics:

• Biopharmaceuticals – the major classes
• Antibodies
• Antibody-drug conjugates
• RNA therapeutics
• Peptides
• Vaccines
• Case Study 1
• Biopharmaceutical drug discovery
• Manufacturing and its challenges
• Preclinical testing
• Clinical development
• Case Study 2
• Commercialisation of biopharmaceutical products
• Regulatory framework for biopharmaceuticals
• Case Study 3

Intended Knowledge Outcomes

At the end of the module, students will:

• Know the main classes of biopharmaceuticals and their major application areas;
• Understand strengths and limitations of biopharmaceutical therapeutics;
• Understand key bioconjugation reactions;
• Understand of the theoretical framework, strengths and limitations of different scale modelling techniques
suitable to develop antibody-drug conjugates and antibody-based diagnostics;
• Understand the biopharmaceutical development pipeline;
• Understand the commercialisation of biopharmaceuticals and its major challenges;
• Know key regulatory requirements for biopharmaceutical therapeutics;

Intended Skill Outcomes

Subject specific or professional skills, able to:

• Use information and data from different disciplines (biochemistry, immunology, chemistry, chemical biology,
bioinformatics, molecular modelling) and integrate them;
• Being able to evaluate experimental techniques used in pharmaceutical development;
• Being able to critically evaluate the peer-reviewed research papers and data included;
• Biomedical research-focused computer literacy;
• Learn new computer environment and software;
• Use several modelling and visualisation packages (such as UCSF Chimera, Autodock Vina) to model
biopharmaceuticals;
• Use online resources and databases (such as RCSB PDB, UniProt, PubMed, FTMap, Aggrescan3D, CyPreds, Rosetta)
to model biopharmaceuticals;

Cognitive or intellectual skills, able to:
• Interpret obtained published information, integrate it with calculated data, and extrapolate them to
predictions (e.g. sites of bioconjugation);
• Develop models and hypotheses based on experimental observations;
• Work as a team with other students to solve the research problem;

Key skills, able to:
• Plan and organise coursework effectively;
• Take accurate notes;
• Think critically

Teaching Rationale And Relationship

The purpose of this course is to provide students comprehensive understanding of the process of biological drug development. To do this, a variety of methods including lectures, workshops and seminars, will be used for delivery of the material and to ensure that students actively engage with the subject matter.

Assessment Rationale And Relationship

The summative assessment will assess the level of knowledge and understanding of all aspects of the module. The assessment will present students with questions from a selection of topics learnt throughout the module content.

** Students studying from abroad may request to take their exam before the semester 1 exam period, in which case the format of the paper may differ from that shown in the MOF. These students should contact the school to discuss this **

General Notes

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