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NES8809 : Biopharmaceuticals as Therapeutics

  • Offered for Year: 2023/24
  • Module Leader(s): Dr Agnieszka Bronowska
  • Lecturer: Professor Jarka Glassey, Dr James Knight
  • Owning School: Natural and Environmental Sciences
  • Teaching Location: Newcastle City Campus

Your programme is made up of credits, the total differs on programme to programme.

Semester 2 Credit Value: 10
ECTS Credits: 5.0
European Credit Transfer System


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

Teaching Methods

Teaching Activities
Category Activity Number Length Student Hours Comment
Guided Independent StudyAssessment preparation and completion158:0058:00Prep for assessment
Guided Independent StudyAssessment preparation and completion101:0010:00Skills practice
Guided Independent StudyAssessment preparation and completion12:002:00assessment
Scheduled Learning And Teaching ActivitiesLecture201:0020:00Lectures/Seminars including Case Studies
Scheduled Learning And Teaching ActivitiesDrop-in/surgery52:0010:00Drop-in Problem Solving Sessions
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 Methods

The format of resits will be determined by the Board of Examiners

Other Assessment
Description Semester When Set Percentage Comment
Written exercise2A100Topics – Produce a literature review from a selection of topics – (max 5 pages)
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 **

Reading Lists