Course Details in 2024/25 Session

Module Title	LM Pharmaceuticals and Therapeutic Biologicals from Bench to Market
School	School of Bioscience
Department	School of Biosciences
Module Code	03 27374
Module Lead	Dr Scott White
Level	Masters Level
Credits	20
Semester	Semester 2
Pre-requisites
Co-requisites	LM Funding Science - (03 22937)
Restrictions	None
Exclusions
Description	This module covers different types of therapeutic biologicals (also known as biopharmaceuticals) used for diagnosis, prevention and treatment of serious and chronic diseases. These molecules are generally large, complex modified proteins derived from living material. The module will focus on the production and use of therapeutic monoclonal antibodies, but cytokines, hormones, enzymes and vaccines will also be covered.The production of these molecules and their mode of action will be described. Through participation in the group project, students will study the typical “time-line” of drug product development. This will include: drug discovery, developability, pre-clinical studies, formulation, clinical trials, primary and secondary manufacturing, marketing and post marketing activities, patents and intellectual property, the regulatory and quality environment of the pharmaceutical industry, and quality by design approaches to pharmaceutical manufacturing.
Learning Outcomes	By the end of the module students should be able to: Understand the theoretical basis for the production, mode of action and pre-clinical development of a range of pharmaceuticals and therapeutic biologicals, through co-authorsip of a joint group report; Handle and interpret data that relate to the production, mode of action and development of pharmaceuticals and therapeutic biologicals as assessed by a data-handing test; Describe and demonstrate an understanding of the key stages in the development of a pharmaceutical drug product by researching and producing an outline proposal for expansion to a joint group report; Demonstrate an understanding of the regulatory and quality environment of the pharmaceutical industry through co-authorship of a joint report; Demonstrate an understanding of and evaluate current and emerging strategies for improving pharmaceutical manufacturing processes; Work successfully in a group to produce a report; Complete a reflective practice document on skill enhancement as an individual team member and as a group.
Assessment	27374-03 : Continuous Assessment : Coursework (100%)
Assessment Methods & Exceptions	Group exercise on producing a report describing a particular therapeutic biological in terms of its mode of action and production (70%) comprising: a) Individual activities - CV (formative 0%); 2-page proposal (10%); Step 1 Review (2.5%; Reflective practice (10%) b) Group Activities – Step 2 Peer Review (2.5%); Group report (45%) c) word limit = 2,500 words(does not include tables, references and figure legends). Written in-course data interpretation test (30%) Reassessment: A written assessment combining the learning outcomes of the data interpretation and group report to test student knowledge of mode of action and methods of production of a therapeutic biological with mark capped at 50% pass mark.
Other	None
Reading List