Biopharmaceuticals and Upstream Processing

Overview

Summary of Lecture Content:
This module will focus on what biopharmaceuticals are, why they are needed and how they are produced. In further detail, the student will examine the different types of biopharmaceutical product including mABs and ADCs including what types of modifications are required to produce the latter, examples of each and what types of diseases they are employed to treat. The second part of the module will look at the upstream processing of a biopharmaceutical engineering process, cell banks and the need for different media for different cell lines.
The module is delivered over the following two lecture series:

Block 1: Biopharmaceuticals
This series contains the information and rationale for the need for biopharmaceutical products and the different types of biopharmaceutical products which are available. One of the key lectures which will be delivered will provide clarity around the difference between a standard drug and a biopharmaceutical, how a traditional drug is synthesised and why due to complexity a biopharmaceutical product cannot simply be put together in a lab in a similar way. The structures of some and also how they are biosynthesised within the host cell. Some organic chemistry will be discussed in detail with reference to Antibody-Drug Conjugates and what role they play in the treatment of disease.
• Series 1 Lectures
o Lecture 1: Traditional drugs and their limitations
o Lecture 2: What is a biopharmaceutical?
o Lecture 3: Context and case-studies in today’s world of medicine
o Lecture 4: Types of biopharmaceuticals
o Lecture 5: Monoclonal antibodies
o Lecture 6: Glycosylation and QbD
o Lecture 7: Modification of therapeutic proteins

Block 2: Upstream processing
This lecture series will focus on the practical side of biopharmaceutical production, from looking at cell growth, cell death, cell metabolites and also some kinetic modelling when applied to mass balance.
• Series 2 Lectures:
o Lecture 8: Cell death: Why and how to manage it
o Lecture 9: Cell proliferation
o Lecture 10: Metabolites of a cell when producing a biopharmaceutical
o Lecture 11: Conditions of upstream processing 
o Lecture 12: Mass balance
o Lecture 13: Scale-up from batch to plant
o Lecture 14: Controlling pathogens

Summary of Workshops:
• Workshop 1: Introduction to drugs and the need for biopharmaceuticals
• Workshop 2: mABs and Glycosylation mechanisms
• Workshop 3: Cell metabolites and significance
• Workshop 4: Scaling up considerations

Summary of Module Delivery:
The two lecture series described herein will be delivered in person on campus, this will allow students to approach the relevant academic should any queries arise. it will also provide a more seamless transition into discussion between academic and student. The workshops will be designed in a way that will allow either a Teams format, on-campus format or blended. The blended approach will be beneficial as the workshops on Teams will be recorded and therefore will allow reference during private study time.

Learning Objectives

At the end of the module the students are expected to:
• Understand that traditional drugs which are available on the market in terms of their ability to treat illnesses
• Critically analyse the need for biopharmaceuticals when it comes to illnesses that traditional drugs cant treat- compare the two types of product in detail
• Recall and describe in detail the different types of biopharmaceutical product which is available on the market
• Analyse the components of a medium and comment on efficiency and whether or not it can be classified as being ‘nutrient-rich’ and sufficient for cell proliferation
• Create a plan for the scale-up of an upstream process

Skills

Skills Associated with Module:
• Logical thinking
• Critical and interdisciplinary thinking.
• Ability to review literature, to produce written documents and reports.
• Analytical skills

Assessment

Course Requirements:
Coursework submission: 40%
Total Coursework elements must be passed at: 50%