This module explores the manufacture of biopharmaceuticals, with a focus on protein drugs. The module is split between upstream processes (week 1) and downstream processes (week 2) although the linkages between upstream and downstream are stressed in each week.
In week 1, students are introduced to the use of a variety of hosts for the production of biopharmaceuticals, spanning the major industrially-used systems (bacteria, yeast, mammalian cells). Lectures cover the growth of these cells at small and large scales, use of these systems to synthesise protein drugs, and analysis of process and product. The overall objective is to enable students to choose the correct host for a given protein product and design a process to use this host.
In week 2, downstream processing is covered, including the following: General downstream processing, Recombinant protein hosts, Cell disruption strategies, Aggregation, Fractional precipitation, Centrifugation and centrifuges, Conventional filtration, Membrane separations. Introduction to process chromatography, and alternatives to chromatography.
Principles and theories of chromatography: adsorption & adsorption models; resolution & zone broadening; three phase strategies & linking steps; process development; development of media; scale-up & optimisation.
Learning Outcomes
By the end of the module students should be able to:
Describe and compare the principles of microbial, insect and animal cell culture and their scale-up.
Assess the advantages and disadvantages of the wide range of analytical techniques used for monitoring bioprocesses and apply such knowledge to the design and operation of bioreactors for specific industrial bioprocesses.
Demonstrate comprehensive understanding of the practices employed in the recovery of industrially important molecules typically produced by fermentation;
Systematically design detailed downstream process design flow sheets for any bioproduct when supplied with relatively little information concerning, e.g. the intended use, amount required, the host, and some characteristics of the product;
Select the appropriate equipment, chromatographic materials and process chemicals for each of the various stages in a downstream process.
Assessment
41487-01 : Coursework : Coursework (50%)
41487-02 : Class Test : Class Test (50%)
Assessment Methods & Exceptions
Assessment:
50% coursework – max 2000-word report on upstream processes for the synthesis of biopharmaceutical products
