BIO09004 2019 PROTEIN PURIFICATION PROCESSING
This module examines various downstream processing aspects of a typical biopharmaceutical production process. It includes the various design factors that need to be considered for the design of an effective and efficient protein capture and purification process.
On completion of this module the learner will/should be able to;
Design an effective and efficient downstream process for a protein capture and purification application.
Outline and evaluate the various approaches to primary capture of the target material focusing primarily on affinity chromatography.
Describe the theory and practice of chromatography for purification applications including the various chromatographic types available and their relative advantages and disadvantages.
Interpret and explain other downstream processing technologies such as microfiltration, ultrafiltration, diafiltration, centrifugation, electrophoresis and various viral exclusion techniques.
Outline and evaluate the main quality control and analytical techniques required for downstream processing.
Teaching and Learning Strategies
Module Assessment Strategies
as per Q manual
The range of topics covered will include some of the following: intracellular vs. extracellular protein in cell culture processing; the principles and operation of centrifugation; microfiltration, ultrafiltration, tangential flow filtration, diafiltration; chromatographic techniques including gel filtration, ion‑exchange (AEX and CEX), hydrophobic interaction, affinity‑based techniques for both primary capture and protein purification ; HETP and asymmetry in chromatography; viral exclusion technologies; quality control and analytical techniques for downstream processing.
Coursework & Assessment Breakdown
|Title||Type||Form||Percent||Week||Learning Outcomes Assessed|
|1||MCQ/SAQ Exam||Continuous Assessment||Open Book Exam||10 %||Week 4||1,2|
|2||MCQ/SAQ Exam||Continuous Assessment||Open Book Exam||10 %||Week 7||3,4|
|3||LAQ||Continuous Assessment||Closed Book Exam||30 %||Week 10||1,2,3,4,5|
|4||Project Report and Presentation||Project||Assignment||50 %||Week 14||1,2,3,4,5|
Part Time Mode Workload
|Independent Learning||UNKNOWN||Self Study||7||Weekly||7.00|
Required & Recommended Book List
2006-02-08 Biopharmaceuticals John Wiley & Sons
ISBN 9780470868393 ISBN-13 0470868392
The latest edition of this highly acclaimed textbook, provides a comprehensive and up-to-date overview of the science and medical applications of biopharmaceutical products. Biopharmaceuticals refers to pharmaceutical substances derived from biological sources, and increasingly, it is synonymous with 'newer' pharmaceutical substances derived from genetic engineering or hybridoma technology. This superbly written review of the important areas of investigation in the field, covers drug production, plus the biochemical and molecular mechanisms of action together with the biotechnology of major biopharmaceutical types on the market or currently under development. There is also additional material reflecting both the technical advances in the area and detailed information on key topics such as the influence of genomics on drug discovery.
1988 Bioseparations Wiley-Interscience
Offers a concise introduction to the separation and purification of biochemicals. Bridges two scientific cultures, providing an introduction to bioseparations for scientists with no background in engineering and for engineers with little grounding in biology. The authors supplement the ideas by simple worked examples, making the techniques of bioseparations easy to learn. Discusses removal of insolubles, product isolation, purification and polishing.
Walsh, Gary, Biopharmaceuticals., Wiley, 2003
Belter, P.A. and Cussler, E.L and Wei‑Shou Hu., Bioseparations: Downstream Processing for Biotechnology, Wiley‑Interscience, 1988
Amersham Pharmacia (GE Healthcare)., Series of Chromatography Manuals for industrial applications.,
Amersham‑Pharmacia. ( www.amersham.com ), 2000