General Details

Full Title
Transcript Title
N/A %
Subject Area
BIO - Bio Tech/Eng/Chem
LIFE - Life Sciences
09 - NFQ Level 9
05 - 05 Credits
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Mary Butler
Programme Membership
SG_SBIOP_M09 201900 Master of Science in Biopharmaceutical Science SG_SBIOP_E09 201900 Postgraduate Certificate in BioPharmaceutical Science SG_SBIOP_M09 202300 Master of Science in Biopharmaceutical Science SG_SBIPR_M09 202300 Master of Science in Biopharmaceutical 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.  

Learning Outcomes

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

100% CA

Module Assessment Strategies

100% CA

Repeat Assessments

as per Q manual

Indicative Syllabus

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

Coursework & Continuous Assessment
100 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 MCQ/SAQ Exam Coursework Assessment Open Book Exam 10 % Week 4 1,2
2 MCQ/SAQ Exam Coursework Assessment Open Book Exam 10 % Week 7 3,4
3 LAQ Coursework 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

Type Location Description Hours Frequency Avg Workload
Lecture Not Specified Lecture 2 Weekly 2.00
Independent Learning UNKNOWN Self Study 7 Weekly 7.00
Total Part Time Average Weekly Learner Contact Time 2.00 Hours

Required & Recommended Book List

Required Reading
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.

Required Reading
1988 Bioseparations Wiley-Interscience
ISBN UOM:39015012755750

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.

Module Resources

Non ISBN Literary Resources

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. ( ), 2000  

Journal Resources

as above

URL Resources

as above

Other Resources