General Details

Full Title
Transcript Title
N/A %
Subject Area
BIO - Bio Tech/Eng/Chem
LIFE - Life Sciences
08 - Level 8
05 - 05 Credits
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Mary Butler
Programme Membership
SG_SBIOP_E08 201900 Level 8 Certificate in Science in Biopharmaceutical Science SG_SBIOP_K08 201900 Bachelor of Science (Honours) in Biopharmaceutical Science. SG_SBIOM_H08 201800 Bachelor of Science (Honours) in Science in Biomedical and BioIndustrial Sciences SG_SBIOM_H08 202000 Bachelor of Science (Honours) in Biomedical and Bioindustrial Sciences SG_SAPMS_H08 202000 Bachelor of Science (Honours) in Applied Medical Sciences SG_SBIOP_K08 202200 Bachelor of Science (Honours) in Biopharmaceutical Science (Add-on) SG_SBIOP_E08 202200 Certificate in Biopharmaceutical Science

This module aims to provide the learner with a deep understanding of the key theoretical concepts and principles of protein purification (downstream processing) as part of biotherapeutic protein manufacturing. The module will address all key steps in downstream processing from product recovery using different filtration techniques and/or centrifugation, to protein product capture, purification and polishing using various chromatographic techniques, and viral clearance. Consideration will be given to the selection of chromatographic methods, their operation, process scale-up and evaluation of column performance. Sources of viral loads from cell culture and other avenues will be discussed including techniques for their elimination.

Learning Outcomes

On completion of this module the learner will/should be able to;


Outline the main elements of an effective and efficient downstream process design for protein capture and purification.


Explain downstream processing technologies such as microfiltration, ultrafiltration, diafiltration, and centrifugation.


Discuss the general theory and principles of chromatography technology for protein purification applications and the application of this theory to evaluating column performance.


Compare and contrast the different types and modes of chromatography used in downstream processing.


Describe the various viral exclusion and elimination technologies for downstream processing as well as relevant quality control methods.


Perform research on a relevant topic and communicate in writing and orally an informed and evidence based analysis and evaluation of current thinking, with appropriate conclusions.

Teaching and Learning Strategies

as above

Module Assessment Strategies

Continuous Assessment of Course Work - 30% of marks.

End of term online exam - 30% of marks.

Mini research project - 40% of marks.

The miniproject is a MANDATORY form of assessment for any modules on this programme with a miniproject component.

Repeat Assessments

as per Q manual

Indicative Syllabus

Indicative Syllabus

  1. Introduction to protein purification.
  2. The design and operation of an effective protein capture, purification and polishing system.
  3. The theory and principles of chromatography for purification.
  4. The different types of chromatography systems for protein purification including process scale chromatography.
  5. Other purification technologies - microfiltration, ultrafiltration, diafiltration, centrifugation.
  6. Viral exclusion technologies for protein purification; viral contamination problems and viral filtration steps.
  7. Quality control techniques for protein purification.

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
100 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Open Book Exam Online Coursework Assessment UNKNOWN 15 % Week 4 1,2
2 Open Book Exam Online Coursework Assessment UNKNOWN 15 % Week 9 3,4
3 Individual Project Mini Research Coursework Assessment UNKNOWN 40 % Week 15 6

End of Semester / Year Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Other Exam Online Final Exam Closed Book Exam 30 % Week 14 1,2,3,4,5

Part Time Mode Workload

Type Location Description Hours Frequency Avg Workload
Lecture Not Specified Online 2 Weekly 2.00
Directed Learning Not Specified Course Notes 4 Weekly 4.00
Independent Learning UNKNOWN Mini Research Activities 4 Weekly 4.00
Total Part Time Average Weekly Learner Contact Time 2.00 Hours

Required & Recommended Book List

Required Reading
2007-08-13 Pharmaceutical Biotechnology John Wiley & Sons
ISBN 9780470012444 ISBN-13 0470012447

Offers a comprehensive introduction to the principles and concepts of pharmaceutical biotechnology.

Required Reading
2003 Bioseparations Science and Engineering
ISBN 0195123409 ISBN-13 9780195123401

Other unique features include basic information about bioproducts and engineering analysis and a chapter with bioseparations laboratory exercises. Bioseparations Science and Engineering is ideal for students and professionals alike."--BOOK JACKET.

Required Reading
2003-02-05 Isolation and Purification of Proteins CRC Press
ISBN 0824707265 ISBN-13 9780824707262

This publication details the isolation of proteins from biological materials, techniques for solid-liquid separation, concentration, crystallization, chromatography, scale-up, process monitoring, product formulation, and regulatory and commercial considerations in protein production. The authors discuss the release of protein from a biological host, selectivity in affinity chromatography, precipitation of proteins (both non-specific and specific), extraction for rapid protein isolation, adsorption as an initial step for the capture of proteins, scale-up and commercial production of recombinant proteins, and process monitoring in downstream processing.

Module Resources

Non ISBN Literary Resources

A variety of current topical peer-review papers will be provided via the virtual learning environment (VLE) module page for each lecture to illustrate current thinking on key issues.

Url Resources

Free to download e-books

Strategies for Protein Purification - GE Healthcare LifeSciences

Protein Purification Handbook - Amersham Biosciences

Protein Concentration & Diafiltration by TFF - Millipore Handbook

Journal Resources

as above

URL Resources

Free to download e-books

Strategies for Protein Purification - GE Healthcare LifeSciences

Protein Purification Handbook - Amersham Biosciences

Protein Concentration & Diafiltration by TFF - Millipore Handbook

Other Resources


Additional Information