BIO08033 2019 PROTEIN PURIFICATION

General Details

Full Title
PROTEIN PURIFICATION
Transcript Title
PROTEIN PURIFICATION
Code
BIO08033
Attendance
N/A %
Subject Area
BIO - Bio Tech/Eng/Chem
Department
LIFE - Life Sciences
Level
08 - NFQ Level 8
Credit
10 - 10 Credits
Duration
Semester
Fee
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Author(s)
Macdara Bodeker
Programme Membership
SG_SMEDI_H08 201900 Bachelor of Science (Honours) in Science in Medical Biotechnology SG_SMEDI_K08 201900 Level 8 Honours Degree Add-on in Science in Medical Biotechnology
Description

This course aims to provide the student with a broad understanding of the main theory and practical aspects of protein purification (downstream processing) from product capture at the end of the cell culture process through the various stages of protein separation and purification including viral elimination.

Learning Outcomes

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

1.

Outline the main elements of an effective and efficient downstream process design for protein capture and purification application from DPC (direct product capture) to BDS (bulk drug substance). 

2.

Describe the general theory and main principles of chromatography technology for protein purification applications.

3.

Perform a protein capture step utilising ion exchange chromatography involving a suitable matrix resin.

4.

Outline and differentiate between the different types of chromatography systems in use for protein purification purposes.  

5.

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

6.
Operate the various forms of filtration technology available for purification purposes - normal flow filtration (microfiltration, ultrafiltration), tangential flow filtration, diafiltration etc. 
7.

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

8.

Report laboratory work to an industry standard, including effective data interpretation and statistical analysis.

Teaching and Learning Strategies

This module will be delivered full time. This will include lectures and laboratory practicals augmented by independent learning and directed learning. This approach is expected to address student learning needs. Moodle will be used as a repository of educational resources and as a means of assessment (e.g. quizzes, uploading assignments and journals). 

Module Assessment Strategies

This module is 65% Continuous Assessment 35% Final exam. There will be 2 MCQ tests given during the semester one mid, and one end of semester. Laboratory skills and report-writing ability are assessed as part of the practical work performed during the module. Regular summative assignments are used to encourage engagement with the module, monitor progress and provide feedback. The student must reach an assigned gate (30%) in the final exam and achieve 40% overall to pass the subject.

Repeat Assessments

Repeat Continuous Assessment or Written Report Submission, and/or Final Exam.

Module Dependencies

Prerequisites
None
Co-requisites
None
Incompatibles
None

Indicative Syllabus

1.       Introduction to Protein Purification (Downstream Processing).

2.       The Design and Operation of an effective Protein Capture System to include  the various technologies available - centrifugation, filtration, chromatography etc.  

3.       The Theory and Principles of Chromatography for Purification. 

4.       The Different Types of Chromatography Systems for Purification including ion-exchange (anion and cation), gel-filtration etc. 

5.       Other Purification Technologies - Microfiltration, Ultrafiltration, Diafiltration, Centrifugation, Electrophoresis. 

6.       Sterility testing and final product quality control and release. 

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
65 %
End of Semester / Year Formal Exam
35 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Written Report Laboratory Practical Continuous Assessment Written Report 50 % Any 3,5,7
2 Multiple Choice Mid-Term Exam Continuous Assessment Multiple Choice 7 % Week 5 1,2
3 Multiple Choice End-Term Exam Continuous Assessment Multiple Choice 8 % Week 12 1,2,4,5,7

End of Semester / Year Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 End of term exam. Final Exam Closed Book Exam 35 % Week 14 1,2,4,6,8
             
             

Full Time Mode Workload


Type Location Description Hours Frequency Avg Workload
Lecture Tiered Classroom Lecture 2 Weekly 2.00
Problem Based Learning Flat Classroom Problem based learingin 1 Weekly 1.00
Laboratory Practical Science Laboratory Biopharma Lab 3 Weekly 3.00
Independent Learning UNKNOWN Self Study 7 Weekly 7.00
Total Full Time Average Weekly Learner Contact Time 6.00 Hours

Module Resources

Non ISBN Literary Resources

‘Pharmaceutical Biotechnology - Concepts and Applications' by Gary Walsh.

Wiley Publications.  2007.  ISBN - 978-0-470-01244-4.

 

'Bioseparations Science and Engineering' by R.G. Harrison, P.Todd, S.R. Rudge, D.P. Petrides.   Oxford University Press. 2003.  ISBN - 0-19-512340-9.

'Isolation and Purification of Proteins' by R. Hatti-Kaul, B.Mattiasson.

Marcel-Dekker.  2003.  ISBN- 0-8247-0726-5.

Journal Resources

Biopharma International

 

URL Resources

https://www.chromacademy.com/

www.fda.gov

www.ich.org

Other Resources

None

Additional Information

None