BIO08034 2019 Cell Culture Processing
This module aims to provide the student with a broad understanding of both the theory and practical aspects of cell culture processing as it pertains to the biosynthesis of modern biopharmaceutical products. It will deal with the processing flow from cell vial thaw and subsequent scale-up through to protein synthesis and product capture.
Learning Outcomes
On completion of this module the learner will/should be able to;
Describe the basics of cell biology and the process kinetics relating to cell growth and productivity for a bioreactor process.
Explain the different types and formulations of media available and their overall importance in optimising the cell culture process.
Utilising a selected cell line perform the scale-up process for bioreactor inoculation and describe the main steps involved and their function.
Perform cell counting techniques utilising appropriate technology to verify cell density performance during bioreactor operation.
Describe the various bioreactor designs available and their key features including relative advantages and disadvantages of different operating modes.
Operate a bioreactor and control the various key parameters to demonstrate the impact on protein synthesis and biomass performance.
Perform a cell / protein harvesting step utilising either filtration or chromatography technologies.
Report written laboratory work to an industry standard, including data interpretation and statistical analysis.
Teaching and Learning Strategies
This module will be delivered fulltime. This will include lectures, laboratory practicals, and a site visit to the national Institute of Bioprocessing Research and Training. 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 and 35% Final exam'. There will be 2 MCQs given during the semester, one mid semester and the second at the end of the semester. The student must reach an assigned gate (30%) in the final exam and achieve 40% overall to pass the subject’
Laboratory skills and report-writing ability are assessed as part of the practical work performed during the module. Regular written laboratory report assignments encourage engagement with the module, monitor progress and provide feedback.
Repeat Assessments
Repeat Continuous Assessment or Written Report Submission, and/or Final Exam.
Module Dependencies
Indicative Syllabus
1. Overview of Cell Biology relating to Cell Culture Processing and Bioreactor Operations.
2. Kinetics of Cell Growth, Yield and Productivities, cell counting techniques, cell density and cell viability measurements.
3. Cell Culture Media Design and Formulation.
4. Energy and Mass Transfer Systems for Bioprocessing.
5. Bioreactor Design and Engineering.
6. Bioreactor Operation and Control of critical parameters for protein synthesis.
7. Cell harvesting technology including filtration and/or chromatography technologies.
8. Filter functionality, filter integrity testing, sterile connect technology, instrument calibration, sterilisation operations.
Coursework & Assessment Breakdown
Coursework Assessment
Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
---|---|---|---|---|---|---|
1 | Mid term exam. | Coursework Assessment | Multiple Choice/Short Answer Test | 15 % | Week 5 | 2,5 |
2 | Written Report Laboratory Practical | Coursework Assessment | Written Report/Essay | 50 % | Any | 3,4,6,7,8 |
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 | 1,2,5 |
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 Learning | 1 | Weekly | 1.00 |
Practical / Laboratory | Science Laboratory | Laboratory Practical | 3 | Weekly | 3.00 |
Independent Learning | UNKNOWN | Self Study | 4 | Weekly | 4.00 |
Off-Site Activity | Offsite Facility | NIBRT trip | 0 | Once Per Semester | 0.00 |
Module Resources
‘Pharmaceutical Biotechnology - Concepts and Applications' by Gary Walsh.
Wiley Publications. 2007. ISBN - 978-0-470-01244-4.
‘Basic Biotechnology' by Colin Ratledge and Bjorn Kristiansen.
Cambridge Press. 2001. ISBN - 0-521-779170.
'Bioprocess Engineering - Basic Concepts' by Shuler,M.L. and Kargi F.
Prentice-Hall. 2002. ISBN - 0-13-081908-5.
Biopharma International
www.fda.gov
www.sartorius.com
www.ge.com
www.ich.org
Students undertake one day of training in Single Use Systems and Cleaning In Place at the National Institute for Bioprocessing Research and Training.
None