Simple process capability analysis and quality validation of monoclonal antibody production in bench-top bioreactor
The production of monoclonal antibody (MAbs) for anti-cancer by fermentation of hybridoma cell in bench-top bioreactor was investigated. The main aim of this study was to increase the percentage of cell viability and to achieve high yield of IgM. Many ways can be applied to improve the process and...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Academic Journals
2011
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| Subjects: | |
| Online Access: | http://irep.iium.edu.my/13646/ http://irep.iium.edu.my/13646/ http://irep.iium.edu.my/13646/ http://irep.iium.edu.my/13646/1/Mel_et_al.pdf |
| Summary: | The production of monoclonal antibody (MAbs) for anti-cancer by fermentation of hybridoma cell in
bench-top bioreactor was investigated. The main aim of this study was to increase the percentage of
cell viability and to achieve high yield of IgM. Many ways can be applied to improve the process and
one of them is by choosing the correct six sigma’s design of experiment (DOE). In this study, Taguchi’s
experimental design was applied to achieve high percentage of cell viability in the fermentation
experiment. The process capability of this study was later analyzed by using the MiniTab Software (Ver.
14). Analysis showed that this study fulfilled a minimum target of process improvement as indicated by
the Cp and Cpk value of 0.90 and 0.86. This proved that the fermentation experiment has achieved cell
viability of more than 80% throughout the study. |
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