African Journal of
Biotechnology

  • Abbreviation: Afr. J. Biotechnol.
  • Language: English
  • ISSN: 1684-5315
  • DOI: 10.5897/AJB
  • Start Year: 2002
  • Published Articles: 12486

Full Length Research Paper

Simple process capability analysis and quality validation of monoclonal antibody production in bench-top bioreactor

Maizirwan Mel*, Mohd Azmir Arifin, Mohd Hider Kamarudin, Mohamed Ismail Abdul Karim and Faridah Yusof
Bioprocess and Biomolecular Engineering Research Unit (BPMERU), Kulliyyah of Engineering, International Islamic University Malaysia, Gombak, P.O. Box 10, 50728 Kuala Lumpur, Malaysia
Email: [email protected]

  •  Accepted: 07 November 2011
  •  Published: 16 December 2011

Abstract

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.

 

Key words: Monoclonal antibody, hybridoma, process capability, Taguchi experimental design