Abstract

GARCIA, José et al. The risk analysis used to manufacture recombinant proteins in E. coli. Vaccimonitor [online]. 2012, vol.21, n.2, pp. 35-42. ISSN 1025-028X.

In this paper a risk analysis management is applied using the Failure Mode Effects Analysis to the fermentation processes that use E. coli as a host, to produce recombinant proteins with therapeutic, vaccinate or diagnostic aims. The analysis of the type and probability of occurrence of failures in the fermentation process, the evaluation of the impact in the quality of the product and the probability of detection of these failures are carried out. The severity, occurrence probability and detection probability are evaluated and the risk priority number is calculated. Techniques used in Quality assurance as brainstorming and Ishikawa diagram were used. The potential causes that have higher influence in the failures of a fermentation process of recombinant E. coli are: inadequate handling during inoculation, presence of phages and unqualified personnel. Actions to minimize the risks are proposed.

Keywords : Risk analysis; failure mode effect analysis; fermentation; recombinant protein.

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