Abstract

CADIZ, Armando et al. Viral Inactivation by pH and Temperature in Intaglobin preparations. Vaccimonitor [online]. 2001, vol.10, n.2, pp.19-24. ISSN 1025-028X.

Swine encephalomyocarditis (SE) was used as a model virus to study viral inactivation in the production process of a human immunoglobulin preparation for intravenous use. Two variables were selected for this: ph and temperature. Four experimental groups were prepared: acid pH (4,3) and 5 °C temperature, acid pH (4,3) and 28 °C temperature, basic pH (7,0) and 5 °C temperature and basic pH (7,0) and 28 °C temperature. In each case, to determine the rate of viral inactivation, samples were taken at different times. The best results with respect to decreasing infectivity were obtained for the samples treated with 4,3 pH and 28 °C temperature, with a total inactivation of the virus after 8 hours. In the samples treated under the other conditions, complete viral inactivation was only observed after 5 weeks. We checked that the chemical and organoleptic characteristics of the product remained unchanged during the 8 weeks the experiment lasted. We concluded that acid pH and high temperatures, as well as the incubation time are important variables in the viral inactivation kinetics.

Keywords : Intravenous immunoglobulin; viral inactivations; pH; temperature.

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