Inactivación viral en el Intacglobín por el pH y la temperatura.
Viral Inactivation by pH and Temperature in Intaglobin preparations.
Armando Cádiz1, María Esther Castellano2, Dalia Rodríguez3, Rosa Iris Reina2, Janhna Hernández1, Alexandro Rodríguez4, Aniel Moya1.
1 Instituto Finlay, Centro de Investigación-Producción de Vacunas y Sueros. Ciudad de La Habana, Cuba. ]]>
E-mail:acadiz@finlay.edu.cu
2 Planta de Hemoderivados. Ciudad de La Habana, Cuba.
3 Instituto Nacional de Medicina Veterinaria. Ciudad de La Habana, Cuba.
4 Dpto. Inmunología ICBP Victoria de Girón. Ciudad de La Habana, Cuba
RESUMEN
Se utilizó la Encefalomiocarditis (EMC) porcina como virus modelo en el estudio de inactivación viral en el proceso de producción de un preparado de inmunoglobulina humana para uso intravenoso, para lo que se escogieron dos variables a tener en cuenta: el pH y la temperatura; preparándose cuatro grupos experimentales: pH ácido (4,3) y temperatura 5 °C, pH ácido (4,3) y temperatura 28 °C, pH básico (7,0) y temperatura 5 °C y por último pH básico (7,0) y temperatura 28 °C. Para cada caso se tomaron muestras a diferentes tiempos para conocer el grado de inactivación viral. Los mejores resultados en cuanto a la disminución de la infectividad, se obtuvieron para las muestras tratadas con pH 4,3 y temperatura 28 °C, mostrándose la total inactivación del virus, a partir de las 8 h. En las muestras tratadas bajo las otras condiciones, solo se observó la completa inactivación viral a partir de las cinco semanas. Verificamos que las características organolépticas y químicas del producto se mantuvieran inalterables durante el transcurso de las ocho semanas que duró el experimento.Llegamos a conclusiones acerca de que el pH ácido y las altas temperaturas, así como el tiempo de incubación, son variables importantes en la cinética de inactivación viral. ]]>
Palabras claves: Inmunoglobulina intravenosa, inactivación viral, pH y temperatura.
ABSTRACT
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 and temperature.
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