AJUSTE DE PARÁMETROS PARA EL ESTUDIO DEL RETO VIRAL EN LA VALIDACIÓN DEL PROCESO DE PRODUCCIÓN DEL SURFACEN

Validation of viral clearence capacity in biological manufacturing process is necessary to offer a final product with an appropiated accurancy level and in this procedure should be ajusted the conditions that allow the precision of the study. The aim of this paper was to stablish the procedure of processing samples and to demostrate the feasibility of using viral models in validation of SURFACEN ® production process. The samples of the production steps were diluted 1:5 and 1:10 in buffer solution. Serial dilution were made and it was selected the dilution which citotoxicity was moderate. Five viral models were diluted 1:10 in pulmonary washes in order to determine the interference. It was taken an initial sample and a second one after one hour. None interference was consider when the difference between viral tittles was less than 2 log. Morphology of cells showed from light to high changes in 1:5 dilution, whereas in 1:10 dilution variation was minimun to moderate during the citotoxicity study. The last one dilution was selected to process the samples. The viral models tittles in presence of pulmonary washes decrease lower than 2 log, without significant differences. These results allowed to stablish the methodology for processing samples and showed the feasibility of viral models in the validation of viral clearence capacity of the SURFACEN ® production process.