Safety of the production process of SURFACEN® to inactivate and remove virus
作者： Yordank Sánchez , Enrique Noa , Wilma Alfonso , Marta Dubed , Giselle Álvarez
DOI: 10.1016/J.BIOLOGICALS.2013.04.003
关键词:
摘要: Abstract SURFACEN ® is a biological product produced from pig lungs. Since these animals can be potential sources of microbial pathogens such as viruses, the manufacturing process this should guarantee safety health hazards. The production procedure capable effective viral clearance (inactivation/removal) by involving two stages organic solvent extraction followed acetone precipitation and heat treatment. In study, we evaluated capacity four for wide range viruses performing spiking experiments. Residual contamination was assessed using Tissue Culture Infectious Dose assay (log 10 TCID 50 ). validation study demonstrated that, all tested, titers were reduced more than 2 log in each stage. Total reduction values achieved between ≥17.82 ≥27.93 , depending on virus physical properties, titer, number processing applied. Results indicated that inactivate or remove contaminant raw material.
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