title: Safety of the production process of SURFACEN(®) to inactivate and remove virus.
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 of this product should guarantee safety from health hazards. The SURFACEN(®) production procedure is capable of effective viral clearance (inactivation/removal) by involving two stages of organic solvent extraction followed by acetone precipitation and heat treatment. In this study, we evaluated the clearance capacity of these four stages for a wide range of viruses by performing spiking experiments. Residual contamination was assessed using a Tissue Culture Infectious Dose assay (log10 TCID50). The validation study demonstrated that, for all viruses tested, the TCID50 titers were reduced by more than 2 log10 in each stage. Total log reduction values achieved were between ≥17.82 log10 and ≥27.93 log10, depending on the virus physical properties, titer, and the number of processing stages applied. Results indicated that the production procedure of SURFACEN(®) can inactivate or remove contaminant viruses from the raw material.
authors.affiliation: AIDS Research Laboratory, Autopista Nacional y Carretera de Jamaica, San José de las Lajas, CP 32700, Mayabeque, Cuba. yorsanchez@infomed.sld.cu
authors.forename: Yordank
authors.initials: Y
authors.lastname: Sánchez
authors.forename: Enrique
authors.initials: E
authors.lastname: Noa
authors.forename: Wilma
authors.initials: W
authors.lastname: Alfonso
authors.forename: Marta
authors.initials: M
authors.lastname: Dubed
authors.forename: Giselle
authors.initials: G
authors.lastname: Alvarez
authors.forename: Leonor
authors.initials: L
authors.lastname: Navea
authors.forename: Nivian
authors.initials: N
authors.lastname: Montes de Oca
authors.forename: Leonor
authors.initials: L
authors.lastname: Lobaina
authors.forename: Elaine
authors.initials: E
authors.lastname: Díaz
mesh_terms: D000818:Animals; D002417:Cattle; D004203:Disinfection / Q000379:methods*; D006801:Humans; D008168:Lung / Q000737:chemistry; D010743:Phospholipids / Q000737:chemistry / Q000494:pharmacology*; D037661:Pulmonary Surfactant-Associated Proteins / Q000737:chemistry / Q000494:pharmacology*; D013552:Swine; D038301:Virus Inactivation / Q000187:drug effects*; D014780:Viruses
chemical_list: D010743:Phospholipids; D037661:Pulmonary Surfactant-Associated Proteins; C569617:surfacen
keywords: SURFACEN(®); Viral safety