The validation of the biological production processes and their importance in the prevention of the HIV transmission
E. Noa1, M. Dubed1, L.M. Navea1, G. Álvarez1, Y.R. Sánchez1, M.A. Tuñón2, R. Barrios2, A.M. Hernández3, J.R. Pérez3, A.T. Ramírez4, A. Fragas1, L.I. Lobaina1
1AIDS Research Laboratory, La Habana, Cuba, 2Center of Genetic Engineering and Biotechnology, La Habana, Cuba, 3Hystoterapy Placentary Centers, La Habana, Cuba, 4Blood Products Processing Plant, La Habana, Cuba
Introduction: HIV can be a contaminant of the raw materials used in the production of biological of human origin and it has been demonstrated that viral security of the end product doesn´t only depend of the direct evaluation of viral markers in the starting material, but also of the demonstration that the process is able to remove or inactivate it. The aim of this paper was to demonstrate clearance capacity of HIV in the production processes of cubans biological.
Methods: The production processes of four cubans biological products derivative from human blood and placenta were carried to a laboratory scale and the stages considered with capacity for virus inactivate or remove was challenged with HIV-1 high doses. The determination of the viral replication was carried out by the microtitulation method using the Ag p24 quantification using DAVIH-Agp24 kits. The reduction factor (RF) of the viral title it was determined by stages and for the complete production processes.
Results: The stages of the challenged production process showed appropriated values of inactivation and removal of the HIV-1, fundamentally in those that lipids solvent and heat treatment used. All processes were considered safe due to the high reached securities of viral clearing [HEBERTRANS® (9.31 log); MELAGENINA® Plus (11.71 log); EP-100 (10.66 log) and human albumin (6.2 log)].:
Conclusions: The studied production processes have a design that allows the clearing of the HIV-1, what confers them in turn an appropriate security to the end product.
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