Resumo

DUBED ECHEVARRIA, Marta et al. Validation of the capacity of the human albumin pasteurization process for virus inactivation. Rev Cubana Hematol Inmunol Hemoter [online]. 2011, vol.27, n.3, pp. 333-341. ISSN 0864-0289.

The validation of the capacity of viral clearance in the manufacturing processes of biopharmaceuticals is a regulatory requirement in Cuba. It is recommended to introduce the pasteurization in the manufacturing processes of serum albumin as a method of inactivating viruses. The objective of this study was to validate the capacity of viral inactivation in the phase of pasteurization of the 20 % and 25 % human albumin production process The viral models covering the possible pollutants of the raw materials were diluted at 1:10 in albumin in 2 concentrations and they were heat-treated at 60 °C for 10 h. Several samples at different time intervals were taken to design the inactivation kinetic curves. The reduction factor of pasteurization for each virus was estimated. The treatment of 20 % and 25 % albumin at 60 °C decreased significantly the initial viral load in the stage, with p< 0.002 and p< 0.021 respectively. The reduction factors exceeded 4 log of the titers of all viruses. The stage of pasteurization gave adequate level of safety to the 20 % and 25 % human albumin.

Palavras-chave : validation; pasteurization; reduction factors.

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