Validation of the capacity of the human albumin pasteurization process for virus inactivation

Revista Cubana de Hematología, Inmunología y Hemoterapia

Lobaina Leyva, Leonor²  Noa Romero, Enrique²  Ramírez Más, Ana Teresa¹  Álvarez Seguí, Giselle²  Navea Leyva, Leonor²  Dubed Echevarría, Marta²  Sánchez Martínez, Yordank² 

[1] Empresa Productora de Sueros y Hemoderivados Alberto Pessant, La Habana, Cuba;Laboratorio de Investigaciones del SIDA, La Habana, Cuba

关键词: validation;    pasteurization;    reduction factors;   

DOI  :  

学科分类：生理学与病理学

来源: SciELO

【 摘 要 】

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.

【 授权许可】

CC BY-NC