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KMID : 0545120010110040619
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Journal of Microbiology and Biotechnology
2001 Volume.11 No. 4 p.619 ~ p.627
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Improvement of Virus Safety of a Human Intravenous Immunoglobulin by Low pH Incubation
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Kim, In Seop
Choi, Yong Woon/Lee, Sung Rae/Cho, Hang Bok/Eo, Ho Gueon/Woo, Han Sang/Chang, Chong Eun
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Abstract
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In order to increase the virus safety of a human intravenous immunoglobulin (IVIg) that was manufactured by a successive process of cold ethanol fractionation, polyethylene glycol precipitation, and pasteurization (60℃ heat treatment for 10h), a low pH incubation process (pH 3.9 at 25℃ for 14 days) was employed as the final step. The efficacy and mechanism of the fraction Ⅲ cold ethanol fractionation, pasteurization, and low pH treatment steps in the removal and/or inactivation of blood-borne viruses were closely examined. A variety of experimental model viruses for human pathogenic viruses, including the Bovine herpes virus (BHV), Bovine viral diarrhoea virus (BVDV), Murine encephalomyocarditis virus (EMCV), and Porcine parvovirus (PPV), were selected for this study. The mechanism of reduction for the enveloped viruses (BHV and BVDV) during fraction Ⅲ fractionation was both inactivation and partitioning, however, it was partitioning in the case of the nonenveloped viruses (EMCV and PPV). The log reduction factors achieved during fraction Ⅲ fractionation were ≥6.7 for BHV, ≥4.7 for BVDV, 4.5 for EMCV, and 4.4 for PPV Pasteurization was found to be a robust and effective step in inactivating all the viruses tested. The log reduction factors achieved during the pasteurization process were ≥7.5 for BHV, ≥4.8 for BVDV, 3.0 for EMCV, and 3.3 for PPV A low pH incubation was very effective in inactivating the enveloped viruses as well as EMCV The log reduction factors achieved during low pH incubation were >7.4 for BHV, ≥3.9 for BVDV, 5.2 for EMCV, and 2.0 for PPV These results indicate that the low pH treatment successfully improved the viral safety of the final products.
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