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Virus safety of human immunoglobulins: Efficient inactivation of hepatitis C and other human pathogenic viruses by the manufacturing procedure
Author(s) -
Nowak Thomas,
Gregersen JensPeter,
Klockmann Ulrich,
Cummins Larry Bill,
Hilfenhaus Joachim
Publication year - 1992
Publication title -
journal of medical virology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.782
H-Index - 121
eISSN - 1096-9071
pISSN - 0146-6615
DOI - 10.1002/jmv.1890360311
Subject(s) - virology , virus , hepatitis c virus , antibody , flaviviridae , japanese encephalitis , flavivirus , hepatitis e virus , pestivirus , biology , microbiology and biotechnology , encephalitis , immunology , biochemistry , gene , genotype
Human immunoglobulins are plasma derivatives with a low risk of transmitting viral infections. To the present, no proven case of human immunoglobulins transmitting human immunodeficiency viruses has been reported. However, there have been a few reports on the transmission of hepatitis C virus by these plasma proteins. To improve further the safety of both 5s iv human immunoglobulins and 7s im immunoglobulins, we introduced a 10‐hour heat treatment of the aqueous solutions a t 60°C (i.e., pasteurization) into the manufacturing procedure. This treatment was not added to the manufacturing procedure of 7s iv immunoglobulin that already contained the S‐sulfonation as a virus inactivating method. We now report on experimental data that show that the whole manufacturing procedures of the above immunoglobulins inactivate efficiently hepatitis C virus and that the specific virus inactivation methods alone, namely, pasteurization or S‐sulfonation, also inactivate completely viruses of the flavivirus family, to which the hepatitis C virus belongs. The inactivation of the Flaviviridae bovine viral diarrhea virus, tick‐borne encephalitis virus, and yellow fever virus by pasteurization or S‐sulfonation was at least 10 5 . The clearance of HCV achieved by the entire manufacturing process of each of these immunoglobulins was also at least 10 5 . The experiments therefore show that pasteurization or S‐sulfonation provides a high margin of safety to human immunoglobulins regarding the transmission of hepatitis C virus.