Method for preparing dual virally inactivated immune globulin for intravenous administration

The present invention relates to an integral, multi-step commercial process for the production of intravenously administrable immune globulin containing IgG ( -globulin) as the main ingredient. A process for producing an intravenously-administrable gamma globulin solution substantially free of conta...

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Main Authors Mamidi, Raja R, Bagdasarian, Andranik, Canaveral, Gorgonio, Takechi, Kazuo
Format Patent
LanguageEnglish
Published 07.01.2003
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Abstract The present invention relates to an integral, multi-step commercial process for the production of intravenously administrable immune globulin containing IgG ( -globulin) as the main ingredient. A process for producing an intravenously-administrable gamma globulin solution substantially free of contaminating viruses by fractionating an impure gamma globulin solution and then treating the purified gamma globulin, in any order, with a solvent-detergent for viral inactivation and a heat treating for viral inactivation. Thereafter, denatured impurities, residual solvent and aggregate generated by the heat treatment are removed from the gamma globulin.
AbstractList The present invention relates to an integral, multi-step commercial process for the production of intravenously administrable immune globulin containing IgG ( -globulin) as the main ingredient. A process for producing an intravenously-administrable gamma globulin solution substantially free of contaminating viruses by fractionating an impure gamma globulin solution and then treating the purified gamma globulin, in any order, with a solvent-detergent for viral inactivation and a heat treating for viral inactivation. Thereafter, denatured impurities, residual solvent and aggregate generated by the heat treatment are removed from the gamma globulin.
Author Canaveral, Gorgonio
Takechi, Kazuo
Bagdasarian, Andranik
Mamidi, Raja R
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Title Method for preparing dual virally inactivated immune globulin for intravenous administration
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