Method for preparing dual virally inactivated immune...

A - Human Necessities – 61 – K

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A61K 35/16 (2006.01) C07K 16/06 (2006.01)

Patent

CA 2371356

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.

L'invention concerne un procédé de production d'une solution de gamma-globuline administrable par voie intraveineuse, sensiblement exempte de virus contaminant, par fractionnement d'une solution de gamma-globuline impure et par traitement de ladite gamma-globuline purifiée, dans n'importe quel ordre, à l'aide d'un mélange détergent-solvant pour l'inactivation virale et d'un traitement thermique pour l'inactivation virale. Les impuretés dénaturées, le solvant résiduel, le solvant et l'agrégat générés par le traitement thermique sont ensuite enlevés de la gamma-globuline.

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