Manufacturing method for intravenous immune globulin and...

A - Human Necessities – 61 – K

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A61K 38/12 (2006.01) A61K 35/14 (2006.01) A61L 2/00 (2006.01) C07K 16/00 (2006.01) C07K 16/06 (2006.01) C12N 7/04 (2006.01) C12N 7/06 (2006.01)

Patent

CA 2375560

A continuous process for producing an intravenously-administrable gamma globulin solution substantially free of contaminating viruses by heat treating a gamma globulin solution for viral inactivation, fractionating to obtain a purified gamma globulin solution without precipitation of the desired gamma globulin and then treating the purified gamma globulin with a solvent- detergent for further viral inactivation. Partially purified gamma globulin solids is not recovered as an intermediate product during the disclosed process.

L'invention concerne un procédé continu pour la production d'une solution de gammaglobuline administrable par voie intraveineuse, sensiblement exempte de virus contaminants, par le traitement thermique d'une solution de gammaglobuline, en vue d'un fractionnement à inactivation virale, de manière qu'une solution de gammaglobuline soit produite sans précipitation de la gammaglobuline voulue, et par le traitement de la gammaglobuline traitée à l'aide d'un solvant détergent, en vue d'une inactivation virale supplémentaire. Les solides de gammaglobuline partiellement purifiée ne sont pas récupérés sous forme de produit intermédiaire, au cours du procédé de l'invention.

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