An ultra-high yield intravenous immune globulin preparation

C - Chemistry – Metallurgy – 07 – K

Patent

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C07K 16/06 (2006.01) A61K 39/395 (2006.01) C07K 1/14 (2006.01) C07K 1/34 (2006.01)

Patent

CA 2621025

An efficacious large-scale alcohol-free plasma fractionation production process which produces a high-yielding, non-denatured, double viral- inactivated intravenous human immune gamma globulin (IgG) product. The process employs one or more salts from a group of salts comprising sodium citrate, sodium acetate, sodium gluconate, ammonium sulfate, sodium chloride, sodium sulfate and ammonium chloride in two initial fractionation steps, followed by diaflltration to remove those salts employed. A process which employs alcohol via the process of the disclosed inventive method is also disclosed.

L'invention concerne un procédé de production de masse efficace, par fractionnement de plasma exempt d'alcool, qui permet de produire une immunoglobuline (IgG) humaine intraveineuse double inactivée en termes de virus, non dénaturée et à haut rendement. Il est prévu selon ledit procédé d'utiliser un ou plusieurs sels d'un groupe de sels comprenant le citrate de sodium, l'acétate de sodium, le gluconate de sodium, le sulfate d'ammonium, le chlorure de sodium, le sulfate de sodium te le chlorure d'ammonium en deux étapes de fractionnement initiales, suivies par une diafiltration pour éliminer les sels utilisé. L'invention concerne également un procédé faisant appel à l'utilisation d'alcool par le biais du procédé selon l'invention.

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