An improved process for pegylation of proteins

Details An improved process for pegylation of proteins An improved process for pegylation of proteins

C - Chemistry, Metallurgy

07

K

C07K 14/535 (2006.01) A61K 47/48 (2006.01)

Patent

CA 2741209

The present invention relates to a process for improving pegylation reaction yield of r-metHuG-CSF comprising conjugating r-metHuG-CSF to a PEG aldehyde at a free amine moiety at the N terminal end on the G-CSF in presence of a reducing agent in a pegylation buffer solution comprising a polyol having the formula C n H2n+2O n where n is from 3 to 6, or a carbohydrate, or a derivative thereof wherein the concentration of said polyol or carbohydrate or derivative thereof is in the range of 0.1% to 10% w/w.

La présente invention concerne un procédé permettant d'améliorer le rendement de la réaction de pegylation de r-metHuG-CSF. Ce procédé consiste à conjuguer le r-metHuG-CSF à un aldéhyde de polyéthylène-glycol au niveau de la terminaison N d'un groupe amine libre en présence d'un agent réducteur dans une solution tampon pour pegylation. En l'occurrence, cette solution tampon pour pegylation comprendra, soit un polyol représenté par la formule CnH2n+2On dans laquelle "n" vaut de 3 à 6, soit un glucide, soit encore l'un de leurs dérivés, la concentration dudit polyol, glucide ou dérivé se situant dans une plage allant de 0,1% à 10% en poids.

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