Pegylated g-csf polypeptides and methods of producing same

Details Pegylated g-csf polypeptides and methods of producing same Pegylated g-csf polypeptides and methods of producing same

A - Human Necessities

61

K

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

Patent

CA 2607844

A method for increasing the stability and uniformity of a PEGylated G-CSF polypeptide having at least one PEG moiety attached to the epsilon amino group of a lysine residue or the N-terminal amino group and at least one PEG moiety attached to a hydroxyl group, comprising subjecting the polypeptide to an elevated pH of above 8.0 for a period of time suitable to remove PEG moieties attached to a hydroxyl group, and reducing the pH to about 8.0 or lower; as well as PEGylated G-CSF polypeptides and compositions produced according to the method and methods for increasing neutrophil levels in a patient using the PEGylated G-CSF polypeptides and compositions.

L'invention concerne un procédé destiné à augmenter la stabilité et l'uniformité d'un polypeptide G-CSF PEGylé présentant au moins une fraction PEG reliée au groupe amino epsilon d'un reste de lysine ou d'un groupe amino N-terminal et au moins une fraction PEG reliée à un groupe hydroxyle, qui consiste à soumettre le polypeptide à un pH élevé supérieur à 8 pour une période de temps permettant d'éliminer les fractions de PEG liées à un groupe hydroxyle, et à réduire le pH à environ 8 ou moins; ainsi que des polypeptides G-CSF PEGylés et des compositions produites selon le procédé de l'invention et des procédés destinés au augmenter les niveaux neutrophiles chez un patient au moyen des compositions et des polypeptides G-CSF PEGylés.

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