A novel process for purification of human growth harmone

C - Chemistry – Metallurgy – 07 – K

Patent

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C07K 14/61 (2006.01) C07K 1/20 (2006.01)

Patent

CA 2565209

The present invention relates to a commercial process for purification of human Growth hormone obtained by DNA recombinant technique using hydrophobic interactive chromatography, efficient to separate clipped molecules of human growth hormone present as an impurity arising due to clipping positions present on the megamolecule of human growth hormone from the target human growth hormone molecule using a phenyl column, mixture of aqueous buffers and organic solvents as an eluant, followed by desalting, lypholization and the invention also relates to the process wherein the elution of clipped molecules of human growth hormone precedes the elution of target human growth hormone to obtain hGH of purity > 99.5%.

La présente invention concerne un procédé industriel pour la purification d'une hormone de croissance humaine, obtenue par une technique d'ADN recombiné, utilisant la chromatographie hydrophobe, efficace pour séparer de la molécule d'hormone de croissance humaine cible les molécules tronquées d'hormone de croissance humaine présentes en tant qu'impureté survenant à cause de positions de troncage présentes sur la mégamolécule de l'hormone de croissance humaine, laquelle chromatographie utilise une colonne à groupes phényles, un mélange de tampons aqueux et de solvants organiques comme éluant et est suivie d'un dessalage et d'une lyophilisation; l'invention concerne également le procédé dans lequel l'élution de molécules tronquées de l'hormone de croissance humaine précède l'élution de l'hormone de croissance humaine cible pour obtenir une hGH ayant une pureté supérieure à 99,5 %.

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