Method for the preparation of growth hormone and antagonist...

Details Method for the preparation of growth hormone and antagonist... Method for the preparation of growth hormone and antagonist...

C - Chemistry, Metallurgy

07

K

C07K 1/00 (2006.01) C07K 1/113 (2006.01) C07K 1/18 (2006.01) C07K 14/575 (2006.01) C07K 14/61 (2006.01)

Patent

CA 2497146

The present invention is directed generally to recombinant methods for making a desired polypeptide. These method(s) yield a polypeptide product containing reduced levels of isoform impurities thereof. In particular, the present invention is directed to (1) a recombinant method for preparing growth hormone with reduced isoform impurities thereof and (2) a recombinant method for preparing a growth hormone antagonist, such as pegvisomant, and its protein intermediate, also having reduced isoform impurities thereof. More specifically, the isoform impurities that are decreased by methods of the present invention are the trisulfide and des-phe isoform impurities of growth hormone and growth hormone antagonist (or its intermediate), respectively.

L'invention concerne, en général, des méthodes de recombinaison permettant de préparer un polypeptide désiré. Cette ou ces méthode(s) permettent d'obtenir un produit polypeptidique contenant des niveaux d'impuretés isoformes réduits. L'invention concerne, en particulier, 1) une méthode de recombinaison permettant de préparer une hormone de croissance à niveaux d'impuretés isoformes réduits, et 2) une méthode de recombinaison permettant de préparer un antagoniste d'hormone de croissance, tel que le pegvisomant et son intermédiaire protéique, présentant également des niveaux d'impuretés isoformes réduits. De manière plus spécifique, les impuretés isoformes réduites au moyen des méthodes de l'invention sont respectivement les impuretés isoformes de trisulfure et des-phe d'hormone de croissance et d'antagoniste (ou de ses intermédiaires) d'hormone de croissance.

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