Interferon-beta purification and recovery

Details Interferon-beta purification and recovery Interferon-beta purification and recovery

A - Human Necessities

61

K

A61K 38/21 (2006.01) C07K 1/30 (2006.01) C07K 14/565 (2006.01)

Patent

CA 2427088

Improved methods for purification and recovery of interferon-beta (IFN-.beta.) and compositions comprising substantially monomeric IFN-.beta. are provided. In one purification method, substantially purified IFN-.beta. or variant thereof is precipitated and then dissolved in a guanidine hydrochloride (HC1) solution. Renaturation of the protein occurs by dilution with a suitable buffer. A similar purification method absent the precipitation step is also provided. Following renaturation of the IFN-.beta., residual guanidine HC1 is removed by diafiltration or dialysis with a pharmaceutically acceptable buffer to prepare pharmaceutical compositions comprising substantially monomeric IFN- .beta..

L'invention concerne des méthodes améliorées de récupération et de purification d'interféron-betâ (IFN-.beta.) et des compositions contenant IFN-.beta. pratiquement monomérique. Dans une méthode de purification, on précipite et, puis, on dissout un IFN-.beta. pratiquement purifié ou un variant correspondant dans une solution de chlorhydrate de guanidine (HC1). La renaturation de la protéine se produit par le biais de la dilution avec un tampon approprié. Cette invention concerne aussi une méthode de purification similaire exempte de l'étape de précipitation. Suite à la renaturation de IFN-.beta., on élimine le chlorhydrate de guanidine (HC1) résiduel par diafiltration ou dialyse avec un tampon acceptable pharmaceutiquement de manière à préparer des compositions pharmaceutiques renfermant IFN-.beta. pratiquement monomérique.

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