Stabilization of liquid solutions of recombinant protein for...

A - Human Necessities – 61 – K

Patent

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A61K 47/26 (2006.01) A61K 38/37 (2006.01) A61K 47/02 (2006.01) C07K 1/02 (2006.01) A61K 9/08 (2006.01)

Patent

CA 2683317

The invention relates to a method for stabilizing a bulk solution of recombinant protein for frozen storage, which comprises providing a partially-purified solution of recombinant protein which has a monovalent salt concentration of at least 100 mM, and adding a carbohydrate to said solution in an amount sufficient that, upon freezing, the solution has a glass transition temperature of -56 °C or higher.

La présente invention a pour objet un procédé de stabilisation d'une solution en vrac d'une protéine recombinante pour un stockage à l'état congelé, qui comprend l'apport d'une solution partiellement purifiée de la protéine recombinante qui présente une concentration en sel monovalent d'au moins 100 mM et l'addition d'un glucide à ladite solution dans une quantité suffisante pour que, après congélation, la solution ait une température de transition vitreuse de -56 °C ou supérieure.

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