Protein formulations comprising gdf-5 in aqueous acidic...

A - Human Necessities – 61 – K

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A61K 38/18 (2006.01) A61K 9/19 (2006.01)

Patent

CA 2695697

Improved compositions and methods are provided for stabilizing a solution of bone morphogenetic protein. The compositions comprise an aqueous solution of GDF-5 and a biocompatible acid, such as hydrochloric, acetic, phosphoric, or trifluoroacetic acid, wherein the solution has a pH of from about 3.0 to about 3.6, thereby providing for improved stability of the GDF-5 protein during handling and prolonged storage at reduced temperatures.

Cette invention a trait à des compositions et à des procédés améliorés permettant de stabiliser une solution de protéine morphogénétique osseuse. Les compositions comprennent une solution aqueuse de protéine GDF-5 et un acide biocompatible, comme l'acide chlorhydrique, l'acide acétique, l'acide phosphorique ou l'acide trifluoroacétique, la solution ayant un pH d'environ 3,0 à environ 3,6, ce qui permet une meilleure stabilité de la protéine GDF-5 lors de sa manipulation et un stockage prolongé à des températures réduites.

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