Stabilizing agent for pharmaceutical proteins

Abstract

A method for stabilising a human blood protein or human blood plasma protein with a molecular weight of >10 KDa by adding melezitose to a solution comprising the human blood protein or human blood plasma protein with a molecular weight of >10 KDa.

1 . A composition comprising a human blood protein or human blood plasma protein with a molecular weight of >10 KDa and melezitose. 
     
     
         2 . The composition of  claim 1  in liquid or solid state. 
     
     
         3 . The composition of  claim 1  comprising further a bulking agent, a surfactant, a buffering agent, a further stabilizer and/or tonicity modifier. 
     
     
         4 . The composition of  claim 1 , wherein the protein is factor VIII. 
     
     
         5 . The composition of  claim 1 , wherein the protein is factor IX. 
     
     
         6 . The composition of  claim 1 , wherein the protein is HES-G-CSF. 
     
     
         7 . The composition of  claim 1 , further comprising at least one surface active agent selected from the group consisting of recombinant albumin, Polysorbate 80, Polysorbate 20, and Poloxamer. 
     
     
         8 . The composition of  claim 1 , further comprising at least one buffering agent selected from the group consisting of histidine, sodium citrate, 2-[4-(2-hydroxyethyl)piperazin-1-yl]ethanesulfonic acid (HEPES), Tris, 3-morpholinopropane-1-sulfonic acid (MOPS), and 1,4-Piperazinediethanesulfonic acid (PIPES). 
     
     
         9 . The composition of  claim 1 , further comprising at least one further stabilizer selected from the group consisting of sugars, amino acids, polyols, co-factors and combinations thereof. 
     
     
         10 . The composition of  claim 1 , further comprising at least one tonicity modifier selected from the group consisting of sodium chloride, arginine, glycine, potassium chloride, sugars and sugar alcohols. 
     
     
         11 . The composition of  claim 1 , further comprising at least one bulking agent selected from the group consisting of glycine, mannitol, sodium chloride, arginine and sucrose. 
     
     
         12 . The composition of  claim 1 , wherein the amount of melezitose per amount of the protein is in the range of 50:1 to 150:1 when calculated on a weight by weight basis. 
     
     
         13 . The composition of  claim 1 , wherein the protein is human factor VII protein.