Stabilised Protein Solutions

Abstract

The invention relates to a method of stabilizing highly concentrated protein solutions during ultrafiltration by addition of sucrose to the highly concentrated protein solution, in particular, but not exclusively to a method of stabilizing highly concentrated antibody solutions during ultrafiltration by addition of sucrose to the highly concentrated antibody solution.

1 . A method of ultrafiltration of a highly concentrated protein solution, wherein sucrose is added to the solution when the protein concentration of the solution is between 40 and 60 g/L before further concentration by ultrafiltration. 
     
     
         2 . The method according to  claim 1 , wherein the difference between the calculated protein concentration and the measured protein concentration in the highly concentrated ultrafiltration retentate is decreased. 
     
     
         3 . The method according to  claim 1 , wherein the difference between the calculated protein concentration and the measured protein concentration in the highly concentrated ultrafiltration retentate is less than 30%. 
     
     
         4 . The method according to  claim 1 , wherein the addition of sucrose stabilizes the highly concentrated solution to be ultrafiltrated. 
     
     
         5 . The method according to  claim 1 , wherein the level of HMWP aggregates is 1% or below 1% in the highly concentrated ultrafiltration retentate. 
     
     
         6 . The method according to  claim 1 , wherein the recovery of the protein during ultrafiltration is increased. 
     
     
         7 . The method according to  claim 1 , wherein the recovery of the protein during ultrafiltration is 94% or above, of the total amount of protein in the highly concentrated protein solution to be ultrafiltrated. 
     
     
         8 . The method according to  claim 1 , wherein the sucrose is added to the highly concentrated protein solution in the concentration of between 50 mM and 300 mM. 
     
     
         9 . The method according to  claim 1 , wherein the protein is an antibody. 
     
     
         10 . The method according to  claim 1 , wherein the antibody is a monoclonal antibody. 
     
     
         11 . The method according to  claim 10 , wherein the antibody is an anti-IL-20 monoclonal antibody. 
     
     
         12 . The method according to  claim 2 , wherein the difference between the calculated protein concentration and the measured protein concentration in the highly concentrated ultrafiltration retentate is less than 30%. 
     
     
         13 . A pharmaceutical composition comprising a protein or an antibody concentrated from a protein or antibody solution by using the method of  claim 1 . 
     
     
         14 . A method of treating an inflammatory disease which comprises administering to a patient the pharmaceutical composition of  claim 13 .