Purified antibody composition

Abstract

The invention provides a method for producing a host cell protein-(HCP) reduced antibody preparation from a mixture comprising an antibody and at least one HCP, comprising an ion exchange separation step wherein the mixture is subjected to a first ion exchange material, such that the HCP-reduced antibody preparation is obtained.

1 . A method for producing a host cell protein-(HCP) reduced antibody preparation from a mixture comprising an antibody and at least one HCP, the method comprising:
 (a) applying the mixture to a first ion exchange resin in an equilibration buffer, wherein greater than 30 grams of antibody per liter of resin are applied;   (b) washing HCP from the resin with a plurality of wash steps; and   (c) eluting the antibody from the resin with an elution buffer to form a first eluate, such that the HCP-reduced antibody preparation is obtained.   
     
     
         2 . The method of  claim 1 , wherein about 35-70 grams of antibody per liter of resin are applied. 
     
     
         3 . The method of  claim 1 , wherein about 70 grams of antibody per liter of resin are applied. 
     
     
         4 . The method of  claim 1 , wherein the mixture comprising an antibody and at least one HCP is not subjected to protein A capture prior to applying the mixture to the first ion exchange resin. 
     
     
         5 . The method of  claim 1 , wherein the plurality of wash steps comprises at least a first wash and a second wash, wherein there is an increase in conductivity from the first wash to the second wash. 
     
     
         6 .- 58 . (canceled) 
     
     
         59 . An antibody preparation which is substantially free of HCP as measured by a HCP ELISA produced using the method of  claim 1 . 
     
     
         60 . A pharmaceutical composition comprising an HCP-reduced antibody preparation produced using the method of  claim 1 , and a pharmaceutically acceptable carrier. 
     
     
         61 . A pharmaceutical composition comprising an HCP-reduced antibody, wherein the level of HCP comprises no greater than about 70 ng of HCP per mg of antibody as measured by a HCP ELISA, and a pharmaceutically acceptable carrier. 
     
     
         62 . The pharmaceutical composition of  claim 61 , wherein the level of HCP comprises no greater than about 13 ng of HCP per mg of antibody as measured by a HCP ELISA. 
     
     
         63 . The pharmaceutical composition of  claim 61 , wherein the level of HCP comprises no greater than about 5 ng of HCP per mg of antibody as measured by a HCP ELISA. 
     
     
         64 . A composition comprising an antibody, wherein said composition has no detectable level of HCP as determined by a HCP ELISA assay. 
     
     
         65 . An antibody preparation which is substantially free of procathepsin L produced using the method of  claim 1 . 
     
     
         66 . A pharmaceutical composition comprising a procathepsin L-reduced antibody preparation produced using the method of  claim 1 , and a pharmaceutically acceptable carrier. 
     
     
         67 . A pharmaceutical composition comprising an antibody a procathepsin L-reduced antibody and a pharmaceutically acceptable carrier, wherein the level of procathepsin L is no greater than a cathepsin activity of about 3.0 RFU/s/mg of antibody. 
     
     
         68 . The composition or preparation of  claim 67 , wherein the antibody is an anti-tumor necrosis factor-alpha (TNFα) antibody, or antigen-binding portion thereof. 
     
     
         69 . A method of treating a disorder in which TNFα activity is detrimental comprising administering to a human subject the composition or preparation of  claim 68 . 
     
     
         70 . An article of manufacture comprising a packaging material, adalimumab, and a label or package insert contained within the packaging material indicating that the adalimumab formulation comprises no greater than about 70 ng of HCP per mg of adalimumab. 
     
     
         71 . The article of manufacture of  claim 70 , wherein the label or package insert indicates that the adalimumab formulation comprises no greater than about 13 ng of HCP per mg of adalimumab. 
     
     
         72 . The article of manufacture of  claim 70 , wherein the label or package insert indicates that the adalimumab formulation comprises no greater than about 5 ng of HCP per mg of adalimumab. 
     
     
         73 . An article of manufacture comprising a packaging material, adalimumab, and a label or package insert contained within the packaging material indicating that the adalimumab formulation comprises no greater a level of procathepsin L than that indicated by a cathepsin L activity of about 3.0 RFU/s/mg adalimumab.