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 .- 67 . (canceled) 
     
     
         68 . A pharmaceutical composition comprising an isolated human anti-TNFα antibody that
 comprises a light chain variable region comprising a light chain CDR3 domain comprising the amino acid sequence of SEQ ID NO: 3; a light chain CDR2 domain comprising the amino acid sequence of SEQ ID NO: 5; and a light chain CDR1 domain comprising the amino acid sequence of SEQ ID NO: 7; and 
 comprises a heavy chain variable reason comprising a heavy chain CDR3 domain comprising the amino acid sequence of SEQ ID NO: 4; a heavy chain CDR2 domain comprising the amino acid sequence of SEQ ID NO: 6; and a heavy chain CDR1 domain comprising the amino acid sequence of SEQ ID NO: 8, 
 
       and a pharmaceutically acceptable carrier, wherein the composition contains a level of HCP no greater than about 70 ng of HCP per mg of antibody as measured by an HCP ELISA and a cathepsin L activity of no greater than about 3.0 RFU/s/mg antibody. 
     
     
         69 . The pharmaceutical composition of  claim 68 , wherein the composition comprises no greater than 13 ng of HCP per mg of antibody, or antigen-binding portion thereof. 
     
     
         70 . The pharmaceutical composition of  claim 68 , wherein the composition comprises no greater than 5 ng of HCP per mg of antibody, or antigen-binding portion thereof. 
     
     
         71 . The pharmaceutical composition of  claim 68 , wherein the composition has a concentration of antibody, or antigen-binding portion thereof, of 50 mg/mL. 
     
     
         72 . A pharmaceutical composition comprising an isolated human anti-TNFα antibody that comprises a light chain variable region (LCVR) comprising the amino acid sequence of SEQ ID NO: 1, and a heavy chain variable region (HCVR) comprising the amino acid sequence of SEQ ID NO: 2, and a pharmaceutically acceptable carrier, wherein the composition contains a level of HCP no greater than about 70 ng of HCP per mg of antibody as measured by an HCP ELISA and a cathepsin L activity of no greater than about 3.0 RFU/s/mg antibody. 
     
     
         73 . The pharmaceutical composition of  claim 72 , wherein the composition comprises no greater than 13 ng of HCP per mg of antibody, or antigen-binding portion thereof. 
     
     
         74 . The pharmaceutical composition of  claim 72 , wherein the composition comprises no greater than 5 ng of HCP per mg of antibody, or antigen-binding portion thereof. 
     
     
         75 . The pharmaceutical composition of  claim 72 , wherein the composition has a concentration of antibody, or antigen-binding portion thereof, of 50 mg/mL. 
     
     
         76 . A pharmaceutical composition comprising an isolated human anti-TNFα antibody which is adalimumab, or an antigen-binding portion thereof, wherein the composition contains a level of HCP no greater than about 70 ng of HCP per mg of antibody as measured by an HCP ELISA and a cathepsin L activity of no greater than about 3.0 RFU/s/mg antibody. 
     
     
         77 . The pharmaceutical composition of  claim 76 , wherein the composition comprises no greater than 13 ng of HCP per mg of antibody, or antigen-binding portion thereof. 
     
     
         78 . The pharmaceutical composition of  claim 76 , wherein the composition comprises no greater than 5 ng of HCP per mg of antibody, or antigen-binding portion thereof. 
     
     
         79 . The pharmaceutical composition of  claim 76 , wherein the composition has a concentration of antibody, or antigen-binding portion thereof, of 50 mg/mL.