PURIFIED ANTIBODY COMPOSITION
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.