Stable aqueous antibody formulation for anti tnf alpha antibodies

An aqueous formulation comprising:

• about 35 mg/ml to about 200 mg/ml of an anti-Tumor Necrosis Factor alpha (TNFα) antibody, or an antigen-binding fragment thereof;
• about 1 mM to about 100 mM of a buffer;
• about 1 mg/mL to about 300 mg/mL of a polyol;
• about 0.01 mg/mL to about 10 mg/mL of methionine;
• about 0.01 mg/ml to about 10 mg/ml of a surfactant;
• about 0.001 mg/ml to about 1.0 mg/ml of a chelating agent;
• and
• wherein the formulation has a pH at about 5.0 to about 6.0.

An aqueous formulation comprising:

• about 35 mg/ml to about 200 mg/ml of an anti-Tumor Necrosis Factor alpha (TNFα) antibody, or an antigen-binding fragment thereof;
• about 1 mM to about 100 mM of a buffer;
• about 1 mg/mL to about 300 mg/mL of a polyol;
• about 0.01 mg/mL to about 10 mg/mL of methionine;
• about 0.01 mg/ml to about 10 mg/ml of a surfactant;
• about 0.01 mg/ml to about 1.0 mg/ml of a chelating agent;
• wherein the formulation has a pH at about 5.0 to about 6.0;
• and wherein the antibody, or the antigen-binding fragment thereof, comprises a heavy chain variable region (VH) complementarity determining region one (CDR1) having the amino acid sequence shown in SEQ ID NO:
• 1 or 10, a VH CDR2 having the amino acid sequence shown in SEQ ID NO:
• 2 or 11, a VH CDR3 having the amino acid sequence shown in SEQ ID NO:
• 3 or 12, or a variant of SEQ ID NO:
• 3 having a single alanine substitution at position 2, 3, 4, 5, 6, 8, 9, 10, or 11, or by one to five conservative amino acid substitutions at positions 2, 3, 4, 5, 6, 8, 9, 10, 11, and/or 12, and a light chain variable region (VL) CDR1 having the amino acid sequence shown in SEQ ID NO:
• 4, a VL CDR2 having the amino acid sequence shown in SEQ ID NO:
• 5, and a VL CDR3 having the amino acid sequence shown in SEQ ID NO:
• 6 or 13, or a variant of SEQ ID NO:
• 6 having a single alanine substitution at position 1, 4, 5, 7, or 8, or by one to five conservative amino acid substitutions at positions 1, 3, 4, 6, 7, 8, and/or 9.

An aqueous formulation comprising:

• 50 mg/ml of an anti-Tumor Necrosis Factor alpha (TNFα) protein, or an antigen-binding fragment thereof;
• about 20 mM histidine buffer;
• about 85 mg/mL sucrose;
• about 0.2 mg/mL methionine;
• about 0.2 mg/ml polysorbate 80;
• about 0.05 mg/ml disodium EDTA dihydrate;
• wherein the antibody, or the antigen-binding fragment thereof, comprises a heavy chain variable region comprising the amino acid sequence of SEQ ID NO:
• 7, and a light chain variable region comprising the amino acid sequence of SEQ ID NO:
• 8;
• and
• wherein the formulation has pH at 5.5.