Anti A Beta Antibody Formulation

A stable formulation, comprising:

• (a) a humanized 3D6 antibody or antigen binding fragment thereof at a concentration of from about 1 mg/ml to about 100 mg/ml, wherein the humanized antibody or antigen binding fragment comprises a light chain variable region having an amino acid sequence as set forth in residues 1-112 of SEQ ID NO:1 and a heavy chain variable region having an amino acid sequence as set forth in residues 1-119 of SEQ ID NO:2;
• (b) histidine at a concentration of from about 5 mM to about 15 mM;
• (c) mannitol in an amount of from about 2% w/v to about 6% w/v;
• (d) methionine at a concentration of from about 5 mM to about 15 mM;
• and
• (e) polysorbate in an amount of from about 0.001% w/v to about 0.01% w/v,
• wherein the formulation has a pH of from about 5.5 to about 6.5.

A stable unit dosage form, comprising:

• (a) a humanized 3D6 antibody or antigen binding fragment thereof in an amount of from about 10 mg to about 250 mg, wherein the humanized antibody or antigen binding fragment comprises a light chain variable region having an amino acid sequence as set forth in residues 1-112 of SEQ ID NO:1 and a heavy chain variable region having an amino acid sequence as set forth in residues 1-119 of SEQ ID NO:2;
• (b) histidine at a concentration of from about 5 mM to about 15 mM;
• (c) mannitol in an amount of from about 2% w/v to about 6% w/v;
• (d) methionine at a concentration of from about 5 mM to about 15 mM;
• and
• (e) polysorbate in an amount of from about 0.001% w/v to about 0.01% w/v,
• at a pH of from about 5.5 to about 6.5.

A pharmaceutical product, comprising:

• (i) a glass vial comprising a stable humanized 3D6 antibody formulation, the formulation comprising:
• (a) a humanized 3D6 antibody or antigen binding fragment thereof in an amount of from about 10 mg to about 250 mg, wherein the humanized antibody or antigen binding fragment comprises a light chain variable region having an amino acid sequence as set forth in residues 1-112 of SEQ ID NO:1 and a heavy chain variable region having an amino acid sequence as set forth in residues 1-119 of SEQ ID NO:2;
• (b) histidine at a concentration of from about 5 mM to about 15 mM;
• (c) mannitol in an amount of from about 2% w/v to about 6% w/v;
• (d) methionine at a concentration of from about 5 mM to about 15 mM;
• and
• (e) polysorbate in an amount of from about 0.001% w/v to about 0.01% w/v,
• wherein the formulation has a pH of from about 5.5 to about 6.5;
• and
• (ii) labeling for use comprising instructions to use the appropriate volume of the antibody formulation necessary to achieve a dose of from about 0.01 mg to about 5 mg per kg of patient body weight.