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US 2018/0000933 A1Published application
Stable aqueous anti-vascular endothelial growth factor (vegf) antibody formulation
AssigneePfizer Inc.
InventorsRebecca Lee Ingram, Sarah Elizabeth Weiser
Life of this patent
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Abstract
The present invention relates to the field of pharmaceutical formulations of antibodies. Specifically, the present invention relates to a stable liquid antibody formulation and its pharmaceutical preparation and use. This invention is exemplified by an aqueous formulation of an anti-vascular endothelial growth factor (VEGF) antibody.
Claims24
An aqueous formulation comprising:
- about 25 mg/ml to about 150 mg/ml of an anti-vascular endothelial growth factor (VEGF) antibody;
- a buffer;
- a polyol;
- a surfactant;
- a chelating agent;
- and
- wherein the formulation has a pH at about 5.0 to about 6.0.
4 more elements
An aqueous formulation comprising:
- about 15 mg/ml to about 200 mg/ml of an anti-vascular endothelial growth factor (VEGF) antibody;
- 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 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.
4 more elements
An aqueous formulation comprising:
- about 15 mg/ml to about 150 mg/ml of an anti-vascular endothelial growth factor (VEGF) antibody;
- 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 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 comprises a heavy chain variable region (VH) complementary determining region one (CDR1) having the amino acid sequence shown in SEQ ID NO:
- 1, a VH CDR2 having the amino acid sequence shown in SEQ ID NO:
- 2, a VH CDR3 having the amino acid sequence shown in SEQ ID NO:
- 3, 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.
10 more elements
An aqueous formulation comprising:
- about 25 mg/ml of an anti-vascular endothelial growth factor (VEGF) antibody;
- about 20 mM histidine or succinate buffer;
- about 85 mg/mL sucrose;
- about 0.2 mg/ml polysorbate 80;
- about 0.05 mg/ml EDTA;
- wherein the antibody 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 about 5.5 or 5.8.
7 more elements
Dependencies are inferred from the claim text.