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US 12,708,668 B2Granted
Stable aqueous anti-TFPI antibody formulation
AssigneePfizer Inc.
InventorsThomas Joseph Crowley, Robert Lee Dufield, Jennifer Juneau
Life of this patent
Estimating the term…
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-Tissue Factor Pathway Inhibitor (TFPI) antibody.
Claims18
A stable pharmaceutical formulation consisting of:
- about 100 mg/mL to about 150 mg/mL of an antibody that specifically binds to an epitope in Kunitz Domain 2 (K2) of Tissue Factor Pathway Inhibitor (TFPI), about 20 mM histidine buffer, about 85 mg/mL sucrose, about 0.2 mg/mL polysorbate 80 and about 0.05 mg/mL disodium edetate dihydrate (EDTA), wherein the formulation has a pH at about 5.8, wherein the histidine buffer comprises L-histidine, L-histidine monohydrochloride or a mixture thereof, and wherein the antibody comprises:
- (i) a heavy chain variable region (VH) comprising:
- (a) a VH complementarity determining region one (CDR-H1) comprising the amino acid sequence of SEQ ID NO:
- 13;
- (b) a VH complementarity determining region two (CDR-H2) comprising the amino acid sequence of SEQ ID NO:
- 14;
- and (c) a VH complementarity determining region three (CDR-H3) comprising the amino acid sequence of SEQ ID NO:
- 15, and
- (ii) a light chain variable region (VL) comprising:
- (a) a VL complementarity determining region one (CDR-L1) comprising the amino acid sequence of SEQ ID NO:
- 8;
- (b) a VL complementarity determining region two (CDR-L2) comprising the amino acid sequence of SEQ ID NO:
- 9;
- and (c) a VL complementarity determining region three (CDR-L3) comprising the amino acid sequence of SEQ ID NO:
- 10.
12 more elements
A stable pharmaceutical formulation consisting of:
- 150 mg/mL of an antibody that specifically binds to an epitope in Kunitz Domain 2 (K2) of Tissue Factor Pathway Inhibitor (TFPI), 20 mM histidine buffer, 85 mg/mL sucrose, 0.2 mg/mL polysorbate 80, and 0.05 mg/mL disodium edetate dihydrate, wherein the histidine buffer comprises L-histidine, L-histidine monohydrochloride or a mixture thereof, wherein the antibody comprises a heavy chain variable region comprising the amino acid sequence of SEQ ID NO:
- 18, and a light chain variable region comprising the amino acid sequence of SEQ ID NO:
- 11, and wherein the formulation has a pH of 5.8.
A stable pharmaceutical formulation consisting of:
- 150 mg/mL of an antibody that specifically binds to an epitope in Kunitz Domain 2 (K2) of Tissue Factor Pathway Inhibitor (TFPI), 20 mM histidine buffer, 85 mg/mL sucrose, 0.2 mg/mL polysorbate 80, and 0.05 mg/mL disodium edetate dihydrate, wherein the histidine buffer comprises L-histidine, L-histidine monohydrochloride or a mixture thereof, wherein the antibody comprises a heavy chain comprising the amino acid sequence of SEQ ID NO:
- 19, and a light chain comprising the amino acid sequence of SEQ ID NO:
- 12, and wherein the formulation has a pH of 5.8.
A stable pharmaceutical formulation consisting of:
- 150 mg/mL of an antibody that specifically binds to an epitope in Kunitz Domain 2 (K2) of Tissue Factor Pathway Inhibitor (TFPI), 20 mM histidine buffer, 85 mg/mL sucrose, 0.2 mg/mL polysorbate 80, and 0.05 mg/mL disodium edetate dihydrate, wherein the histidine buffer comprises L-histidine, L-histidine monohydrochloride or a mixture thereof, wherein the antibody comprises a heavy chain comprising the amino acid sequence of SEQ ID NO:
- 17, and a light chain comprising the amino acid sequence of SEQ ID NO:
- 12, and wherein the formulation has a pH of 5.8.
Dependencies are inferred from the claim text.