Stable antibody containing compositions

Patent metadata

Field	Value
Publication number	US-9795674-B2
Application number	US-201113580041-A
Country	US
Kind code	B2
Filing date	Feb 28, 2011
Priority date	Feb 26, 2010
Publication date	Oct 24, 2017
Grant date	Oct 24, 2017

Abstract

The invention relates to stable and low viscous (<50 cP) protein containing compositions, in particular, but not exclusively stable antibody containing compositions and to the use of said stable proteins in therapy, in particular for the subcutaneous delivery of said stable protein.

First claim

The invention claimed is:

1. A stable, liquid composition comprising an anti-TFPI monoclonal antibody, a salt and/or a buffer, wherein the total concentration of said salt and/or buffer is lower than 100 mM and said anti-TFPI antibody is HzTFPI4F36.

2. The composition according to claim 1 , wherein the total concentration of said salt and/or buffer is lower than 60 mM.

3. The composition according to claim 1 , which does not comprise a surfactant.

4. The composition according to claim 1 , wherein the anti-TFPI monoclonal antibody is present within the composition in a concentration of between 100 mg/ml and 300 mg/ml.

5. The composition according to claim 1 , which has a viscosity of 50 cP or less when measured at 25° C.

6. A stable, liquid composition comprising an anti-TFPI monoclonal antibody and arginine, wherein the arginine is present in a concentration of between 5 mM and 100 mM and said anti-TFPI antibody is HzTFPI4F36.

7. The composition according to claim 6 , wherein the concentration of arginine is between 5 mM and 30 mM.

8. The composition according to claim 1 , wherein the anti-TFPI monoclonal antibody is of the IgG4 subtype.

9. A method of treating a coagulopathy which comprises administering to a patient a therapeutically effective amount of a composition according to claim 1 .

10. The method of claim 9 , wherein said coagulopathy is haemophilia A or haemophilia B.

11. The composition according to claim 1 , wherein the anti-TFPI monoclonal antibody protein is present within the composition in a concentration of between 100 mg/ml and 150 mg/ml.

12. The composition according to claim 1 , which has a viscosity of 10 cP or less when measured at 25° C.

13. The composition according to claim 1 , wherein the composition shows a 4.5% or less increase in % HMWP after storage at 40° C. for up to 3 months.

14. The composition according to claim 6 , wherein the composition shows a 4.5% or less increase in % HMWP after storage at 40° C. for up to 3 months.

15. The composition of claim 1 , wherein said anti-TFPI monoclonal antibody is HzTFPI4F36 wherein the concentration of the antibody is at 100 mg/ml.

16. The composition of claim 6 , wherein said anti-TFPI monoclonal antibody is HzTFPI4F36 wherein the concentration of the antibody is at 100 mg/ml.

Assignees

• Parshad Henrik
• Engelund Dorthe Kot
• Gustavsson Malin Therese
• Novo Nordisk As

Inventors

• Parshad Henrik
• Engelund Dorthe Kot
• Gustavsson Malin Therese

Classifications

• A61P7/02

  Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors · CPC title

• A61P7/00

  Drugs for disorders of the blood or the extracellular fluid · CPC title

• A61P7/04

  Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents · CPC title

• A61P37/02

  Immunomodulators · CPC title

• A61P29/00

  Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] · CPC title