A METHOD OF VIRUS INACTIVATION IN COMPOSITION COMPRISING FACTOR VII

• US 20150359859A1
• Filed: 02/03/2014
• Published: 12/17/2015
• Est. Priority Date: 01/31/2013
• Status: Abandoned Application

• Current Assignee: Hanmi Pharmaceutical Company Limited
• Original Assignee: Hanmi Pharmaceutical Company Limited
• Inventors: KIM, Dae Jin, KIM, Seung Su, HWANG, Sang Youn, CHOI, In Young, KWON, Se Chang, LEE, Byung Sun
• Application Number:
  US14/764,454
• Publication Number:
  US 20150359859A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 38/4846 Factor VII (3.4.21.21); Factor IX (3.4.21.22); Factor Xa (3.4.21.6); Factor XI (3.4.21.27); Factor XII (3.4.21.38)
• CPC Class Codes: A61L 2/16 using chemical substances
• CPC Class Codes: A61P 31/12 Antivirals
• CPC Class Codes: A61P 7/00 Drugs for disorders of the blood or the extracellular fluid
• CPC Class Codes: A61P 7/04 Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
• CPC Class Codes: C12Y 304/21021 Coagulation factor VIIa (3.4.21.21)

Abstract

The present invention relates to a method for inactivating viruses in a composition comprising blood coagulation factor VII, and more particularly, to a method for inactivating viruses comprising adding a surfactant to a composition comprising blood coagulation factor VII or a derivative thereof and a method for preparing a virus-inactivated composition comprising blood coagulation factor VII or the derivative thereof.

Claims

1. A method for inactivating viruses, comprising adding a surfactant to a composition comprising blood coagulation factor VII or a derivative thereof.

2. The method according to claim 1, wherein the content of the activated blood coagulation factor VII or derivative thereof in the composition is less than 5%, based on the total blood coagulation factor VII or derivative thereof.

3. The method according to claim 1, wherein the composition is a liquid composition.

4. The method according to claim 3, wherein the liquid composition has pH 5.0 to 8.0.

5. The method according to claim 3, wherein the composition has a temperature of 4 to 25°

C.

6. The method according to claim 1, wherein the concentration of the blood coagulation factor VII or the derivative thereof in the composition is 0.01 mg/mL to 5.0 mg/mL.

7. The method according to claim 1, wherein the surfactant is selected from the group consisting of Tween, polysorbate 20, polysorbate 60, polysorbate 80, ploxamer188, Triton X-100, and combinations thereof.

8. The method according to claim 1, wherein the surfactant is added at a final concentration of 0.01 to 1.00%(w/v).

9. The method according to claim 8, wherein the surfactant is added at a final concentration of 0.1 to 0.5%(w/v).

10. The method according to claim 1, wherein the blood coagulation factor VII derivative is prepared by linking a peptide linker to the C-terminus of blood coagulation factor VII.

11. The method according to claim 10, wherein the peptide linker has cysteine as the final amino acid residue of the C-terminus.

12. The method according to claim 10, wherein the peptide linker has one peptide sequence selected from the group consisting of SEQ ID NOs. 3 and 6 to 12.

13. A method for preparing a virus-inactivated composition comprising blood coagulation factor VII or a derivative thereof, comprising adding a surfactant to the composition comprising blood coagulation factor VII or the derivative thereof.