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Last Updated: April 18, 2024

Claims for Patent: 5,714,370


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Summary for Patent: 5,714,370
Title: Thrombin and method of producing the same
Abstract:A thrombin of human or animal origin is free of infectious agents and is produced by activation of prothrombin subjected to a heat treatment for the inactivation of infectious agents.
Inventor(s): Eibl; Johann (Vienna, AT), Linnau; Yendra (Vienna, AT)
Assignee: Immuno Aktiengesellschaft (Vienna, AT)
Application Number:08/458,082
Patent Claims:1. A pharmaceutical preparation comprising (i) a virus-safe human or animal thrombin and (ii) a coagulatively active salt, wherein the thrombin is obtained from a virus-inactivated prothrombin-containing plasma fraction by exclusive activation with the coagulatively active salt.

2. The preparation according to claim 1, wherein the fraction comprises a prothrombin complex.

3. The preparation according to claim 2, wherein the prothrombin complex is activated.

4. The preparation according to claim 1, wherein the fraction comprises Factor VIII Inhibitor Bypassing Activity (FEIBA).

5. A pharmaceutical preparation comprising a virus-safe human or animal thrombin, wherein the thrombin is obtained from a virus-inactivated prothrombin-containing fraction by exclusive activation with a coagulatively active salt.

6. The preparation according to claim 5, wherein the fraction comprises a prothrombin complex.

7. The preparation according to claim 6, wherein the prothrombin complex is activated.

8. The preparation according to claim 5, wherein the fraction comprises FEIBA.

9. A method for producing a pharmaceutical preparation comprising (i) virus-safe thrombin of human or animal origin and (ii) a coagulatively active salt, comprising

(a) preparing an activated prothrombin complex from a prothrombin-containing plasma fraction;

(b) treating the activated prothrombin complex to inactivate contaminating viruses;

(c) contacting the treated activated prothrombin complex with a coagulatively active salt to generate thrombin; and

(d) preparing the pharmaceutical preparation with the generated thrombin.

10. The method according to claim 9, wherein the preparing comprises purifying thrombin by at least one method selected from the group consisting of ion exchange chromatography and affinity chromatography.

11. A method for producing a preparation comprising (i) virus-safe human or animal thrombin and (ii) a coagulatively active salt, comprising

(a) treating an activated human or animal prothrombin complex to inactivate contaminating viruses;

(b) contacting the treated activated prothrombin complex with a coagulatively active salt to generate virus-safe thrombin; and

(c) formulating the preparation with the virus-safe thrombin from (b).

12. The method according to claim 11, further comprising purifying the generated virus-safe thrombin prior to (c) by at least one method selected from the group consisting of ion exchange chromatography and affinity chromatography to yield purified virus-safe thrombin.

13. A pharmaceutical preparation comprising a virus-safe human or animal thrombin, wherein the thrombin is obtained from a virus-inactivated prothrombin-containing fraction by the sole addition of a coagulatively active salt for activation.

14. The preparation according to claim 13, further comprising the coagulatively active salt.

Details for Patent 5,714,370

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Baxalta Us Inc. AUTOPLEX, FEIBA NF, FEIBA VH anti-inhibitor coagulant complex For Injection 101447 12/21/1979 ⤷  Try a Trial 2015-02-03
Baxalta Us Inc. AUTOPLEX, FEIBA NF, FEIBA VH anti-inhibitor coagulant complex For Injection 101447 07/31/2000 ⤷  Try a Trial 2015-02-03
Baxalta Us Inc. AUTOPLEX, FEIBA NF, FEIBA VH anti-inhibitor coagulant complex For Injection 101447 08/11/2005 ⤷  Try a Trial 2015-02-03
Omrix Biopharmaceuticals Ltd EVITHROM thrombin, topical (human) Solution 125247 08/27/2007 ⤷  Try a Trial 2015-02-03
Omrix Biopharmaceuticals Ltd EVITHROM thrombin, topical (human) For Injection 125247 09/17/2009 ⤷  Try a Trial 2015-02-03
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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