Claims for Patent: 4,687,664

Summary for Patent: 4,687,664

Title:	Method of inactivating reproducible pathogens
Abstract:	There is described a method of inactivating reproducible pathogens in preparations containing plasmatic enzymes and proenzymes, activated or non-activated coagulation factors, such as Factors II, V, VII, VIII, IX, X, XIII, \"FEIBA\", prothrombin complex preparations, plasmatic inhibitors, immunoglobulins or other blood products, such as fibronectin and fibrinogen. In order to break and overcome the protective effect of proteins on pathogens by simultaneously preserving the biological activity and the molecular integrity of the proteins, the preparation is adjusted to a salt concentration of more than 0.5 molar by the addition of ammonium sulfate and is thermally treated, whereupon the ammonium sulfate is removed from the preparation.
Inventor(s):	Philapitsch; Anton (Ebenfurt, AT), Wober; Gunter (Oberwaltersdorf, AT), Eibl; Johann (Vienna, AT), Schwarz; Otto (Vienna, AT)
Assignee:	Immuno Aktiengesellschaft fur chemisch-medizinische Produkte (Vienna, AT)
Application Number:	06/605,658
Patent Claims:	1. A method of inactivating reproducible pathogens in a preparation containing plasmatic enzymes on proenzymes, activated or non-activated coagulation factors, prothrombin complex preparations, plasmatic inhibitors, immunoglobulins or other blood products comprising adding ammonium sulfate to said preparation to attain a salt concentration of more than 0.5 molar, thermally treating said preparation for a period of time sufficient to inactivate the pathogens and removing said ammonium sulfate from said preparation. 2. A method as set forth in claim 1, wherein said preparation has a protein content of from 0.001% to 30%. 3. A method as set forth in claim 1, wherein said preparation having a 2 to 4 molar ammonium sulfate concentration is thermally treated. 4. A method as set forth in claim 1, wherein a protein and ammonium sulfate containing precipitate is recovered from said preparation by adding ammonium sulfate, and said precipitate is thermally treated. 5. A method as set forth in claim 1, wherein said preparation is lyophilized after adding said ammonium sulfate so as to obtain a lyophilisate which is then thermally treated, and an aqueous solvent is added to said thermally treated lyophilisate so as to reconstitute a solution from which said ammonium sulfate is removed. 6. A method as set forth in claim 1, wherein said thermal treatment is carried out during a period of from 1 second to 100 hours and at a temperature of from 40.degree. C. to 121.degree. C. 7. A method as set forth in claim 1, wherein the pH of said preparation during treatment is maintained in a range of from 5 to 11. 8. A method as set forth in claim 7, wherein the pH of said preparation is maintained in a range of from 6.5 to 8.5. 9. A method as set forth in claim 1, wherein protein stabilizing substances are added to said preparation prior to said thermal treatment. 10. A method as set forth in claim 9, wherein said protein stabilizing substance is glycine. 11. A method as set forth in claim 1, wherein antimicrobial substances are added to said preparation prior to said thermal treatment. 12. A method as set forth in claim 11, wherein said antimicrobial substance is caprylate. 13. A method as set forth in claim 1, wherein said removal of ammonium sulfate from said preparation is effected by means of semi-permeable membranes. 14. A method as set forth in claim 1 wherein said activated or non-activated coagulation factors include Factors II, V, VII, VIII, IX, X, XIII and "FEIBA". 15. A method as set forth in claim 1 wherein said other blood products include fibronectin and fibrinogen.

Details for Patent 4,687,664

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		2004-08-18
Baxalta Us Inc.	AUTOPLEX, FEIBA NF, FEIBA VH	anti-inhibitor coagulant complex	For Injection	101447	07/31/2000		2004-08-18
Baxalta Us Inc.	AUTOPLEX, FEIBA NF, FEIBA VH	anti-inhibitor coagulant complex	For Injection	101447	08/11/2005		2004-08-18