Claims for Patent: 5,281,661

Summary for Patent: 5,281,661

Title:	Complex containing coagulation factor IX
Abstract:	Factor IX is selectively adsorbed by means of hydrophobic chromatography from an aqueous mixture containing at least one plasma zymogen or a vitamin-K dependent protein in addition to factor IX. By this method, the efficient enrichment of factor IX for the production of pharmaceutical preparations has become possible.
Inventor(s):	Linnau; Yendra (Vienna, AT), Sazgary; Maria (Vienna, AT)
Assignee:	Immuno Aktiengesellschaft (Vienna, AT)
Application Number:	07/822,996
Patent Claims:	1. A method for producing a coagulation factor IX complex including a carrier based on a polymer containing hydrophobic groups, to which factor IX is selectively bound from an aqueous mixture containing at least one plasma zymogen in addition to factor IX, which method comprises the steps of preparing said aqueous mixture having a conductivity of at least 30 mS, and contacting said aqueous mixture with said carrier based on a polymer containing hydrophobic groups so as to complex factor IX. 2. A method as set forth in claim 1, further comprising washing said complexed factor IX. 3. A method as set forth in claim 1, further comprising subjecting said complexed factor IX to inactivation of possibly present infectious agents. 4. A method as set forth in claim 1, wherein said aqueous mixture has a conductivity ranging between 60 and 120 mS. 5. A method as set forth in claim 1, wherein complexing of said factor IX is carried out in the presence of a detergent. 6. A method for producing a pharmaceutical preparation containing coagulation factor IX, which method comprises the steps of providing a coagulation factor IX complex including a carrier based on a polymer containing hydrophobic groups, to which factor IX is selectively bound from an aqueous mixture containing at least one plasma zymogen in addition to factor IX, eluting factor IX from said factor IX complex so as to obtain a factor IX containing eluate, and processing said factor IX containing eluate to a pharmaceutical preparation. 7. A method as set forth in claim 6, wherein said elution is carried out at a conductivity maximally lying by 20% below that of said factor IX containing aqueous mixture. 8. A method according to the method of claim 6 wherein the aqueous mixture containing at least one plasma zymogen in addition to factor IX is obtained by the steps of: providing plasma or a factor IX containing plasma fraction, subjecting the plasma to a first anion exchange chromatography, thus binding factor IX and the at least one plasma zymogen to the first anion exchange chromatography eluting the bound factor IX and the at least one plasma zymogen from the first anion exchange chromatography so as to obtain a first eluate containing factor IX and the at least one plasma zymogen subjecting the first eluate to a second anion exchange chromatography in the presence of a detergent, thus binding factor IX and the at least one plasma zymogen to the second anion exchange chromatography, eluting the bound factor IX and the at least one plasma zymogen from the second anion exchange chromatography so as to obtain a second eluate containing in an aqueous mixture factor IX and the at least one plasma zymogen, and subjecting the second eluate to an inactivation of possibly present infectious agents.

Details for Patent 5,281,661

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Grifols Biologicals Llc	PROFILNINE, PROFILNINE HP, PROFILNINE HT, PROFILNINE SD	factor ix complex	For Injection	102476	July 20, 1981		2011-01-25