Claims for Patent: 5,099,003

Summary for Patent: 5,099,003

Title:	Method of preparing a sterile plasma-protein solution containing fibrinogen and factor xiii
Abstract:	A method of preparing a sterile and stable plasma-protein solution containing fibrinogen and Factor XIII from human blood plasma which has been stabilized with citrate, comprising treating the plasma with β-propiolactone and irradiating it with ultraviolet light, removing the Factors II, VII, IX and X by adsorption onto anion exchangers that adsorb proteins, precipitating the companion proteins out by adding ethanol until the solution has a final concentration of about 9% by volume at -3° C., centrifuging the precipitate off, dissolving the precipitate in a citrate buffer at a pH of about 6.35 and a temperature of about 37° C., adjusting the protein level of the solution to about 13.3 g/l with sodium citrate solution, adding ethanol, a glycine citrate buffer, and a solution of sodium citrate to precipitate out the companion proteins, adding ethanol to the remaining solution until the solution has a final concentration of about 9% by volume at -3° C., thereby precipitating fribrinogen and Factor XIII, dissolving the precipitate in a citrate buffer at a pH of about 6.35 and a temperature of about 37° C., and filtering the solution.
Inventor(s):	Ronald Kotitschke, Axel W. Stemberger, Wolfgang Stephan
Assignee:	Biotest Pharma GmbH
Application Number:	US07/256,531

Details for Patent 5,099,003

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Csl Behring Gmbh	RIASTAP	fibrinogen concentrate (human)	For Injection	125317	January 16, 2009		2009-03-24