Method of preparing a sterile plasma-protein solution containing fibrinogen and Factor XIII

US5099003A · kind A · utility

Assignee

• Biotest Pharma GmbH · DE

Inventors

• Ronald Kotitschke · Dreieich, DE
• Axel Stemberger · Neubiberg, DE
• Wolfgang Stephan · Heidelberg, DE

Key dates

• Filing date: Oct 12, 1988
• Grant date: Mar 24, 1992
• Expiry date: Oct 12, 2008

Classification

• Technology area (CPC A): Human Necessities
• CPC primary: A61K38/00
• WIPO field: Pharmaceuticals
• WIPO sector: Chemistry

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 .beta.-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.degree. 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.degree. 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.degree. 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.degree. C., and filtering the solution.