Process for preparing gamma globulin suitable for intravenous administration using peg and a citrate buffer

US4835257A · kind A · utility

Assignee

• Armour Pharma GmbH · DE

Inventors

• Jurgen-Dietrich Friedrich-Fiechtl · Witzenhausen, DE
• Bernhard Kerner · Munster, DE
• Jurgen Holzapfel · Treffurt, DE
• Martin Puschmann · Bensberg, DE
• Tokusuke Kimura · Tokyo, JP
• Fumio Kurosu · Chigasaki, JP

Key dates

• Filing date: Nov 19, 1987
• Grant date: May 30, 1989
• Expiry date: Nov 19, 2007

Classification

• Technology area (CPC Y): Emerging Cross-Sectional Technologies
• CPC primary: Y10S530/831
• WIPO field: Pharmaceuticals
• WIPO sector: Chemistry

Abstract

An improved process for the preparation of gamma globulin suitable for intravenous administration comprises dissolving gamma globulin precipitated from blood or blood products in a solution, separating non-dissolved precipitate from the solution, adding polyethylene glycol to the separated solution, separating precipitate from the polyethylene glycol solution, increasing the polyethylene glycol concentration in the solution, separating precipitated purified gamma globulin from the higher concentrated polyethylene glycol solution, dissolving the purified gamma globulin in a solution suitable for intravenous administration, which process is improved by dissolving the gamma globulin precipitated from blood in a solution having a neutral pH, adding polyethylene glycol in the first step to a concentration of 4.0-5.5% by weight, and increasing the polyethylene glycol concentration in the second step to at least 9% but not more than 16% by weight, and by adding a buffer to the solution just prior to adding the polyethylene glycol in one of the two polyethylene glycol addition steps.