Method of producing a virus safe, storage-stable, and intravenously tolerable immunoglobulin-G preparation

US4877866A · kind A · utility

Assignee

• Biotest Pharma GmbH · DE

Inventors

• Dieter Rudnick · Dreieich, DE
• Norbert Kothe · Kronberg, DE
• Herbert Dichtelmuller · Pocking, DE
• Detlef Piechaczek · Munster, DE
• Wolfgang Stephan · Heidelberg, DE
• Hans Schleussner · Frankfurt, DE

Key dates

• Filing date: Nov 18, 1987
• Grant date: Oct 31, 1989
• Expiry date: Nov 18, 2007

Classification

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

Abstract

A method of producing a virus-safe, storage-stable, and intravenously tolerable immunoglobulin-G preparation. The object is to make the method appropriate for industrial-scale production and economical by means of the enrichment and multistage purification of a plasma that has had the coagulation factors removed from it or of a plasma fraction or serum fraction that contains immunoglobulin G accompanied by treatment with ion exchangers and by ultrafiltration. The precipitant is eliminated, by means of diafiltration or gelfiltration, either from the plasma that has had the coagulation factors removed from it or from the plasma fraction that contains the immunoglobulin G, and the desired ion composition is established. The resulting protein solution is subjected to fractionation over an ion exchanger to separate the immunoglobulin G. The proteolytic enzymes in the resulting immunoglobulin-G solution are removed by means of affinity chromatography over a dye linked sorbent and/or are ihibited by the addition of antithrombin III. The accordingly stabilized immunoglobulin-G solution is treated, at a protein concentration of 20 to 60 g/l and a pH 6.0 to 8.0, with 0.03 to 0.07% of .beta.-…