Intravenously administerable polyclonal immunoglobulin preparation containing IgM and method of manufacture

US5190752A · kind A · utility

Assignee

• Biotest Pharma GmbH · DE

Inventors

• Wolfgang Moller · Lübeck, DE
• Hebert Dichtelmuller · Pocking, DE
• Norbert Kothe · Kronberg, DE
• Dieter Rudnick · Dreieich, DE
• Detlef Piechaczek · Munster, DE

Key dates

• Filing date: Jul 14, 1989
• Grant date: Mar 2, 1993
• Expiry date: Jul 14, 2009

Classification

• Technology area (CPC Y): Emerging Cross-Sectional Technologies
• CPC primary: Y10S530/863
• WIPO field: Pharmaceuticals
• WIPO sector: Chemistry

Abstract

An intravenously administrable polyclonal immunoglobulin preparation for the treatment and prophylaxis of bacterial infections containing at least 50% by weight of IgM in terms of the total content of immunoglobulin, exhibiting a low anticomplementary activity, being stable in aqueous solution, and being free of viruses. It can also consist of or also contain a mixture of several monoclonal IgM antibodies. The source material for its manufacture is an immunoglobulin-containing fraction of human, animal, or bacterial provenance. The fraction is treated with an anion exchanger that is eluted with a saline or pH gradient and the eluate is optionally subjected to gel filtration, treated before or after the chromatography with .beta.-propiolactone and PEG 4000, and optionally heated. Treatment with .beta.-propiolactone and ultraviolet light, treatment with solvents and detergents, or pasteurization can also be conducted. Proteins, sugars, or mixtures of amino acids are optionally added to the preparation.