Method for producing factor H from a plasma precipitation fraction

US10183976B2 · kind B2 · utility

Assignee

• Baxalta Incorporated · CH

Inventors

• Ruth Madlener · Wien, AT
• Wolfgang Teschner · Wien, AT
• Hans-Peter Schwarz · Wien, AT
• Sonja Svatos · Ybbs an der Donau, AT
• Azra Pljevljakovic · Wien, AT
• Lena Nitsch · Wien, AT

Key dates

• Filing date: Mar 14, 2014
• Grant date: Jan 22, 2019
• Expiry date: Mar 14, 2034

Classification

• Technology area (CPC A): Human Necessities
• CPC primary: A61K35/16
• WIPO field: Pharmaceuticals
• WIPO sector: Chemistry

Abstract

The present disclosure provides, among other aspects, improved methods for the manufacture of Factor H compositions from plasma precipitation fractions. In some aspects, the methods include an improved process step for extracting Factor H from a plasma precipitate fraction with reduced co-extraction of amidolytic activities. In other aspects, the methods include a heat treatment step for reducing impurities, such as amidolytic enzymes, from a Factor H composition. In yet other aspects, the methods include improved anion exchange, heparin affinity, and/or mixed mode chromatographic enrichment of Factor H. In still other aspects, the improved methods include a combination of the individual improved process steps disclosed herein.