Baxalta Gmbh

Baxter International Inc.

Baxter Healthcare Sa

Takeda Pharmaceutical Company Limited

Ruth Madlener

Hans-Peter Schwarz

Wolfgang Teschner

Azra Pljevljakovic

Sonja Svatos

Alfred Weber

Richard J Johnson

Sindhu Ramachandran

Shawn F Bairstow

Lena Nitsch

The present invention provides novel methods for reducing the serine protease and/or serine protease zymogen content of a plasma-derived protein composition. Also provided are methods for manufacturing plasma-derived protein compositions having reduced serine protease and\or serine protease zymogen content. Among yet other aspects, the present invention provides aqueous and lyophilized compositions of plasma-derived proteins having reduced serine protease and/or serine protease zymogen content. Yet other aspects include methods for treating, managing, and/or preventing a disease comprising the administration of a plasma-derived protein composition having a reduced serine protease or serine protease zymogen content.

Removal of serine proteases by treatment with finely divided silicon dioxide

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.

Method for producing factor H from a plasma precipitation fraction

The present invention provides compositions and pharmaceutical formulations of Factor H derived from plasma. Also provided are methods for the manufacture of the Factor H compositions and formulations, as well as methods for the treatment of diseases associated with Factor H dysfunction.

Manufacture of factor H (FH) and FH-derivatives from plasma

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Vienna, Austria

Ruth Madlener