Baxalta Gmbh

Baxter International Inc.

Baxter Healthcare Sa

Takeda Pharmaceutical Company Limited

Azra Pljevljakovic

Hans-Peter Schwarz

Wolfgang Teschner

Sonja Svatos

Ruth Madlener

Alfred Weber

Harald Arno Butterweck

Bernhard Koelbl

Nebojsa Nikolic

Theresa Friederike Bauer

Leopold Bruckschwaiger

Johanna Kindermann

Thomas Gundinger

Reinhard Grausenburger

Gerhard Poelsler

Julia Nuernberger

Julia Nürnberger

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 invention relates to a new and improved method for preparing a highly concentrated immunoglobulin composition from pooled plasma for subcutaneous injection. A composition comprising 20% or more immunoglobulin suitable for subcutaneous use is also described.

Method to produce a highly concentrated immunoglobulin preparation for subcutaneous use

The present invention provides improved methods for the manufacturing of IVIG products. These methods offer various advantages such as reduced loss of IgG during purification and improved quality of final products. In other aspects, the present invention provides aqueous and pharmaceutical compositions suitable for intravenous, subcutaneous, and/or intramuscular administration. In yet other embodiments, the present invention provides methods of treating a disease or condition comprising administration of an IgG composition provided herein.

Method to produce an immunoglobulin preparation with improved yield

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

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Vienna, Austria

Azra Pljevljakovic