Baxalta Gmbh

Baxter International Inc.

Baxter Healthcare Sa

Takeda Pharmaceutical Company Limited

Immuno Aktiengesellschaft

Baxter Aktiengesellschaft

Wolfgang Teschner

Hans-Peter Schwarz

Azra Pljevljakovic

Harald Arno Butterweck

Sonja Svatos

Alfred Weber

Ruth Madlener

Theresa Friederike Bauer

Bernhard Koelbl

Leopold Bruckschwaiger

Thomas Gundinger

Nebojsa Nikolic

Johanna Kindermann

Lucia Gnauer

Reinhard Grausenburger

Gerhard Poelsler

Richard J Johnson

Sindhu Ramachandran

Shawn F Bairstow

Bernhard Kölbl

Lucia Hofbauer

Julia Nuernberger

Yendra Linnau

Laura Lei

Julia Nürnberger

Johann J Eibl

Patrick Gavit

Alexander Zaydenberg

Lena Nitsch

Susan Weber

Ursula Mais-Paul

Herwig Igel

Methods are provided for the manufacture of plasma-derived immunoglobulin G compositions highly enriched for anti-parvo B19 immunoglobulin G. The methods provided do not affect the manufacturing processes or capabilities for producing plasma-derived IgG therapeutics. Plasma-derived IgG compositions that are highly enriched for anti-parvo B19 immunoglobulin G are also provided. Methods for treating parvo B19 infections by administration of plasma-derived IgG compositions highly enriched for anti-parvo B19 immunoglobulin G are also provided.

Human plasma-derived IGG preparation enriched in anti-parvo B19 natural IGGS

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 invention provides, among other aspects, methods for the manufacture of plasma-derived immunoglobulin G compositions highly enriched for anti-brain disease related protein antibodies (e.g., anti-A&#x3b2;, anti-RAGE, and anti-&#x3b1;-synuclein antibodies). Advantageously, the methods provided do not affect the manufacturing processes or capabilities for producing plasma-derived IgG therapeutics. Plasma-derived IgG compositions that are highly enriched for anti-brain disease related protein antibodies (e.g., anti-A&#x3b2;, anti-RAGE, and anti-&#x3b1;-synuclein antibodies), as also provided here. Methods for the treatment of brain diseases and disorders by administration of plasma-derived IgG compositions highly enriched for anti-brain disease related protein antibodies (e.g., anti-A&#x3b2;, anti-RAGE, and anti-&#x3b1;-synuclein antibodies), are also provided.

Methods to produce a human plasma-derived IgG preparation enriched in brain disease-related natural iggs

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

Methods to produce a human plasma-derived IgG preparation enriched in brain disease-related natural IgGs

The present invention provides, among other aspects, storage stabile aqueous formulations of immunoglobulins with histidine at a mildly acidic to neutral pH. The present invention also provides methods for stabilizing immunoglobulin compositions by formulating with histidine at a mildly acidic to neutral pH. Advantageously, the methods and formulations provided herein allow stabile aqueous compositions of immunoglobulins at mildly acidic to neutral pH useful for parenteral administration.

Stabilization of immunoglobulins through aqueous formulation with histidine at weak acidic to neutral pH

Among other aspects, the present invention provides methods for the manufacture of blood protein compositions from pooled plasma. In one embodiment, the invention provides an alcohol fractionation scheme that allows for significant increases in the yield of blood proteins purified from the starting plasma sample. In a specific embodiment, a method for fractionating pooled plasma is provided, the method comprising an initial low pH, high alcohol precipitation step. The present invention also provides pharmaceutical compositions of therapeutic blood proteins.

Fraction I-IV-1 precipitation of immunoglobins from plasma

The present invention relates to purification of butyrylcholinesterase using anion exchange material, where the butyrylcholinesterase content is enriched at least 10 fold per total protein in the composition.

Purification of butyrylcholinesterase using membrane adsorption

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Vienna, Austria

Wolfgang Teschner