Baxalta Gmbh

Takeda Pharmaceutical Company Limited

Baxter International Inc.

Baxter Healthcare Sa

Baxter Aktiengesellschaft

Bazalta Gmbh

Christian Fiedler

Meinhard Hasslacher

Artur Mitterer

Dominik Mittergradnegger

Christa Mayer

Johann J Eibl

Friedrich Dorner

Bernhard Fischer

Barbara Kraus

Horst Schafhauser

Eva Fritscher

Leopold Grillberger

Michael Dockal

Franziska Horling

Ernst Boehm

Ernst Böhm

Michael Graninger

Roman Necina

Stefan Reuberger

Tanvir Tabish

Marian Bendik

&Ouml;yvind L Sch&ouml;nberger

Jadranka Koehn

Thomas Gatternig

Marián BENDÍK

Emst Bohm

Adeno-associated liquid and lyophilized pharmaceutical compositions are provided herein. In exemplary aspects, the pharmaceutical compositions comprise about 5 mM to about 25 mM L-histidine, about 0 mM to about 150 mM sodium chloride, about 0.001% (w/v) to about 0.01% (w/v) polysorbate 80 (PS80), and about 1% to about 10% (w/v) sucrose, trehalose, or combination thereof to AAV. In exemplary aspects, the pharmaceutical compositions further comprise glycine or mannitol. Methods of preparing a pharmaceutical composition comprising AAV, methods of treating a bleeding disorder in a subject, and methods of storing AAV compositions are also provided.

Adeno-associated virus formulations

Provided herein are methods of producing an adeno-associated virus (AAV) product, methods of purifying adeno-associated virus, and methods of purifying full AAV capsids from a concentrated AAV fraction comprising empty AAV capsids and full AAV capsids.

Adeno-associated virus purification methods

Provided herein are methods of producing an adeno-associated virus (AAV) product and methods of purifying adeno-associated virus. AAV is loaded onto an affinity resin, wash steps are undertaken, and AAV is eluted from the affinity resin. Various buffers are disclosed for use in the wash steps and elution.

Provided herein are methods for purifying recombinant A Disintegrin-like and Metallopeptidase with Thrombospondin Type 1 Motif 13 (ADAMTS13) protein from a sample. The method comprises enriching for ADAMTS13 protein by chromatographically contacting the sample with hydroxyapatite under conditions that allow ADAMTS13 protein to appear in the eluate or supernatant from the hydroxylapatite. The methods may further comprise tandem chromatography with a mixed mode cation exchange/hydrophobic interaction resin that binds ADAMTS13 protein. Additional optional steps involve ultrafiltration/diafiltration, anion exchange chromatography, cation exchange chromatography, and viral inactivation. Also provided herein are methods for inactivating virus contaminants in protein samples, where the protein is immobilized on a support. Also provided herein are compositions of ADAMTS13 prepared according to said methods.

Methods of purifying recombinant ADAMTS13 and other proteins and compositions thereof

The present invention relates to a method for separating a mature von Willebrand Factor (mat-VWF) from von Willebrand Factor pro-peptide (VWF-PP) by incubating a composition comprising inducing dissociation of mat-VWF and VWF-PP by disruption of the non-covalently associated mat-VWF and VWF-PP, wherein said dissociation is induced by: (i) addition of at least one chelating agent, or (ii) increasing the pH to a pH of at least 7, and then collecting said mat-VWF to obtain a high purity, propeptide depleted mature VWF (mat-VWF).

Separation of VWF and VWF propeptide by chromatographic methods

The present invention relates to a two-step method for the purification of divalent cation binding proteins with high yield and high purity on anion exchange resin materials, to divalent cation binding proteins obtainable by said method, and to a kit comprising means for carrying out said method.

Protein purification by anion exchange chromatography

The present invention relates to a method for the purification of divalent cation binding proteins with high purity on an anion exchange resin material, to divalent cation binding proteins obtainable by said method, and to a kit comprising means for carrying out said method.

Purification method for divalent cation binding proteins on anion exchange resin

The present invention relates to a method for the purification of Vitamin K dependent proteins with high yield and high purity, particularly enriched in active protein, on anion exchange resin materials, to Vitamin K dependent proteins obtainable by said method, and to a kit comprising means for carrying out said method.

Purification method for vitamin K dependent proteins by anion exchange chromatography

Methods and systems for activating Factor X are disclosed.

Factor X activation

The present invention relates to a method for the purification of rFIX using anion exchange chromatography in the pseudo-affinity mode, wherein said method comprises a wash step with a wash buffer having a salt concentration of more than 200 mM. The purification according to the invention provides a method to enrich rFIX molecules which have been posttranslationally modified by sulfation and/or phosphorylation. The present invention further relates to purified rFIX compositions enriched in monosulfated and/or monophosphorylated rFIX molecules.

Method for the purification of recombinant blood coagulation factor IX enriched in sulfated and/or phosphorylated molecules

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Vienna, Austria

Christian Fiedler