Takeda Pharmaceutical Company Limited

Baxalta Gmbh

Bazalta Gmbh

Dominik Mittergradnegger

Meinhard Hasslacher

Christian Fiedler

Barbara Kraus

Horst Schafhauser

Eva Fritscher

Tanvir Tabish

Stefan Reuberger

Marian Bendik

Artur Mitterer

Leopold Grillberger

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

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

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Vienna, Austria

Dominik Mittergradnegger