Baxalta Gmbh

Baxter International Inc.

Takeda Pharmaceutical Company Limited

Baxter Healthcare Sa

Christa Mayer

Meinhard Hasslacher

Artur Mitterer

Christian Fiedler

Mantas Malisauskas

Martin Feichtinger

Julia Anzengruber

Philipp M Bärnthaler

Wolfgang Mundt

Birgit Maria Reipert

Birgit Reipert

The present invention relates to a method for purifying a Factor VIII (FVIII) subspecies from a composition comprising FVIII, said method comprising an anion exchange chromatography step, a size exclusion chromatography step, and a concentration step. The invention also relates to a composition comprising a purified FVIII subspecies.

Purification of Factor VIII subspecies

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

Purification of factor VIII subspecies

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 provides methods for purifying Von Willebrand factor (VWF) for increased removal of non-lipid enveloped viruses.

Purification of VWF for increased removal of non-lipid enveloped viruses

The invention relates generally to methods of concentrating mixtures including shear sensitive biopolymers, such as von Willebrand Factor. Conventional methods of concentrating biopolymers impart too much shear stress, which causes the degradation of shear sensitive biopolymers. The methods disclosed herein reduce the shear stress while maintaining a high rate of filtrate flux. Disclosed herein is a method for concentrating shear sensitive biopolymers including flowing a mixture with a shear sensitive biopolymer into a hollow fiber dialysis module to form a retentate having a shear sensitive biopolymer concentration that is greater than that of the mixture. Hollow fiber dialysis modules have high filtrate fluxes and low shear rates at low flow rates. This ensures a high product yield and minimal loss of shear sensitive biopolymers.

Methods of concentrating shear-sensitive biopolymers

The present invention relates to a method for producing a mature von Willebrand Factor (VWF) from von Willebrand Factor pro-peptide comprising the steps:

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Wolfsthal, Austria

Christa Mayer