Csl Limited

Csl Behring Lengnau Ag

Carsten Horn

Hubert Metzner

Stefan Schulte

Sabine Zollner

Thomas Nowak

Tobias Brandt

The present disclosure relates to a method for increasing the stability of a Factor VIII molecule after purification, lyophilization and reconstitution, comprising preventing proteolytic cleavage of the Factor VIII molecule into a first fragment comprising essentially the A1 domain and the A2 domain and a second fragment comprising essentially the A3 domain, the C1 domain and the C2 domain throughout manufacturing the Factor VIII molecule. The disclosure further pertains to a method for improving the bioavailability of Factor VIII after intravenous and non-intravenous injection.

Method for improving the stability of purified Factor VIII after reconstitution

A process for purifying a recombinant protein comprising the steps of: i) providing a solution comprising the recombinant protein; ii) adding an alkyl glycoside to the solution; and iii) purifying the recombinant protein. The addition of the alkyl glycoside provides improved clearance of process-related impurities. The purified recombinant protein of the invention has low levels of host cell DNA, host cell protein and viral contamination.

Protein purification and virus inactivation with alkyl glycosides

Method for improving the stability of purified factor VIII after reconstitution

The present invention relates to a method for increasing the stability of a Factor VIII molecule after purification, lyophilization and reconstitution, comprising preventing proteolytic cleavage of the Factor VIII molecule into a first fragment comprising essentially the A1 domain and the A2 domain and a second fragment comprising essentially the A3 domain, the C1 domain and the C2 domain throughout manufacturing of the Factor VIII molecule. The invention further pertains to a method for improving the bioavailability of Factor VIII after intravenous and non-intravenous injection.

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Marburg, Germany

Carsten Horn