Evonik Roehm Gmbh

Biotest Ag

Jens Daufenbach

Norbert Windhab

William Martin

Matthias Germer

Andrea Engel

Melanie Liefke

Anne Benedikt

Annie De Groot

Jessica Müller-Albers

Tom Tice

Steffen Kistner

Juan Tome-Alcalde

Susanne Ullrich

Karina Winterling

Christopher Ungerer

The present invention relates to the field of therapeutic proteins, in particular, to recombinant coagulation factors. It provides a recombinant Factor VIII (FVIII) protein comprising specific point mutations at defined positions, which serve to reduce the immunogenicity of said FVIII protein, wherein the Factor VIII protein substantially retains its coagulant activity. It further provides nucleic acids encoding said de-immunized protein, cell lines and methods of recombinant preparation as well as pharmaceutical compositions comprising the recombinant FVIII of the invention, which are advantageous for use in treatment of patients with Hemophilia A, particularly those who have not yet been treated with a FVIII product. Additionally, it can be a safe alternative for previously treated patients and even for patients who have developed an immune-response to FVIII, e.g., for immune-tolerance-induction therapy (ITI/ITT) or rescue ITI. The invention also provides an assay for determining immunogenicity of a protein.

De-immunized factor VIII molecule and pharmaceutical compositions comprising the same

A process for preparing a powder, which includes one or more human coagulation factor proteins and a lactic acid polymer, involves mixing and dispersing a lactic acid polymer with a particle size din the range 0.1-2 &#x3bc;m and the one or more human coagulation factor proteins in water. The dispersion is dried, and the resulting dried mass is compressed. The resulting compressed dried mass is comminuted to a powder with a particle size din the range of more than 0.5 and up to 5 &#x3bc;m.

Process for preparing a powder comprising a human coagulation factor protein and a lactic acid polymer

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Mainz, Germany

Jens Daufenbach