Novo Nordisk Healthcare Ag

Janus Krarup

Daniel E Rasmussen

Egon Persson

Arne Staby

Haleh Ahmadian

Susanne Bang

Thomas Budde Hansen

Are Bogsnes

Anne Charlotte Arentsen

Lars Sejergaard

The invention relates to a method of controlling a polypeptide modification reaction, in particular but not exclusively, a method of controlling the activation of human factor VII (FVII) to produce human factor VII(a) (FVII(a)). The invention also relates to polypeptides obtainable by the polypeptide modification reaction and to pharmaceutical compositions comprising said polypeptides.

Method of controlling a polypeptide modification reaction

The present application relates to a method of reducing the content of dimers in Factor VII polypeptide composition by heat treatment.

Reduction of dimer content in factor VII polypeptide compositions by heat treatment

The present invention relates to Vitamin K-dependent protein compositions having a very low, or negligible, content of protein contaminants. The present invention also relates to method applicable in the preparation of such Vitamin K-dependent protein compositions. Such methods may either be used alone or in sequential combination with the purpose of reducing the relative content of protein contaminants. The present invention is particularly relevant in the preparation of compositions of coagulation factors selected from Factor X polypeptides (FX/FXa), Factor IX polypeptides (FIX/FIXa), Factor VII polypeptides (FVII/FVIIa), and the anticoagulant Protein C, in particular Factor VII polypeptides.

Reduction of the content of protein contaminants in compositions comprising a vitamin K-dependent protein of interest

The invention described herein provides new methods of preparing purified Factor VII polypeptide drug substances in large quantities (industrial scale levels) that are associated with reduced content of product-related impurities (e.g., late eluting peaks) and/or that exhibit a relatively uniform glycosylation pattern.

Hydrophobic interaction chromatography purification of factor VII polypeptides

The present invention relates to a process for the purification of a protease.

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Gentofte, Denmark

Janus Krarup