RECOMBINANT VITAMIN K DEPENDENT PROTEINS WITH HIGH SIALIC ACID CONTENT AND METHODS OF PREPARING SAME

摘要

Methods of isolating highly sialylated recombinant vitamin K dependent proteins, particularly Factor IX, by chromatographic methods are described. The highly sialylated recombinant proteins are characterized. The improved Factor IX has at least 62% N-glycosylation with 3 or 4 sialic acid residues and improved bioavailability and pharmokinetic properties.

主权项

1. A method of isolating recombinant Factor IX for treatment of hemophilia comprising:
providing a preparation of recombinant Factor IX; and separating forms of recombinant Factor IX with 3 or more sialic acid residues per N-glycan; collecting fractions enriched in recombinant Factor IX with 3 or more sialic acid residues per N-glycan; and pooling the fractions having recombinant Factor IX, wherein the percentage of N-linked glycans with 3 or more sialic acid residues is at least 50%.