Method of the invention preparations of factor IXa
View Patent ↗The invention provides a method of treating bleeding disorders in a subject by administration of a preparation enriched for Factor IXa. The Factor IXa can be produced by proteolytically activating recombinantly-produced Factor IX. The invention also provides an improved method for producing Factor IXa from a plasma fraction, which method results in a Factor IXa product containing little or no prekallikrein activity, thus reducing the incidence of undesired side effects in a subject.
1. A method of making a preparation of Factor IXa, wherein the preparation contains little or no impurities having prekallikrein activator activity, said method comprising;
a) dissolving a paste of Cohn fraction IV- 1;
b) adsorbing clotting factors contained in said Cohn fraction IV-1 onto calcium phosphate;
c) eluting said clotting factors from said calcium phosphate to form a first eluate;
d) applying said first eluate to an anion exchange resin, thereby adsorbing Factor IXa to said resin and allowing impurities having prekallikrein activator activity to flow through into a discard fraction; and
e) eluting and collecting said Factor IXa from said resin.