METHODS FOR PROCESSING COAGULATION FACTORS

摘要

The present application relates to methods for purifying recombinant coagulation factor proteins, including for example, prothrombin (Factor II). In embodiments, the methods provide purified prothrombin that exhibit increased bioactivity and reduced levels of thrombin, thereby increasing the safety of the prothrombin. Also provided are purified recombinant coagulation factor proteins.

主权项

1. A method for purifying a recombinant coagulation factor protein, the method comprising: a) providing a mixture comprising the recombinant coagulation factor protein; b) filtering the mixture through at least a first column to produce a first column product; c) filtering the first column product through a poly(ethyleneimine) (PEI) column to produce a PEI column product; and d) recovering the purified recombinant coagulation factor protein, wherein the purified recombinant coagulation factor protein comprises less than about 0.8/10, 0.7/10, 0.6/10, 0.5/10 or 0.4/10 missing D-carboxylated glutamic acid sites.