Abstract: A novel method of protecting blood coagulation factor IX from proteases during purification or storage is disclosed. High concentrations of one or more water soluble organic or inorganic salts are used to stabilize factor IX, contained within blood plasma-derived solutions, or contained within solutions derived from other sources, against conversion to clinically unacceptable peptide structures such as factor IXa, and/or degraded factor IX peptides. The technique is useful in stabilizing intermediate purity factor IX preparations during purification, and in maintaining the integrity of purified factor IX during long term storage. Stable high specific activity factor IX preparations are also disclosed.
Type:
Grant
Filed:
March 13, 2000
Date of Patent:
August 28, 2001
Assignee:
Aventis Behring LLC
Inventors:
Chin C. Huang, Takashi Enkoji, Laura Ho, Richard R. Kleszynski, Richard L. Weeks, Fred Feldman