Preparation of high purity factor VIII concentrates.
An improved process for producing high purity Factor VIII concentrate has been developed. The improvement was based on the combination of three precipitating agents (polyethylene glycol, glycine and sodium chloride) which heretofore have been used alone in a single step or in separate and distinct steps in a multi-step process. The product was pasteurized in solution (60 degrees C, 10 hrs) to reduce possible risks of virus transmission. The purified product has significantly higher specific activity and lower fibrinogen and immunoglobulin levels when compared to other commercial concentrates.
D011232:Chemical Precipitation; D005169:Factor VIII / Q000302:isolation & purification*; D005340:Fibrinogen / Q000032:analysis; D005998:Glycine; D006801:Humans; D007074:Immunoglobulin G / Q000032:analysis; D011092:Polyethylene Glycols; D012965:Sodium Chloride; D012995:Solubility
D007074:Immunoglobulin G; D011092:Polyethylene Glycols; D012965:Sodium Chloride; D005169:Factor VIII; D005340:Fibrinogen; D005998:Glycine