Manufacture of factor H (FH) and FH-derivatives from plasma

摘要

The present invention provides compositions and pharmaceutical formulations of Factor H derived from plasma. Also provided are methods for the manufacture of the Factor H compositions and formulations, as well as methods for the treatment of diseases associated with Factor H dysfunction.

主权项

1. A method for preparing an enriched Factor H composition from plasma, the method comprising the steps of:
(a) extracting Factor H from a Fraction I precipitate and/or a Fraction II+III precipitate with an extraction buffer selected from the group consisting of: a solution comprising from about 10 mM to about 250 mM of a buffering agent, a conductivity of from about 5 mS/cm to about 100 mS/cm, and a pH from about 6.0 to about 9.0, and a solution comprising from about 2.5 mM to about 100 mM of a buffering agent, a conductivity of from about 0.5 mS/cm to about 2.0 mS/cm, and a pH from about 4.0 to about 5.5, to form a Factor H extract; and (b) precipitating an impurity from the Factor H extract to form a supernatant containing Factor H, thereby preparing an enriched Factor H composition.