Berinert is a human plasma-derived, purified, pasteurized, lyophilized concentrate of C1 esterase inhibitor to be reconstituted for intravenous administration. Berinert is prepared from large pools of human plasma from US donors. One standard unit of C1 esterase inhibitor concentrate is equal to the amount of C1 esterase inhibitor in 1 mL of fresh citrated human plasma, which is equivalent to 270 mg/L or 2.5 ?M/L. No international laboratory standard for quantifying C1 esterase inhibitor exists. An in-house standard is used to assure lot-to-lot consistency in product potency.

Alpha1-Proteinase Inhibitor (Human), Zemaira™, is a sterile, stable, lyophilized preparation of highly purified human alpha1-proteinase inhibitor (A1-PI), also known as alpha1-antitrypsin, derived from human plasma. Zemaira™ is manufactured from large pools of human plasma by cold ethanol fractionation according to a modified Cohn process followed by additional purification steps.

Autoplex® T*, Anti-Inhibitor Coagulant Complex, Heat Treated, is a sterile product prepared from pooled human plasma with subsequent alcohol fractionation to Cohn Fraction IV1. It contains, in concentrated form, variable amounts of activated and precursor vitamin K-dependent clotting factors. Factors of the kinin generating system are also present. The product is standardized by its ability to correct the clotting time of Factor VIII deficient plasma or Factor VIII deficient plasma which contains inhibitors to Factor VIII.

CINRYZE (c1 esterase inhibitor human freeze dried powder) (C1 esterase inhibitor [Human]) is a sterile, stable, lyophilized preparation of C1 esterase inhibitor derived from human plasma. CINRYZE (c1 esterase inhibitor human freeze dried powder) is manufactured from human plasma purified by a combination of filtration and chromatographic procedures. The specific activity of CINRYZE (c1 esterase inhibitor human freeze dried powder) is 4.0 – 9.0 units/mg protein. The purity is ? 90% human C1 esterase inhibitor. Following reconstitution with 5 mL of Sterile Water for Injection, USP, each vial contains approximately 500 units of functionally active C1 esterase inhibitor, pH 6.6 - 7.4, and an osmolality between 200 – 400 mosmol/kg. One unit (U) of CINRYZE (c1 esterase inhibitor human freeze dried powder) corresponds to the mean quantity of C1 esterase inhibitor present in 1 ml of normal fresh plasma.

FEIBA VH Anti-Inhibitor Coagulant Complex, Vapor Heated (AICC) is a freeze-dried sterile human plasma fraction with Factor VIII inhibitor bypassing activity. In vitro, FEIBA VH (AICC) shortens the activated partial thromboplastin time (APTT) of plasma containing Factor VIII inhibitor. Factor VIII inhibitor bypassing activity is expressed in arbitrary units. One IMMUNO Unit of activity is defined as that amount of FEIBA VH (AICC) that shortens the APTT of a high titer Factor VIII inhibitor reference plasma to 50% of the blank value. The product is intended for intravenous administration.