[Inhibitory and immunological profile of therapeutic serum protein solutions]

Biseko is prepared from pooled human plasma by specific stepwise adsorption of the coagulation factors avoiding spontaneous coagulation. Biseko is manufactured from pooled plasma from more than 1000 donors. In order to ensure its hepatitis safety, the starting plasma is cold sterilized by beta-propiolactone and UV-irradiation. The inhibitory and immunological profile of the cold sterilized Biseko was compared with another commercial serum preserve and normal serum. alpha 1-antitrypsin, alpha 2-macroglobulin and antithrombin III are present in Biseko and normal serum in their biologically active forms. A certain amount of the opsonin, fibronectin, is heparin-precipitable in normal serum and has thus retained its native character, while the fibronectin in the commercial serum preserve examined is not heparin-precipitable. Biseko contains fibronectin only in trace amounts. The IgG, IgA and IgM immunoglobulin concentrations and activities in the serum preserves are equivalent to those in normal serum. One major difference between normal serum and the cold sterilized Biseko is that metabolites from the coagulation pathways are absent in Biseko. Normal serum is not suitable for therapeutic purposes because of activated enzymes formed during coagulation. The chemical analysis of the protein pattern in Biseko resembles more fresh frozen plasma without coagulation factors than normal serum.