PROPERTIES OF A NEW FIBRIN GLUE STABLE IN LIQUID-STATE

A pasteurized preparation of fibrin glue composed to two separate stab le, liquid components: highly purified human thrombin and fibrinogen c oncentrate is described. The components are mixed extemporaneously dur ing application. Thrombin was prepared using a prothrombin complex con centrate as starting material which was activated by calcification and then heated in solution during 10 hours at 60 degrees C in the presen ce of stabilizers. The isolation of thrombin was carried out using a c olumn of benzamidine-Sepharose 6B. The eluate contained thrombin with a high degree of purity (more than 95% assessed by SDS-PAGE) with a sp ecific activity > 2,500 IU/mg protein. The purified liquid thrombin pr eparation remained stable for at least 6 months. The fibrinogen concen trate was prepared from cryoprecipitate after removal of factor VIII a nd then virally inactivated by pasteurization in the presence of gluco se and sorbitol. After purification the concentrate containing a high level of fibrinogen was formulated with urea 0.5 M or arginine 5% befo re conditioning. Both components of the fibrin glue kept its biologica l properties for more than 6 months at + 4 degrees C.