ACCELERATED DEGRADATION TEST OF LYOPHILIZED RECOMBINANT TISSUE FACTOR-LIPOSOME PREPARATIONS

Accelerated degradation experiments were performed to assess the heat stability of lyophilized recombinant tissue factor-liposome preparatio ns from two different manufacturers. When stored at 4 degrees C, these preparations did not show a significant change of the prothrombin tim e (PT). Two preparations (coded rTF-2 and rTF-a) showed a progressive prolongation of the PT on storage at 30 degrees C, 37 degrees C, and 4 4 degrees C. The third preparation showed an initial decrease of the P T at 37 degrees C and 44 degrees C followed by a progressive prolongat ion. Although none of the three preparations was absolutely stable at 30 degrees C, 37 degrees C and 13 degrees C, rTF-2 had the advantage t hat its PT-ratio (and hence its International Sensitivity Index) did n ot change under the conditions used in this study. The PT-ratio with a reference material for rabbit brain tissue factor (CRM-49S) stood und er similar conditions, did not change either.