Accelerated Degradation Test of Lyophilized Recombinant Tissue Factor-Liposome Preparations

Abstract

SummaryAccelerated degradation experiments were performed to assess the heat stability of lyophilized recombinant tissue factor-liposome preparations from two different manufacturers. When stored at 4° C, these preparations did not show a significant change of the prothrombin time (PT). Two preparations (coded rTF-2 and rTF-a) showed a progressive prolongation of the PT on storage at 30° C, 37° C, and 44° C. The third preparation showed an initial decrease of the PT at 37° C and 44° C followed by a progressive prolongation. Although none of the three preparations was absolutely stable at 30° C, 37° C and 44° C, rTF-2 had the advantage that its PT-ratio (and hence its International Sensitivity Index) did not change under the conditions used in this study. The PT-ratio with a reference material for rabbit brain tissue factor (CRM149S) stored under similar conditions, did not change either.

Heat Stability of Two Candidate International Reference Preparations for Recombinant Human Tissue Factor

“…Only one of the previous recombinant preparations (coded TFS-002) showed an initial and temporary shortening of the PT followed by a progressive prolongation (8). With all non-recombinant tissue factor preparations a prolongation of the clotting time had been observed after heat treatment (3,8,9). In the present study, a conventional tissue-derived tluomboplastin (BCT/25 3 ) was included and the expected prolongation of the clotting times was confirmed ( Table 5).…”

“…The results of the present study can be compared with those of a similar investigation of the heat stability of earlier recombinant human and conventional rabbit tissue factor preparations (8). The behaviour of the present candidate IRP in accelerated degradation testing is different from that of the previous preparations.…”

“…This effect was observed more frequently with reagent Yl95 than with Xlgs.In contrast, almost all of the previous recombinant preparations showed a prolongation of the PT when stored at increasing temperatures. Only one of the previous recombinant preparations (coded TFS-002) showed an initial and temporary shortening of the PT followed by a progressive prolongation (8). With all non-recombinant tissue factor preparations a prolongation of the clotting time had been observed after heat treatment (3,8,9).…”

International Normalized Ratios (INR): the first 20 years

“…As there can only be limited volumes of the respective IRP, these have to be used sparingly and have been replaced at regular intervals by successor IRP [34,35,39–41]. Currently, supplies of the third rabbit IRP (RBT/90) are exhausted and a new international collaborative procedure is to be undertaken in 2004 to replace it.…”

Thromboplastin Bilbao: Reproducibility and Sensitivity of a Spanish Thromboplastin

“…An accelerated degradation test was performed [13]. We used a batch of thromboplastin and a pool of 20 fresh normal plasma samples plus another pool of stabilized anticoagulated patients.…”