Accelerated Degradation Test of Lyophilized Recombinant Tissue Factor-Liposome Preparations

A M H P van den Besselaar; E Witteveen; Schaefer-van H Mansfeld; J Meeuwisse-Braun; A Strebus

doi:10.1055/s-0038-1653786

Thrombosis and Haemostasis, Table of Contents

Thromb Haemost 1995; 73(03): 392-397
DOI: 10.1055/s-0038-1653786

Original Articles

Coagulation

Schattauer GmbH Stuttgart

Accelerated Degradation Test of Lyophilized Recombinant Tissue Factor-Liposome Preparations

A M H P van den Besselaar

¹The Haemostasis and Thrombosis Research Centre, Department of Haematology, Leiden University Hospital, Leiden, The Netherlands

,

E Witteveen

¹The Haemostasis and Thrombosis Research Centre, Department of Haematology, Leiden University Hospital, Leiden, The Netherlands

,

Schaefer-van H Mansfeld

¹The Haemostasis and Thrombosis Research Centre, Department of Haematology, Leiden University Hospital, Leiden, The Netherlands

,

J Meeuwisse-Braun

¹The Haemostasis and Thrombosis Research Centre, Department of Haematology, Leiden University Hospital, Leiden, The Netherlands

,

A Strebus

¹The Haemostasis and Thrombosis Research Centre, Department of Haematology, Leiden University Hospital, Leiden, The Netherlands

› Author Affiliations

Abstract

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Summary

Accelerated 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.

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References

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