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

A M H P van den Besselaar; C J J van Rijn; D A Taberner; L J Goodman; L Poller; K Clarke

doi:10.1055/s-0038-1657640

Thrombosis and Haemostasis, Table of Contents

Thromb Haemost 1997; 78(02): 852-854
DOI: 10.1055/s-0038-1657640

Rapid Communication

Schattauer GmbH Stuttgart

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

A M H P van den Besselaar

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

,

C J J van Rijn

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

,

D A Taberner

²The Thrombosis Reference Centre, Withington Hospital, Manchester, UK

,

L J Goodman

²The Thrombosis Reference Centre, Withington Hospital, Manchester, UK

,

L Poller

³The Department of Pathological Sciences, The University of Manchester, Manchester, UK

,

K Clarke

³The Department of Pathological Sciences, The University of Manchester, Manchester, UK

› Author Affiliations

Abstract

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Summary

Adequate heat stability of international reference preparations (IRP) for thromboplastin (tissue factor) is an essential requirement. Accelerated degradation testing was performed by three laboratories on two candidate IRP for recombinant human tissue factor.

Heat treatment of these candidates resulted in slight shortening of the PT, contrasting with heat-induced prolongation of the PT observed with a conventional human brain derived IRP.

Heat stability of these candidates was improved when compared with the stability of previous recombinant human tissue factor preparations.

The PT-ratio did not change significantly when the candidates were stored for 28 days at 44° C. It’ can therefore be concluded that both candidates are acceptable with regard to stability.

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References

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