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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
1   The Haemostasis and Thrombosis Research Centre, Department of Haematology, University Hospital Leiden, The Netherlands
,
C J J van Rijn
1   The Haemostasis and Thrombosis Research Centre, Department of Haematology, University Hospital Leiden, The Netherlands
,
D A Taberner
2   The Thrombosis Reference Centre, Withington Hospital, Manchester, UK
,
L J Goodman
2   The Thrombosis Reference Centre, Withington Hospital, Manchester, UK
,
L Poller
3   The Department of Pathological Sciences, The University of Manchester, Manchester, UK
,
K Clarke
3   The Department of Pathological Sciences, The University of Manchester, Manchester, UK
› Author Affiliations
Further Information

Publication History

Received 12 1996

Accepted after revision 26 March 1997

Publication Date:
12 July 2018 (online)

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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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