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Heat stability of two candidate international reference preparations for recombinant human tissue factor
A M van den Besselaar1, C J van Rijn, D A Taberner
1Haemostasis and Thrombosis Research Centre, Department of Haematology, University Hospital Leiden, The Netherlands.
Thrombosis and Haemostasis
|August 1, 1997
Summary
New recombinant human tissue factor candidates demonstrate adequate heat stability for international reference preparations. Accelerated degradation testing confirmed their suitability, showing improved stability over previous versions.
Area of Science:
- Biochemistry
- Hematology
- Clinical Chemistry
Background:
- Thromboplastin (tissue factor) is crucial for hemostasis and widely used in diagnostic assays.
- International Reference Preparations (IRPs) require rigorous stability testing, including heat stability, to ensure reliable diagnostic results.
- Recombinant human tissue factor offers a standardized alternative to traditional tissue factor sources.
Purpose of the Study:
- To assess the heat stability of two candidate International Reference Preparations (IRPs) for recombinant human tissue factor.
- To compare the stability of these candidates against conventional thromboplastin and previous recombinant preparations.
- To determine the suitability of the candidates for use as IRPs based on accelerated degradation testing.
Main Methods:
- Accelerated degradation testing involving heat treatment was conducted by three independent laboratories.
- Prothrombin time (PT) and PT-ratio were measured to evaluate the impact of heat stress on thromboplastin activity.
- Candidate IRPs were stored at an elevated temperature (44°C) for 28 days to simulate long-term stability.
Main Results:
- Heat treatment of candidate recombinant human tissue factor preparations resulted in a slight shortening of the prothrombin time (PT).
- This effect contrasted with the heat-induced prolongation of PT observed with a conventional human brain-derived IRP.
- The PT-ratio remained stable for the candidate IRPs after 28 days of storage at 44°C, indicating good thermal stability.
- The heat stability of the candidate preparations was found to be superior to that of earlier recombinant tissue factor versions.
Conclusions:
- The two candidate recombinant human tissue factor preparations exhibit acceptable heat stability for use as International Reference Preparations.
- Their performance under accelerated degradation conditions suggests they can maintain reliable activity over time.
- These findings support the potential adoption of these candidates as standardized reagents in thromboplastin assays.
