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In vitro stability studies of a Factor IX concentrate (Bebulin).
Folia Haematologica (Leipzig, Germany : 1928)
|January 1, 1983
Summary
Lyophilized Factor IX: C concentrates showed minimal activity decay when stored at room temperature or refrigerated. Even after 4-5 months past expiration, the clotting factor retained significant activity.
Area of Science:
- Hematology
- Biochemistry
- Pharmaceutical Science
Background:
- Factor IX: C is crucial for hemostasis.
- Lyophilized concentrates are used for treating Factor IX deficiencies.
- Stability of these concentrates under various storage conditions is vital for therapeutic efficacy.
Purpose of the Study:
- To evaluate the stability and activity decay of Factor IX: C in lyophilized concentrates.
- To compare the decay rates under different storage conditions: room temperature, -20°C, and +4°C.
Main Methods:
- Lyophilized Factor IX: C concentrates (Bebulin, IMMUNO) were stored under specified conditions.
- Activity levels of Factor IX: C were measured over time.
- Comparisons were made between room temperature, -20°C, and +4°C storage.
Main Results:
- A very slight and practically identical decay of Factor IX: C activity was observed across all tested storage conditions.
- Even 4-5 months past the product's expiration date, concentrates retained 70-85% of their initial Factor IX: C levels.
Conclusions:
- Lyophilized Factor IX: C concentrates exhibit excellent stability when stored at room temperature, -20°C, or +4°C.
- The product maintains significant therapeutic activity even beyond its expiration date under these conditions.