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A test method for the absence of thrombogenicity in factor IX complex.
Developments in Biological Standardization
|January 1, 1979
Summary
Active clotting factors in Factor IX preparations caused consumption coagulopathy in patients. A modified TGT test with calcium ions detected these factors, necessitating updated safety testing for biological products.
Area of Science:
- Hematology
- Biotechnology
- Clinical Pathology
Background:
- Factor IX concentrates are crucial for treating hemophilia B and liver cirrhosis complications.
- Current Japanese Minimum Requirements for Biological Products test for active clotting factors before release.
- Consumption coagulopathy, a serious bleeding disorder, was observed post-administration of Factor IX preparations.
Observation:
- The TGT determination method detected active clotting factors in Factor IX preparations previously deemed safe.
- These preparations were administered to patients with liver cirrhosis and hemophilia B, leading to coagulopathy.
- The observed adverse events suggested limitations in existing safety testing protocols.
Findings:
- A modified TGT assay incorporating calcium ions successfully identified active clotting factors in the implicated Factor IX preparations.
- No correlation was found between the clotting activity detected by the modified test and the Factor IX potency.
- Heparin addition did not significantly alter the results of the modified TGT assay.
Implications:
- The findings highlight the need to revise the Japanese Minimum Requirements for Biological Products for biological products.
- Implementing the modified TGT assay with calcium ions can enhance the safety of Factor IX preparations.
- Improved safety testing can prevent adverse events like consumption coagulopathy in patients receiving blood products.