Related Experiment Videos
[Comparative protein chemistry studies on Factor VIII concentrates]
Arzneimittel-Forschung
|January 1, 1984
Summary
Commercial Factor VIII concentrates for haemophilia treatment were analyzed for various properties. Most preparations met Factor VIII coagulation activity standards, though antigen levels often exceeded activity levels.
Area of Science:
- Hematology
- Biochemistry
- Virology
Background:
- Hemophilia treatment necessitates substantial quantities of Factor VIII concentrates.
- Quality control of these concentrates is crucial for patient safety and therapeutic efficacy.
Purpose of the Study:
- To evaluate the in vitro properties of nine commercial Factor VIII concentrate preparations.
- To assess Factor VIII coagulation activity, antigen levels, and potential viral contamination.
Main Methods:
- Analysis of Factor VIII coagulation activity (F VIII: C), ristocetin cofactor activity (F VIII R: CoF), and Factor VIII antigen (F VIII R: Ag).
- Quantification of fibrinogen, fibronectin, and immunoglobulins.
- Hepatitis A and B marker testing using serology.
Main Results:
- No significant deficit in Factor VIII coagulation activity (F VIII: C) was observed compared to manufacturer data.
- Factor VIII antigen (F VIII R: Ag) levels were consistently higher than F VIII: C across all preparations.
- One concentrate (HS) showed minimal fibrinogen, fibronectin, and immunoglobulin content; two preparations were largely cleared of hepatitis B virus markers.
Conclusions:
- Commercial Factor VIII concentrates generally meet coagulation activity requirements.
- Discrepancies between Factor VIII antigen and activity levels warrant further investigation.
- The safety profile regarding hepatitis B virus contamination appears acceptable for most tested batches.