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Factor VIII concentrate from cold sterilized human plasma.

W Stephan, A M Prince, R Kotitschke

Developments in Biological Standardization

|January 1, 1983

Summary

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A modified beta-propiolactone (beta-PL) and UV irradiation method effectively sterilizes factor VIII concentrate, preventing hepatitis B and non-A, non-B transmission in animal studies.

Area of Science:

Virology
Biochemistry
Hematology

Background:

Beta-propiolactone (beta-PL) with UV irradiation is a standard sterilization technique for factor IX and serum.
Factor VIII's sensitivity to beta-PL prevents its use with standard beta-PL/UV sterilization for hepatitis safety.

Purpose of the Study:

To develop a modified beta-PL/UV procedure for sterilizing factor VIII concentrate.
To assess the efficacy of this modified procedure in preventing hepatitis B and non-A, non-B virus transmission.

Main Methods:

A modified beta-PL/UV procedure was applied to factor VIII concentrate derived from cryoprecipitate.
Experimental animals (chimpanzees) were inoculated with treated and untreated cryoprecipitate and factor VIII concentrate.

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Main Results:

The modified beta-PL/UV procedure rendered the factor VIII concentrate non-infectious for hepatitis B and non-A, non-B viruses.
The original, non-sterilized cryoprecipitate was infectious in experimental animals.

Conclusions:

A modified beta-PL/UV sterilization method can produce hepatitis-safe factor VIII concentrate.
This method effectively inactivates both hepatitis B and non-A, non-B viruses in factor VIII preparations.