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[Virus safety of labile plasma products from the German viewpoint]
1Biotest Pharma, Frankfurt, Main, BRD.
Abstract:
Unstable plasma derivatives are sterilized in Germany according to three methods. Combined treatment with beta-propiolactone + UV irradiation: in use at Biotest since 1968; Pasteurisation in sulution, 10 h at 60 degrees C in the presence of a maltose-glycin stabilizer; in use at Behring Werke since 1980; Treatment with solvent + detergent (tri-n-butyl phosphate + Tween 80 (sodium cholate]: in use at DRK Hagen and Biotest since 1987/88. The safety of unstable plasma derivatives sterilized according to these methods has been shown in studies in chimpanzees as well as in clinical studies.