Inactivation of Hepatitis Viruses and HIV in Plasma and Plasma Derivatives by Treatment with -Propiolactone/UV Irradiation

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Abstract
A combined treatment of plasma or plasma derivatives by beta-propiolactone (beta-PL)/UV irradiation is in use at Biotest for the preparation of the virus-safe, stabilized serum (Biseko) and coagulation factor concentrates. The efficacy of this sterilization procedure has been demonstrated for HAV (greater than 8.2 log10), HBV (6.9 log10), NANBHV (greater than 4.5 log10) and HIV (greater than 6.0 log10). The methods used in these studies (titration in chimpanzees or cell cultures) are not applicable in routine monitoring of sterilization processes. We therefore developed a test system using four types of bacteriophages: phi X174, phi e, Kappa and f2. Using these bacteriophages in 88 single tests, sterilization efficacy was regularly monitored during the period from 1981 to 1986. The four types of bacteriophages showed, on average, an inactivation rate of 6.7 log10, independent of size or genome structure. This inactivation is in the range of the inactivation of the relevant pathogenic virus, HBV, by beta-PL/UV. It was shown that under the production conditions of Intraglobin and the other Biotest immunoglobulin preparations, beta-PL (without UV) is as virucidal as the combination of beta-PL/UV in plasma or cryo-poor plasma.

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