A process to subject pooled human plasma to a viral inactivation treatment by heating in the liquid state for 10 hrs at 60°C (pasteurization) has been designed and evaluated. Activity recovered from clotting factors and protease inhibitors exceeded 80%. Overall clotting activity remained good. No activation of coagulation factors was detected. The process did not generate aggregates. No side effects (toxicity. hypotension, variation in heart rate, thrombogenicity) could be detected in animal models. Virus kill studies, using 7 lipid-enveloped and non-enveloped viruses including HIV-1 and Sindbis virus, revealed inactivation levels similar to those obtained for plasma derivatives. Thus, pasteurisation of human plasma can be achieved in conditions that allow good recovery of biological properties while ensuring a high degree of inactivation of lipid-enveloped and non-enveloped viruses.
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