Establishment and application of viral inactivation/removal technology for blood products / 军事医学

ABSTRACT

Objective To establish viral inactivation/removal techniques for blood products , and apply them to inacti-vation/removal process validation of blood products .Methods Enveloped and non-enveloped model viruses were propaga-ted.Viral inactivation/removal techniques for blood products ,including solvent/detergent (S/D) treatment, low pH incuba-tion, dry heat method, pasteurization,and nanofiltration, were established.The virus titer was evaluated using cytopathic effects ( CPE) and Spearman and Karber method .The viral inactivation/removal techniques were believed to be effective when LRV≥4.These techniques were used in viral inactivation /removal validation of blood products .Results Enveloped model viruses were inactivated through S/D treatment and the low pH incubation method .Enveloped and non-enveloped model viruses were inactivated through dry heat and pasteurization .Within a certain range of filtration capacity , PPV was removed through nanofiltration .Conclusion The established viral inactivation/removal techniques can be used in viral inactivation/removal process validation of blood products , which can improve viral safety of blood products .