The recent transmission of HIV by tested blood and plasma demonstrates the need for viral inactivation technology that can be safely applied to plasma. In Phase I, Clearant demonstrated the feasibility of applying a virucidal dose of irradiation to plasma for transfusion using the Clearant Process TM. On a commercial scale, this will be significantly less expensive than other technologies in development. Clearant proposes to develop methods of utilizing gamma-irradiation to inactivate viruses in single donor units of frozen plasma. The goal is to define and test parameters for irradiation of plasma on a commercial scale to inactivate at least 6xlogl0 of enveloped viruses and 4xlogl0 of non-enveloped viruses while retaining marker protein integrity. Protein recovery and activity will be measured using biochemical techniques. In vivo studies will assess acute toxicity, chronic toxicity, and efficacy of the irradiated plasma when compared to the non-irradiated control. Scale-up will involve preliminary screening of the plasma bag material and development of full-scale irradiation procedures at commercial facilities. Viral inactivation and stability studies will be performed at key milestones during process development. Blood banks will license the technology from Clearant, providing a significant commercial opportunity for all organizations while preventing the spread of viruses ? ?
