We propose to develop virally safe human plasma for fractionation and transfusion using y irradiation. No comprehensive means of virally inactivating plasma for transfusion exists, and plasma derivatives are vulnerable to viral transmission. Gamma radiation kills all viruses, however a commercially viable application that does not produce unacceptable damage to plasma has not been developed. Clearant's preliminary work with purified proteins demonstrated the effectiveness of our approach, which utilizes several techniques to minimize protein damage without affecting viral inactivation. One of these may both virally-inactivate plasma and make it stable at room temperature. This would be a new form of plasma with significant benefits to patients, particularly in rural areas and on the battlefield. Applying our y irradiation processes to whole plasma is expected to require significant development as plasma is a complex combination of diverse proteins, each of which must be protected. A virally-inactivated plasma for both fractionation and transfusion will improve the risk:benefit calculations inherent to transfusion medicine. The results will be less disease transmission and fewer concerns on behalf of patients and physicians. Room temperature stable plasma will also enhance medical care. Thus the benefits to society, and the commercial potential of this work are significant.
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