Viral contamination is a constant threat in the production of plasma and derived therapeutic proteins (1,2). Currently, a variety of decontamination measures is available, including Pasteurization, solvent/detergent treatments and u/v irradiation; none provides assurance of efficacy against the range of viral pathogens that may be present (3). New methods are needed. Recent advances in N-Halamine polymer chemistry permit creation of contact biocidal surfaces, expressing rapid, potent efficacy against bacterial and viral pathogens in fluid streams (4,5,6). In this study, the feasibility of using these polymers is explored, for inactivating both enveloped and non-enveloped viruses. Functional retention of certain plasma proteins will also be determined. Plasma suspensions of enveloped and non-enveloped viruses (Vesicular stomatitis VSV and encephalomyocarditis EMCV) will be passed through columns of N- halamine polystyrene polymers, and flow rates and contact times varied to establish a) parameters necessary to bring about a 6 log inactivation, b) retention rates of coagulation factors F IX, F VIII as indicators of the practical potential of the process. Results will be used to determine the suitability of the method for extended studies on a wide range of viral targets and plasma protein functions, with additional polymers in the N-halamine series.Proposed Commercial Applications:Novel biocidal polymers with rechargeable antimicrobial activity may prove effective for inactivation of viruses in plasma, plasma protein preparations, and therapeutic proteins made through transgenic animal technology. Commercial applications of this approach by fluid stream or batch treatment with polymers could be developed for manufacturers and blood product processors. Use of such products could have a serious impact on the safety of biological agents derived from human blood and animal blood or body fluids.
Thesaurus Terms:antiseptic sterilization, biomaterial development /preparation, biomaterial evaluation, blood protein, method development, polymer, serum, virus infection mechanism Vesiculovirus, coagulation factor IX, coagulation factor VIII, encephalomyocarditis virus, protein structure /function
