SBIR Phase I: Supercritical Fluid Viral Inactivation in a Varying Potential Electrical Field

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A number of approaches have been employed for the inactivation or removal of viruses in therapeutic proteins derived from human plasma. These techniques are not always effective against a wide spectrum of human and animal viruses, are encumbered by process specific deficiencies, and often result in denaturation of the biologicals which they are designed to protect. Some of these methods are effective in inactivating enveloped viruses, such as HIV, but none are effective against non enveloped viruses such as HAV. Aphios has developed a rapid and generally applicable virus inactivation technique for both enveloped and non enveloped viruses based on supercritical fluid technology. In the proposed effort, we plan to enhance this technique by utilizing a constant, discharging or varying electrical field. The worldwide marketplace for human plasma and animal serum products is estimated to be S15 to S20 billion by the year 2000. The potential viral inactivation marketplace is estimated to be about 5% of this malt, approximately $0.7S to $1.0 billion. Combined demand for these therapeutics (fresh frozen plasma, fibrin glue, immunoglobulins) as well as transgenic proteins and recombinant therapeutics from mammalian cell culture will increase marketplace size and demand for cost efficient and generally applicable virus inactivation technology.