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

已经采用了许多方法来灭活或去除来自人血浆的治疗性蛋白中的病毒。这些技术并不总是对广泛的人类和动物病毒有效，受到特定工艺缺陷的阻碍，并且经常导致它们旨在保护的生物制品的变性。其中一些方法在灭活包膜病毒(如HIV)方面有效，但没有一种方法对甲型肝炎病毒(HAV)等非包膜病毒有效。Aphios基于超临界流体技术开发了一种快速且普遍适用的包膜和非包膜病毒灭活技术。在拟议的工作中，我们计划通过利用恒定、放电或变化的电场来增强这项技术。到2000年，人类血浆和动物血清产品的全球市场估计将达到150亿至200亿美元。据估计，潜在的病毒灭活市场约占这种麦芽的5%，约为0.7美元至10亿美元。对这些治疗药物(新鲜冰冻血浆、纤维蛋白胶、免疫球蛋白)以及来自哺乳动物细胞培养的转基因蛋白和重组治疗药物的需求将增加市场规模，并增加对具有成本效益和普遍适用的病毒灭活技术的需求。

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.