DEVELOPMENT OF AN IMPROVED VIRUS-FREE FIBRIN GLUE

这项I期SBIR研发计划的总体目标是利用独特有效的病毒灭活技术，开发一种改进的无病毒纤维蛋白胶密封剂，用于现成的手术应用和烧伤治疗。来源于人血浆的纤维蛋白胶产品的治疗用途受到限制，因为可获得的产品使用有效的病毒灭活步骤来制造，以确保材料的安全性。目前用于纤维蛋白胶病毒灭活的方法要么受到过程的性质的限制，其中蛋白质被破坏，蛋白质产量低，要么无法灭活包膜和非包膜病毒。在提出的努力中，我们的具体目标是利用一种独特的超临界流体病毒灭活技术来开发一种纤维蛋白胶产品，该产品在灭活包膜和非包膜病毒的同时保持生物活性。这项研究将导致一种具有成本效益的无病毒纤维蛋白胶产品的生产，允许在伤口愈合和其他生物医学适应症中进行进一步和更广泛的临床评估。建议的商业应用：无病毒纤维蛋白胶的可用性将允许这种生物材料安全地应用于主要的术中和术后手术，并加强对其在其他领域伤口愈合应用的研究，如烧伤的皮肤移植。

The overall goal of this Phase I SBIR R & D program is develop an improved virus-free fibrin glue sealant for off-the-shelf surgical applications and burn treatment by utilizing a unique and effective virus inactivation technology. The therapeutic use of a fibrin glue product derived from human plasma have been limited by the availability of a product manufactured using an effective viral inactivation step to ensure the safety of the material. Current processes for the viral inactivation of fibrin glue are limited by either the nature of the process in which proteins are damaged, the protein yield is low, or the inability to inactivated both enveloped and nonenveloped virus. In the proposed effort, our specific aim is to utilize a unique supercritical fluid viral inactivation technology for the development of a fibrin glue product which retains biological activity, while inactivating enveloped and non-enveloped viruses. This investigation should lead to the cost- effective production of a virus-free, fibrin glue product allowing further and more extensive clinical evaluation in wound healing and other biomedical indications. PROPOSED COMMERCIAL APPLICATION: The availability of a virus-free fibrin glue will allow the safe application of this biomaterial in major intra-operative and post-operative procedures, and enhance research into it wound healing application in other areas, such as the skin grafting of burns.