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.
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.
