Systems For Alternate Sources Of Thrombin And Fibrinogen For Human Use

Not Available "Morphotek and Rockland will collaborate to develop mammalian cell lines that are capable of producing significant amounts of recombinant fibrinogen and thrombin from mammalian-based systems as an alternative source to plasma-derived proteins for their usein developing affordable hemostatic bandages for widespread use. Morphotek will employ its platform technology and expertise in whole cell evolution to derive lines that can over-produce these proteins as a means to lower the costs associated with theprocessing and analysis of purified protein. Rockland will employ its technology and know-how to scale the production of these lines in 15L fermentors to achieve robust production of these proteins to a level > 0.5g/L in serum-free medium. Successfulachievement of the goals of the Phase I will allow for an opportunity to develop these reagents at a reasonable cost-of-goods for use in wound care products and use in developing cost-effective hemostatic bandages for military use. The generation of robustrecombinant protein expression from a defined culture system as outlined in this application will lead to a cost-effective bioprocessing system for generating the proposed recombinant materials as products for wound care. Upon successful completion of thePhase I program, we will apply the derived reagents and technology in a Phase II proposal to demonstrate equivalent bioactivity of these molecules in in vivo wound models and in in vitro clotting assays as well as develop a streamlined process for thecost-effective production of fibrinogen and thrombin for use in hemostatic bandages. The successful completion of these goals will lead to commercialization of affordable hemostatic bandages as wound care products for civilians and military personnel."