Design and Characterization of a Two-Bag Blood Products Lyophilization System

"Storage blood bags become vulnerable when defrosted. The U.S. Army has reported many instances of significant loss of blood products from storage bag breakage. Freeze-dried blood products provide an alternative to cryopreservation. The lyophilization ofplatelets and red blood cells on the laboratory level has recently been demonstrated. Industrial scale preservation of the products, preferably in storage bags, has yet to be established. During the Phase I program, breathable film materials showed highwater vapor permeation rates (4,200 to 277,000 g/m2/day). These materials were made of FDA approved polymers. Freeze-drying bovine serum albumin and a test cell line showed a significant reduction in the duration of the lyophilization cycle. Therecovery of cells was 25 percent higher than in lyo-vials.The Phase II activity will result in the manufacture of prototype storage bags and the optimization of the lyophilization process. Product shelf stability will be evaluated and in vitro and clinical tests of the products will be carried out.Foster-Miller will team with a current United States producer of pharamaceutical containers including blood storage bags and with a firm with extensive expertise in the lyophilization of biological materials to facilitate commercialization of the two-bagblood products lyophilization system. (P-01597)"