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

Storage blood bags become vulnerable when they are defrosted. In particular, the U.S. Army has reported many instances of significant loss of blood products from storage bag breakage. Freeze drying of blood products may be considered to be an alternativeto the current practice of cryopreservation. In general this technique is well established and is widely used for the preservation and long term storage of protein drugs and microbial cells. The lyophilization of platelets and red blood cells hasrecently been demonstrated. This proposal addresses the problem of lyophilizatoin of the blood products in a collection and storage bag.The general design and experimental strategy for the program involves the design of a two-bag, blood productslyophilization system, the selection and characterization of the inner and outer bag materials, and lyophilization of the test product. In particular, the water vapor transmission rates of commercially available polymer membrane materials will beexperimentally determined. The optimization conditions for lyophilization of bovine serum albumin and various blood products will be determined. A Phase I Option task will extend the test program to include modification to the polymers to obtain optimumwater vapor permeation and to carry out extensive blood product testing. (P-00886)This system provides the desired simplicity of collection, preservation, storage, reconstitution and dispensation of the blood product in one device.The primary use of thetechnology will be for improving the availability of blood products in the field under emergency situations for the Department of Defense. Commercial applications would include use in rural and disaster care situation where freezer facilities are notavailable.