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

Award Information
Agency: Department of Defense
Branch: Army
Contract: DAAH01-02-C-R019
Agency Tracking Number: A992-1950
Amount: $730,000.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: N/A
Solicitation Number: N/A
Timeline
Solicitation Year: N/A
Award Year: 2002
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
350 Second Ave., Waltham, MA, 02451
DUNS: 019677178
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 V. Guilmanov
 Project Engineer
 (781) 684-4174
 vguilmanov@foster-miller.com
Business Contact
 Ross Olander
Title: Executive Vice President
Phone: (781) 684-4242
Email: sdorsey@foster-miller.com
Research Institution
N/A
Abstract
"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)"

* Information listed above is at the time of submission. *

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