The Defense Biological Product Assurance Office (DBPAO) has announced intentions to award a contract extension to BBI Research Inc., of Madison, Wisc. for the manufacture of biodefense lateral flow immunoassay strips.
The assays support DoD operational needs in detecting Biological Warfare Agents (BWAs) and are used in operational biosurveillance of life-threatening biological agents for homeland security and force protection.
BBI Research Inc. has already successfully performed First Article Testing (FAT) using these government-furnished antibody materials, demonstrating that they can manufacture these assays in accordance with the DBPAO performance criteria.
The contract notes that a moratorium on production, shipment, and handling of any live or inactivated Biological Select Agents and Toxins or derivatives has been in-place since September for affiliated DoD laboratories, a consequence of the accidental live anthrax shipments associated with Dugway Proving Grounds.
Since BBI Research Inc. is a DBPAO performer, they fall under the auspices of the moratorium. Exclusions to the moratorium allowed for the shipping of LFI assays. This was further expanded to allow BBI Research Inc. to utilize government furnished inactivated materials already in inventory in order to continue to manufacture these vital LFI assays. The exclusions did not extend to the shipping of antigenic material.
“With the indefinite closure of DPG and extension of moratorium, which is anticipated to be lengthy, and no other readily available way to provide continued supply of inactivated materials to manufacture LFI strips, two 12-month options will allow for continuity of LFI supply if necessary,” states the announcement.