The biodefense industry has reached a critical point in its evolution. To accelerate product development for biodefense-related diagnostics, therapeutics, and reagents, we urgently need biological consensus standards - which generally do not exist. These standards can have an impact on overall R&D productivity and quality as profound as any technological advance, a fact readily acknowledged by biodefense leaders.
Within biodefense-related R&D, standard biological materials and processes are critical in three general areas. First, standards help properly validate instruments and assays used in measuring, producing, or testing products for biodefense applications. For example, scientists need standard microorganisms to validate an instrument designed to identify threat agents from environmental samples in the field. Second, we need standard biodefense-related materials and protocols to train personnel and confirm the capabilities of a biodefense laboratory; standards are invaluable for evaluating an individual's or laboratory's performance at identifying or assaying particular bioagents. Third, standards help compare ...
