Manufacturing a rapid biologic response

Abstract

There are two major components in making new biologic medical countermeasures available for bio-defense and pandemic response: (1) the detection/discovery of effective countermeasures, and (2) their subsequent Process Development (PD) and manufacture. PD and manufacturing, however, are often the most costly and time-consuming parts of the process, potentially taking years and costing hundreds of millions to billions of dollars. To address these long timelines, governments have historically stockpiled countermeasures for known biothreats. Unfortunately, this kind of stockpiling is very expensive, and does not provide protection against novel threats. Fortunately, there currently exist many new technologies that, when combined strategically, have the potential to significantly reduce the time and cost associated with the PD and manufacturing of biologic countermeasures. Drug Dev Res 70:288–295, 2009. © 2009 Wiley-Liss, Inc.