Program Manager: Jon Mogford, Ph.D.
 Current efforts to improve the speed, efficiency, yield, flexibility, and expense of current-generation vaccines and monoclonal antibodies are impeded by reliance upon outdated, inefficient, and expensive processing methods that are both slow and vulnerable to disruption. Furthermore, recent problems with egg-based vaccine manufacture—such as unexpected contamination, unprecedented shortages of special pathogen-free eggs, and inability to grow certain dangerous viruses in eggs—have demonstrated vulnerabilities in current manufacturing methods.
Additionally, the identity of many new biological threat agents are unlikely to be known in advance and therefore pre-emptive manufacturing and stockpiling of countermeasures cannot always be performed. Our military's operational readiness and need for specific vaccines and monoclonal therapies require a radical solution to replace the current slow scale-up and manufacture of these lifesaving drugs.
The Accelerated Manufacture of Pharmaceuticals (AMP) program seeks to produce bulk doses of vaccine quality recombinant protein and monoclonal therapies "on demand," and in large quantities against established and new biological threats. The goal of the program is to create an extremely rapid, flexible, and cost-effective production system capable of producing 3 million bulk doses of protein for any vaccine or monoclonal antibody therapy (mAB) within 12 weeks of notification.
To achieve the program goal of 3 million bulk doses in 12 weeks, the AMP program is divided into phases of escalating capability. Each phase has milestones that require logarithmic improvements (10X between each phase) in production speed with demonstrations of cost reduction and adherence to strict biochemistry metrics.
Additionally, to demonstrate flexibility, each performer will express DARPA-specified protein or monoclonal antibody. To demonstrate the AMP platform scalability, there will be a Live Fire Test to produce 1,000 bulk doses at lab-scale against an unknown agent in 12 weeks.
The final AMP challenge is to develop 1 million bulk doses of a DARPA-specified recombinant protein suitable for formulation of subunit vaccines that will be used in DARPA-sponsored pre-clinical toxicity, efficacy, extensive animal toxicity, and immunogenicity studies. To ensure the relevance of these studies, a product development team composed of senior professionals from the vaccine pharmaceutical industry will guide the development of this effort.
The milestones and goals of AMP's manufacturing platform are aggressive and, if met, will revolutionize the production of protein-based medical countermeasures.
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