Program Manager: Dr. Michael V. Callahan
 Current vaccine and protein manufacturing systems require years to produce meaningful quantities of therapeutics. Consequently, these systems fail to provide timely, flexible, and cost-effective therapies to protect against a mass-casualty infection or poisoning. In addition, the identity of many new biological threat agents are unlikely to be known in advance and therefore pre-emptive manufacturing and stockpiling of countermeasures can not 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 life saving drugs.
The Accelerated Manufacture of Pharmaceuticals (AMP) Program seeks to produce therapeutics or vaccines “on demand,” in large quantity, at low cost, to interdict both established and new biological threats. AMP will significantly shorten the time required to produce high-quality protein therapeutics such as vaccines and antidotes. The goal of the program is to create an extremely rapid, flexible, and cost-effective manufacturing system capable of producing 3 million doses of GMP-quality vaccines or monoclonal antibodies (mAB) within 12 weeks.
AMP Program researchers utilize revolutionary manufacturing platforms with extraordinary flexibility, allowing for surge-capable manufacture of vaccines or medical countermeasures to protect against all known and recently emerging viral, protozoan, fungal, bacterial, and toxin threat agents. They have employed biological platforms from fungal systems with continuous perfusion fermentation to marine and plant systems with enhanced viral vectors to create more protein therapeutics.
To achieve the program goal of 3 million doses in 12 weeks, the AMP Program is divided into three phases of escalating capability. Each phase has milestones that require logarithmic improvements (10X between each phase) in efficiency, production speed, and cost effectiveness. The initial metric for Phase I is to achieve > 1 dose/L*wk for a subunit vaccine and
> 0.025 dose/L*wk for a monoclonal antibody. The final cost metric required is < $1/dose for the subunit vaccine and <$10/dose for the monoclonal antibody.
The milestones and goals of this program are aggressive and require expertise in molecular biology, protein synthesis, accelerated protein manufacture, cost modeling and certified Good Manufacturing Practices (cGMP) regulations. Each phase requires logarithmic increases in the number of doses of vaccine and/or monoclonal antibody produced in the candidate system. The AMP Program is focused on developing new technologies that will revolutionize the manufacture of protein-based therapeutics.
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