作者: John J. Lewin , Eugene J. Choi , Geoffrey Ling
DOI: 10.2146/AJHP150639
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摘要: Purpose Developmental pharmaceutical manufacturing systems and techniques designed to overcome the shortcomings of traditional batch processing methods are described. Summary Conventional processes do not adequately address needs military civilian patient populations healthcare providers. Recent advances within Defense Advanced Research Projects Agency (DARPA) Battlefield Medicine program suggest that miniaturized, flexible platforms for end-to-end pharmaceuticals possible. Advances in continuous-flow synthesis, chemistry, biological engineering, downstream processing, coupled with online analytics, automation, enhanced process control measures, pave way disruptive innovation improve supply chain drug base. These new technologies, along current ongoing regulatory science, have future potential (1) permit “on demand” on battlefield other austere environments, (2) enhance level preparedness chemical, biological, radiological, nuclear threats, (3) health authorities’ ability respond natural disasters catastrophic events, (4) minimize shortages drugs, (5) gaps orphan market, (6) support enable continued drive toward precision medicine, (7) access needed medications underserved areas across globe. Conclusion Modular under development by DARPA’s may one day safety, efficiency, timeliness manufacturing.