Pharmacy on demand: New technologies to enable miniaturized and mobile drug manufacturing

作者: John J. Lewin , Eugene J. Choi , Geoffrey Ling

DOI: 10.2146/AJHP150639

关键词:

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.

参考文章(38)
J.F. Zawada, Cell-Free Production of Pharmaceutical Proteins Comprehensive Biotechnology (Second Edition). ,vol. 3, pp. 391- 397 ,(2011) , 10.1016/B978-0-08-088504-9.00537-7
P. Laurino, X. Y. Mak, Peter H. Seeberger, Synthesis of pharmaceutical and bio-active compounds in microreactors Chimica Oggi-chemistry Today. ,vol. 27, pp. 15- 17 ,(2009)
Randal Kaufman, Post-translational modifications required for coagulation factor secretion and function Thrombosis and Haemostasis. ,vol. 79, pp. 1068- 1079 ,(1998) , 10.1055/S-0037-1615018
Spencer D. Schaber, Dimitrios I. Gerogiorgis, Rohit Ramachandran, James M. B. Evans, Paul I. Barton, Bernhardt L. Trout, Economic Analysis of Integrated Continuous and Batch Pharmaceutical Manufacturing: A Case Study Industrial & Engineering Chemistry Research. ,vol. 50, pp. 10083- 10092 ,(2011) , 10.1021/IE2006752
Bernhard Gutmann, David Cantillo, C. Oliver Kappe, Continuous‐Flow Technology—A Tool for the Safe Manufacturing of Active Pharmaceutical Ingredients Angewandte Chemie. ,vol. 54, pp. 6688- 6728 ,(2015) , 10.1002/ANIE.201409318
Jonathan P. McMullen, Klavs F. Jensen, An Automated Microfluidic System for Online Optimization in Chemical Synthesis Organic Process Research & Development. ,vol. 14, pp. 1169- 1176 ,(2010) , 10.1021/OP100123E
James M. Cregg, Joan Lin Cereghino, Jianying Shi, David R. Higgins, Recombinant protein expression in Pichia pastoris. Molecular Biotechnology. ,vol. 16, pp. 23- 52 ,(2000) , 10.1385/MB:16:1:23
Satoshi Mikami, Tominari Kobayashi, Mamiko Masutani, Shigeyuki Yokoyama, Hiroaki Imataka, A human cell-derived in vitro coupled transcription/translation system optimized for production of recombinant proteins Protein Expression and Purification. ,vol. 62, pp. 190- 198 ,(2008) , 10.1016/J.PEP.2008.09.002
Kerry Routenberg Love, Vasiliki Panagiotou, Bo Jiang, Terrance A. Stadheim, J. Christopher Love, Integrated single-cell analysis shows Pichia pastoris secretes protein stochastically. Biotechnology and Bioengineering. ,vol. 106, pp. 319- 325 ,(2010) , 10.1002/BIT.22688
Pieter P Jacobs, Steven Geysens, Wouter Vervecken, Roland Contreras, Nico Callewaert, Engineering complex-type N-glycosylation in Pichia pastoris using GlycoSwitch technology Nature Protocols. ,vol. 4, pp. 58- 70 ,(2009) , 10.1038/NPROT.2008.213