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DOI | 10.1126/science.aan0745 |
Kilogram-scale prexasertib monolactate monohydrate synthesis under continuous-flow CGMP conditions | |
Cole, Kevin P.1; Groh, Jennifer McClary1; Johnson, Martin D.1; Burcham, Christopher L.1; Campbell, Bradley M.1; Diseroad, William D.2; Heller, Michael R.1; Howell, John R.1; Kallman, Neil J.1; Koenig, Thomas M.3; May, Scott A.1; Miller, Richard D.1; Mitchell, David1; Myers, David P.1; Myers, Steven S.1; Phillips, Joseph L.1; Polster, Christopher S.1; White, Timothy D.1; Cashman, Jim4; Hurley, Declan5; Moylan, Robert5; Sheehan, Paul5; Spencer, Richard D.6; Desmond, Kenneth7; Desmond, Paul7; Gowran, Olivia7 | |
2017-06-16 | |
发表期刊 | SCIENCE |
ISSN | 0036-8075 |
EISSN | 1095-9203 |
出版年 | 2017 |
卷号 | 356期号:6343页码:1144-1150 |
文章类型 | Article |
语种 | 英语 |
国家 | USA; Ireland |
英文摘要 | Advances in drug potency and tailored therapeutics are promoting pharmaceutical manufacturing to transition from a traditional batch paradigm to more flexible continuous processing. Here we report the development of a multistep continuous-flow CGMP (current good manufacturing practices) process that produced 24 kilograms of prexasertib monolactate monohydrate suitable for use in human clinical trials. Eight continuous unit operations were conducted to produce the target at roughly 3 kilograms per day using small continuous reactors, extractors, evaporators, crystallizers, and filters in laboratory fume hoods. Success was enabled by advances in chemistry, engineering, analytical science, process modeling, and equipment design. Substantial technical and business drivers were identified, which merited the continuous process. The continuous process afforded improved performance and safety relative to batch processes and also improved containment of a highly potent compound. |
领域 | 地球科学 ; 气候变化 ; 资源环境 |
收录类别 | SCI-E |
WOS记录号 | WOS:000403327400030 |
WOS关键词 | PHARMACEUTICALS ; PURIFICATION |
WOS类目 | Multidisciplinary Sciences |
WOS研究方向 | Science & Technology - Other Topics |
URL | 查看原文 |
引用统计 | |
文献类型 | 期刊论文 |
条目标识符 | http://119.78.100.173/C666/handle/2XK7JSWQ/196270 |
专题 | 地球科学 资源环境科学 气候变化 |
作者单位 | 1.Eli Lilly & Co, Lilly Res Labs, Small Mol Design & Dev, Indianapolis, IN 46285 USA; 2.Eli Lilly & Co, Tech Serv Mfg Sci, Indianapolis, IN 46285 USA; 3.Eli Lilly & Co, Tech Serv Mfg Sci, Greenfield, IN 46140 USA; 4.Eli Lilly & Co, Qual Assurance, Kinsale, Cork, Ireland; 5.Eli Lilly & Co, Tech Serv Mfg Sci, Kinsale, Cork, Ireland; 6.Eli Lilly & Co, Proc Engn, Kinsale, Cork, Ireland; 7.Eli Lilly & Co, Qual Control, Kinsale, Cork, Ireland |
推荐引用方式 GB/T 7714 | Cole, Kevin P.,Groh, Jennifer McClary,Johnson, Martin D.,et al. Kilogram-scale prexasertib monolactate monohydrate synthesis under continuous-flow CGMP conditions[J]. SCIENCE,2017,356(6343):1144-1150. |
APA | Cole, Kevin P..,Groh, Jennifer McClary.,Johnson, Martin D..,Burcham, Christopher L..,Campbell, Bradley M..,...&Gowran, Olivia.(2017).Kilogram-scale prexasertib monolactate monohydrate synthesis under continuous-flow CGMP conditions.SCIENCE,356(6343),1144-1150. |
MLA | Cole, Kevin P.,et al."Kilogram-scale prexasertib monolactate monohydrate synthesis under continuous-flow CGMP conditions".SCIENCE 356.6343(2017):1144-1150. |
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