News Release

一种更安全有效的制药方法

Peer-Reviewed Publication

American Association for the Advancement of Science (AAAS)

A More Safe and Efficient Means for Drug Manufacturing

image: Photograph of deprotection gas/liquid reactor during processing. This material relates to a paper that appeared in the June 16, 2017, issue of Science, published by AAAS. The paper, by K.P. Cole at Eli Lilly and Company in Indianapolis, IN, and colleagues was titled, 'Kilogram-scale prexasertib monolactate monohydrate synthesis under continuous-flow CGMP conditions.' view more 

Credit: © Eli Lilly and Company. All rights reserved. Used with Permission

科学家们研发了一种用不间断流程技术生产药类化合物的系统,他们用其制造了一种目前正在接受临床试验评估的化疗药物。大多数药类化合物是大批量生产的,但小容量不间断(SVC)制造体系有若干优点,其中包括其安全性和产量得到提高。同样地,在需要时,它们可被方便地用来就地生产药物的成分。然而,尽管有若干SVC制造系统在实验室中成功地生产出了药类化合物,但它们中很少坚持“目前的良好操作规范”。在这里,Kevin P. Cole和同事研制了一种坚持这类标准的SVC。该系统允许进行各成分的同时间混合,它配备了无需手工操作的全自动过滤器,从而消除了操作者接触有毒物品的风险。若干不同的技术被用来分离不同的成分层,并在每次使用后有效地清理了隔室。该团队通过生产水溶液形式的化疗制剂prexasertib来展示其系统的效用,prexasertib目前作为化疗制剂正在接受II期临床试验的评估。据作者报告,该系统在3天的时间内生产了24公斤的该化合物。

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