Cross-pharma collaboration on the development and evaluation of a new mid-scale preparative supercritical fluid chromatography instrument
Cross-pharma collaboration on the development and evaluation of a new mid-scale preparative supercritical fluid chromatography instrument
复制标题
跨制药公司合作开发和评估新型中型制备型超临界流体色谱仪
DOI：
10.1021/acs.oprd.0c00136
复制
发表时间：
2020
影响因子：
3.4
通讯作者：
et al.
中科院分区：
文献类型：
--
作者：
Biba;M.;et al.
随着制药公司认识到跨行业合作的经济和实际效益，开发用于药物研发的新支持技术的竞争前合作变得越来越受欢迎。我们在此报告最近成立的启用技术联盟的首批新技术开发项目之一，即创建一种用于进行中型制备型超临界流体色谱纯化的新仪器。来自 10 家制药公司的经验丰富的分离科学家团队的意见帮助定义了一组关键产品属性，为仪器开发团队创建新仪器原型提供指导，该团队的测试和反馈有助于改进和完善最终产品的功能。两个 Beta 测试单元被放置在两家 ETC 成员公司的实验室中，以便按照项目团队开发的广泛测试程序进行深入的性能测试。评估结果表明该系统满足所有要求的规格。我们在此描述了新仪器的开发和测试，并提供了几个使用其进行色谱纯化以支持药物发现和开发研究的示例。
Precompetitive collaborations on the development of new enabling technologies for conducting pharmaceutical research and development are becoming increasingly popular, as pharmaceutical companies recognize the economic and practical benefits of cross-industry collaborations. We report here one of the first new technology development projects from the recently formed Enabling Technologies Consortium, the creation of a new instrument for carrying out mid-scale preparative supercritical fluid chromatography purifications. Input from a team of experienced separation scientists from 10 pharmaceutical companies helped to define a set of critical product attributes that provided guidance to a team of instrument developers in the creation of a new instrument prototype, with testing and feedback from the group helping to improve and refine the final product features. Two beta test units were placed in laboratories at two ETC member companies, allowing for an in-depth performance testing, following an extensive testing procedures developed by the project team. The evaluation results showed that the system met all required specifications. We describe here the development and testing of the new instrument and provide several examples of its use in carrying out chromatographic purifications in support of pharmaceutical discovery and development research.