Cross-Pharma Collaboration on the Development and Evaluation of a New Mid-Scale Preparative Supercritical Fluid Chromatography Instrument,Organic Process Research & Development

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Cross-Pharma Collaboration on the Development and Evaluation of a New Mid-Scale Preparative Supercritical Fluid Chromatography Instrument
Organic Process Research & Development ( IF 3.1 ) Pub Date : 2020-05-22 , DOI: 10.1021/acs.oprd.0c00136
Mirlinda Biba ₁ , Mengling Wong ₂ , Anne Akin ₃ , Eric T. Manning ₄ , Lisa Schaffter ₅ , Larry Miller ₆ , Yingru Zhang ₇ , William Farrell ₈ , Jimmy O. DaSilva ₁ , Lisa Nogle ₉ , Benjamin Hritzko ₇ , Frank Riley ₃ , Robert P. DePianta ₃ , Kevin Barry ₁₀ , Donghong A. Gao ₁₁ , Eric Seest ₁₂ , Meenakshi Goel ₂ , Loanne Chung ₈ , James Paulson ₇ , Heewon Lee ₁₁ , Douglas B. Moore ₇ , Shuping Dong ₁₃ , William Leister ₁₃ , Nobumitsu Fukushima ₁₄ , Andy Sasaki ₄ , Timothy Lee ₄ , Takayuki Iriki ₄ , Masayuki Nishimura ₄ , Masami Tomita ₁₄ , Michiaki Owa ₁₄ , Katsuhiro Tanaka ₁₄ , Tomohiro Shagawa ₁₄ , Thomas J. Moran ₄ , Takeshi Bamba ₁₅ , Christopher J. Welch ₁₆

Affiliation

Merck & Co., Inc., Rahway, New Jersey 07065, United States
Genentech, Inc., South San Francisco, California 94080, United States
Pfizer Central Research, Groton, Connecticut 06340, United States
Shimadzu Scientific Instruments, Columbia, Maryland 21046, United States
Abbvie, Worcester, Massachusetts 01605, United States
Amgen Research, Cambridge, Massachusetts 02142, United States
Bristol Myers Squibb, Princeton, New Jersey 08540, United States
Pfizer, La Jolla, San Diego, California 92121, United States
Merck & Co., Inc., Boston, Massachusetts 02115, United States
Biogen, Cambridge, Massachusetts 02142, United States
Boehringer-Ingelheim, Ridgefield, Connecticut 06877, United States
Eli Lilly & Co., Indianapolis, Indiana 46285, United States
GSK, Upper Providence, Pennsylvania 19426, United States
Shimadzu Corporation, Kyoto 604-8511, Japan
Kyushu University, Fukuoka 812-8582, Japan
Indiana Consortium for Analytical Science & Engineering (ICASE), Indianapolis, Indiana 46202, United States

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.

中文翻译：

跨制药合作，开发和评估新型中规模制备型超临界流体色谱仪

随着制药公司认识到跨行业合作的经济和实际利益，在进行用于药物研发的新技术开发方面的竞争前合作正变得越来越普遍。我们在这里报告了最近成立的Enabling Technologies Consortium的第一个新技术开发项目之一，该项目创建了一种用于进行中规模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有助于定义一组关键产品属性，这些属性为一组仪器开发人员在创建新仪器原型时提供了指导，经过测试和小组反馈，有助于改善和完善最终产品功能。在项目团队制定了广泛的测试程序之后，将两个beta测试单元放置在两家ETC成员公司的实验室中，从而可以进行深入的性能测试。评估结果表明该系统符合所有要求的规格。我们在这里描述了这种新仪器的开发和测试，并提供了一些用于进行色谱纯化以支持药物发现和开发研究的实例。评估结果表明该系统符合所有要求的规格。我们在这里描述了这种新仪器的开发和测试，并提供了一些在进行色谱纯化以支持药物发现和开发研究中使用的示例。评估结果表明该系统符合所有要求的规格。我们在这里描述了这种新仪器的开发和测试，并提供了一些在进行色谱纯化以支持药物发现和开发研究中使用的示例。

更新日期：2020-07-17

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