Cross-Pharma Collaboration on the Development and Evaluation of a New Mid-Scale Preparative Supercritical Fluid Chromatography Instrument
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 th...
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| Veröffentlicht in: | Organic process research & development 2020-07, Vol.24 (7), p.1271-1280 |
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| creator | Biba, Mirlinda Wong, Mengling Akin, Anne Manning, Eric T Schaffter, Lisa Miller, Larry Zhang, Yingru Farrell, William DaSilva, Jimmy O Nogle, Lisa Hritzko, Benjamin Riley, Frank DePianta, Robert P Barry, Kevin Gao, Donghong A Seest, Eric Goel, Meenakshi Chung, Loanne Paulson, James Lee, Heewon Moore, Douglas B Dong, Shuping Leister, William Fukushima, Nobumitsu Sasaki, Andy Lee, Timothy Iriki, Takayuki Nishimura, Masayuki Tomita, Masami Owa, Michiaki Tanaka, Katsuhiro Shagawa, Tomohiro Moran, Thomas J Bamba, Takeshi Welch, Christopher J |
| description | 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. |
| doi_str_mv | 10.1021/acs.oprd.0c00136 |
| format | Article |
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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. 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Process Res. Dev</addtitle><date>2020-07-17</date><risdate>2020</risdate><volume>24</volume><issue>7</issue><spage>1271</spage><epage>1280</epage><pages>1271-1280</pages><issn>1083-6160</issn><eissn>1520-586X</eissn><abstract>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. 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| title | Cross-Pharma Collaboration on the Development and Evaluation of a New Mid-Scale Preparative Supercritical Fluid Chromatography Instrument |
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