Cross-Pharma Collaboration on the Development and Evaluation of a New Mid-Scale Preparative Supercritical Fluid Chromatography Instrument

Mirlinda Biba, Mengling Wong, Anne Akin, Eric T. Manning, Lisa Schaffter, Larry Miller, Yingru Zhang, William Farrell, Jimmy O. Dasilva, Lisa Nogle, Benjamin Hritzko, Frank Riley, Robert P. Depianta, Kevin Barry, Donghong A. Gao, Eric Seest, Meenakshi Goel, Loanne Chung, James Paulson, Heewon LeeDouglas B. Moore, Shuping Dong, William Leister, Nobumitsu Fukushima, Andy Sasaki, Timothy Lee, Takayuki Iriki, Masayuki Nishimura, Masami Tomita, Michiaki Owa, Katsuhiro Tanaka, Tomohiro Shagawa, Thomas J. Moran, Takeshi Bamba, Christopher J. Welch

Research output: Contribution to journalArticlepeer-review

1 Citation (Scopus)

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. 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.

Original languageEnglish
Pages (from-to)1271-1280
Number of pages10
JournalOrganic Process Research and Development
Volume24
Issue number7
DOIs
Publication statusPublished - Jul 17 2020

All Science Journal Classification (ASJC) codes

  • Physical and Theoretical Chemistry
  • Organic Chemistry

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