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Automated countercurrent chromatography method development and process scale-up at GlaxoSmithKline.

David Thornton1, Xiqin Yang1, Leo Hsu1

  • 1GlaxoSmithKline Pharmaceuticals, Analytical Sciences and Development, King of Prussia, PA 19406, USA.

Journal of Chromatography. A
|January 26, 2017
PubMed
Summary
This summary is machine-generated.

Automated solvent screening accelerates purification method development for countercurrent chromatography (CCC). This approach streamlines scalable purification processes, reducing development time and enhancing efficiency in chromatography.

Keywords:
CCCCounter-current chromatographyCountercurrent chromatographyMethod scale-upMethod transferSolvent system screening

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Area of Science:

  • Chromatography
  • Separation Science
  • Process Chemistry

Background:

  • Selecting optimal stationary and mobile phases is critical for effective purification.
  • High-performance liquid chromatography (HPLC) is commonly automated for rapid method development.
  • Countercurrent chromatography (CCC) offers unique advantages for purification but requires efficient method optimization.

Purpose of the Study:

  • To adapt automated method screening, typically used in HPLC, for countercurrent chromatography (CCC).
  • To develop and present a custom-configured automated system for CCC solvent screening.
  • To demonstrate the successful transfer of purification methods from analytical to preparative scales using CCC.

Main Methods:

  • Development of a custom automated system for CCC solvent screening.
  • Execution of automated solvent screening for CCC method development.
  • Validation of the automated method by transferring three purification processes from analytical to preparative scale.

Main Results:

  • Successful implementation of an automated system for CCC solvent screening.
  • Demonstration of efficient method transfer from analytical to preparative scale CCC.
  • Validation across CCC systems from two different manufacturers.

Conclusions:

  • Automated solvent screening is a viable and efficient approach for CCC method development.
  • The custom system facilitates faster and more reliable scalable purification process development.
  • This methodology enhances the utility of CCC for preparative separations.