Advances in Automated Multicolumn Screenings Combined with Computer-assisted Modeling for Analytical and Preparative Chromatography of New Pharmaceuticals

Friday, March 12, 2021: 10:40 AM - 11:15 AM

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Description

Manufacturing process development of new drug substances in the pharmaceutical industry combines numerous chemical challenges beyond the efficient synthesis of complex molecules. Pharmaceutical chemists must survey a wide array of synthetic variables to develop a highly productive, green, and cost-effective manufacturing process. The time constraints of developing efficient and productive chromatographic methods prior to each processing step can easily lead to sample analysis becoming a bottleneck in synthetic route development. This presentation outlines our recent efforts in overcoming these challenges through the introduction of new automated multicolumn screenings and computer-assisted modeling approaches. Herein, this strategy is applied to both analysis and purification workflows, enabling simpler 1D and 2D-LC method development for both analytical and preparative applications, including the separation, analysis and purification of multicomponent reaction mixtures of pharmaceutical intermediates and impurities. These powerful analytical methodologies are employed to minimize the time spent developing new analytical assays, while also facilitating method transfer to manufacturing facilities and application in regulatory settings.

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Additional Info

Keywords: Please select up to 4 keywords ONLY:
Biopharmaceutical,Chromatography - Other,Method Development,Prep Chromatography/Isolation/Purification