Manufacturing process development of new drug substances in the pharmaceutical industry combines numerous chemical challenges beyond the efficient synthesis of complex molecules. Pharmaceutical chemists have to evaluate multiple options and cover a wide chemical space in a short time for optimizing productivity, greenness and cost-effectiveness of a viable manufacturing process. The time constraints of developing dedicated analytical methods prior to each analysis session can easily lead to sample analysis becoming a bottleneck in synthetic route development. In order to minimize this risk, analytical and synthetic chemists have recently pushed the boundaries of chromatographic method development and optimization to enable rapid implementation of generic or more universal methods that cover multiple compound classes in a single experimental run. Such generic methods require significant resolving power to separate a broad range of different molecules without additional method customization, but must be simple enough to allow for routine use by chemists, chemical engineers and other researchers with little experience in chromatographic method development. In addition, this approach offers the advantage of significant time saving in method development and validation. In this presentation, we will illustrate some of our recent investigations into the development and implementation of generic chromatographic methods applied to the quantitative analysis, as well as analytical and preparative separation of closely related multi-component mixtures including: residual solvents, metal scavengers, additives, isomers, and organohalogenated species, among others.

Universal chromatographic methods and fit for purpose workflows in the research and development of new pharmaceuticals

2019 Fall National Meeting

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