Method Development

Quality can be designed to processes through systematic implementation of an optimization strategy to establish a thorough understanding of the response of the system quality to given variables, and the use of control strategies to ensure quality. Recently the FDA has begun to advocate the QbD (Quality by Design) methodology for the pharmaceutical sector. The concept of method development includes modeling of the influence of values of variables on quality, design of experiments, and simplification of processes as information is collected. The extension of QbD philosophies is now applied to the development of manufacturing processes and analytical methods. The ability of a chromatographic method to successfully separate, identify and quantitate species is determined by a powerful factor called experimental design which gives a powerful suite of statistical methodology. Automation of a process is one of the keys for increasing the productivity of a research group. Scaling-up a compound separation performed on an analytical system to a preparative liquid chromatography system requires an optimization step on the analytical column. This step concerns the development of the gradient method for the isolation of the target compound with the best balance between its purity, data throughput, and analysis time.

  • Quality by design
  • Experimental design
  • Automation

Related Conference of Method Development

March 30-31 2016

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Method Development Conference Speakers