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.

Method development plays a crucial role in qualitative and quantitative analysis of compounds. It various from one compound to the other significantly. Method development is now more quality oriented and uses Quality by Design (QbD) methodology to obtain accurate results. This design is particularly helpful for separation of natural and biological components.

  • Quality by design
  • Experimental design
  • Automation

Related Conference of Method Development

November 09-11, 2017

4th European Biopharma Congress

Vienna, Austria
August 20-22, 2018

9th Asian Biologics and Biosimilars Congress

Tokyo, Japan

Method Development Conference Speakers

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