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
International Conference on Proteomics Bioinformatics
Characterization of Protein Therapeutics by Mass Spectrometry Recent Developments and Future Trends
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American Chemical Society National Spring Meeting Exposition
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Method Development Conference Speakers
Recommended Sessions
- Advances in HPLC Instrumentation
- Advances in Various Chromatographic Techniques
- Applications of HPLC
- Biochemical Applications
- Chemometric optimization
- Chip Based Separations
- Fundamentals and Advances in Liquid Chromatographic Separation Techniques
- High Efficiency and High Resolution Techniques
- HPLC fingerprinting in Bioinformatics and Computational Biology
- Hyphenated HPLC methods
- Method Development