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APPLICATION OF QUALITY BY DESIGN (QBD) APPROACH TO THE DEVELOPMENT OF A CYTOPHEROMETRIC ANALYTICAL METHOD OF HUMAN RED BLOOD CELLS: COMPARISON WITH TRADITIONAL DEVELOPMENT METHODOLOGY

Quality by Design (QbD) is defined as a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management, according to ICH Q section guidelines definition.
Although this definition does not specifically mention analytical methods, since 2007 there have been authors who have defended the possibility of applying the principles of QbD to the development and validation of analytical methods in order to ensure their ruggedness and robustness, especially in the field of physical and physicochemical methods related to the quantitative drug analysis.
However, in our experience, the real scope of application of QbD for analytical methods can include not only the quantitative analysis of drugs, but also other analytical methods in which other properties are determined, such as cytoferometry, a specific type of cell and particle suspension electrophoresis, with which it is possible to determine the electrophoretic mobility of normal and pathological erythrocytes.
Data of the original development of a cytopherometric method carried out in 1988 have been reprocessed according to current QbD principles, and the results obtained with the traditional methodology and with the QbD methodology have been compared.
This comparison demonstrates that the results processed following QbD show an enhancement in the knowledge and control of the cytopherometric method, giving more flexibility on physical and physico-chemical parameters management and appropriate tools to control the principal sources of analytical variability.