FMEA analysis on a "pilot process" to validate aptamers as therapeutic purposes

Quality principles and methodologies can strongly support the management of scientific research, in both basic and applied research laboratories, where procedures and results are rapidly changing and can hardly be standardized. In this view, Quality methodologies, such as Failure Mode and Effect Analysis - FMEA, was borrowed from the industrial field, where it is widely used in risk control and process optimization procedures, to validate and support research activities and results, to create a standard and controlled workplace, and to support the interaction between research and industrial application.We applied FMEA analysis on a "pilot" process, developed for the selection of cell-specific aptamers, in agreement with the needs of companies interested in the development of this methodology.