The Versatility of Analytical Quality by Design: Empowering Advanced Methods and Citizen Science Tools

Analytical Quality by Design is a widely recognized risk-based strategy that allows the development of analytical procedures that meet established quality requirements. Its application involves the identification of the quality hazards of the procedure and the identification of an experimental space where quality can be achieved with a certain level of probability. In order to arrive at the definition of this space, experiments must be carried out that allow the obtaining of in-depth information on the system, if appropriately planned through experimental design. To facilitate the application of this investigation method, a workflow will be presented in which the different steps and the tools that can be used will be illustrated. The examples will concern both the development of advanced analytical procedures for the quality control of biopharmaceuticals and the development of simple sensors to be used in citizen science.