Analytical Quality by Design: from advanced Quality Control techniques to a Citizen Science perspective

Analytical Quality by Design (AQbD) is a widely recognized risk-based strategy that involves the identification of hazards and associated risks that may impact the Analytical Procedure (AP) performances throughout its life cycle. Depending on the application, the AP can be based on more or less sophisticated analytical techniques, but in order to obtain reliable analytical data, in-depth knowledge is required, which cannot always be achieved through experience alone. The presentation will illustrate the use of AQbD for the development of electrophoretic APs for the Quality Control of biopharmaceutical products with a focus on measuring Critical Quality Attribute “charge variants profile". It will also explore the development of a simple AP to be used for Citizen Science applications. Citizen Science has many advantages, ranging from the collection of large amounts of data to the education of citizens on current issues. However, if it requires the collection of analytical data, it must be based on simple techniques in order to contain cost. The AQbD-optimized fabrication of a paper-based microfluidic device allowed a robust design space to be established for diverse colorimetric applications, including on-field iron speciation and quantification of reductant activity in food products. Finally, a practical workflow for the application of AQbD will be provided, with particular attention to the use of Design of Experiments for revealing the “dark side” of the systems.