Analytical quality by design and design of experiments: a useless complication or an opportunity for separation sciences?

Objective: The presentation will deal with the application of Analytical Quality by Design (AQbD) and Design of Experiments (DoE) to analytical method development in the field of separation sciences. In order to assure the quality of analytical data, regulatory documents require the definition of the risk of failure map, leading to the identification of the so-called “Method Operable Design Region” (MODR). Methods: The flowchart of the application of AQbD with DoE will be shown in the field of capillary electrophoresis and chromatography for small drugs quality control and monoclonal antibody infliximab characterization. Results: The use of DoE is not mandatory for the AQbD approach, but its implementation can be successful for the risk assessment and for the definition of MODR. Conclusions: DoE allows risk evaluation and risk mitigation and its use should be encouraged to achieve scientific goals, to have greater confidence in the data and to obtain valuable information even from negative results.