Manufacturing & Analytical Characterization
Pawel Bigos, BS
Senior Scientist
Waters Corporation
Milford, Massachusetts
Analytical Quality by Design (AQbD) is a structured, science-based approach to method development that begins with predefined objectives and emphasizes risk-based decision-making. Unlike traditional one-factor-at-a-time method development strategies, AQbD leverages statistical tools such as Design of Experiments (DoE) and robustness simulators to explore variable interactions and optimize method performance. This enhanced approach improves understanding of method capabilities, supports regulatory expectations, and enables the development of robust, reliable chromatographic methods. This presentation will highlight AQbD applications in both small and large molecule method development, offering insights into how this framework improves method robustness and accelerates development timelines.