Design Space Development for Lyophilization Using DOE and Process Modeling

In the Quality by Design framework, there is a significant emphasis on the robust characterization of manufacturing processes and prospectively identifying manufacturing design space that ensures product quality. In this article, we discuss an approach that leverages risk assessments, design of experiments, and mechanistic modeling of unit operations to establish a design space that is relevant for manufacturing. We present an overview of our methodology and its application to lyophilization process characterization for a monoclonal antibody formulation.