From Molecule to Formulation: A Systematic Approach to Assess Biologics Developability
Abstract: This presentation introduces a systematic, data-driven approach for assessing the developability of biologic therapeutics, with a focus on pre-formulation development. The workflow is designed to facilitate early risk identification and streamline the advancement of candidates through the development pipeline. A case study featuring a monoclonal antibody illustrates the application and impact of key developability assessment techniques. These include profiling of colloidal and conformational stability, forced degradation studies, and formulation screening using design of experiments (DoE). The integration of predictive stability modeling and empirical stress testing across diverse excipient systems highlights the robustness and efficiency of the approach.