Our developability assessment expertise helps identify the physical and chemical properties of drug candidates, such as aggregation, post-translational modifications, stability, and solubility, that can negatively impact the safety, efficacy, manufacturability and ultimately the success of clinical candidates. Our approach combines in silico modeling, stress, stability and concentration tests. Our clients can enter the preclinical space with the knowledge of process parameters to mitigate liabilities that cannot be engineered out of the molecule, to help avoid costly and time-consuming formulation development efforts, and clinical failures with appropriate control strategies.
With a broad range of analytical services and capabilities, we provide our clients the tools and understanding to achieve successful biologics characterization and process development in a phase-appropriate manner. The analytics team collaborates with other teams and external partners to ensure the seamless transfer of knowledge.