Moving beyond conventional analytical approaches to uncover what your antibody hides from you

• Proteins have personalities which are governed by physico-chemical properties
• These influence behaviors such as self-association and propensity to aggregate which can impact on safety, efficacy and long term stability
• Monitoring such properties can be challenging but is critical to the development of suitable formulations from commencing early process development through to manufacturing
• This case study for an engineered monoclonal antibody shows how sub-visible particle analysis, composition gradient multi-angle light scattering and dynamic light scattering reveal features which may be missed by other biophysical techniques

Francisco Gonzalez, Associate Principal Scientist Analytical and Formulation Development, FUJIFILM Diosynth