Phase behavior of antibodies and antibody-derived molecules in liquid formulations

Antibodies or antibody-derived products comprise the fastest growing market of biopharmaceuticals. Nevertheless, there are many bottlenecks towards their efficient and cost-effective manufacturing. A key stumbling block is due to the need for liquid formulations at high protein concentrations, where encountered problems include phase separation, opalescence, and high viscosities. The overall aim of this project is to develop methods for predicting the concentrated solution behaviour from measurements made on samples at low protein concentrations. This is essential for Formulation Development at the early stages after drug discovery when there is limited amount of the therapeutic available. The emphasis is on elucidating the molecular determinants of protein phase separation and developing theoretical methods for quantifying concentrated solution behaviour. The project involves an international collaboration between MedImmune, University of Manchester and the School of Chemical and Biomolecular Engineering at the University of Delaware