Degradation in Co-Formulation of Therapeutic Proteins

摘要

Delivery of multiple therapeutic proteins in combination has been proposed as a potential route to targeted and precision medicine. Proteins targeted to different sites of action would be mixed in specific ratios and then an optimal formulation required that will preserve their activity and keep degradation to a minimum. However, the measurement of degradation for such co-formulation is very challenging because the sizes of the components (e.g. multiantibody formulation) are similar, or otherwise the spectroscopic signal of the minor component is overshadowed by the major component. In this study, a mixture of monoclonal antibody and Fab fragment are used as model system to develop analytics to investigate their mechanisms of aggregation and fragmentation, particularly for the minor component, in this co-formulation.