Turning diverse analytical data into actionable knowledge for enzymatically driven polysorbate degradation risk assessment and control in biotherapeutic protein formulations

Abstract

In recent years polysorbate (PS) degradation in biotherapeutic protein formulations has become one of the most challenging topics for residual host cell protein control. With such focus, various assays have been showcased to help inform on enzymatically driven PS degradation risk assessment and control. Access to multiple, orthogonal data sets can improve understanding but also increases complexity in data interpretation. To highlight how multiple assays can work together to provide an aligned enzymatically driven PS degradation risk assessment and control, three cases studies are discussed. The case studies are diverse in the driver for performing these experiments along with if they are proactively or reactively addressing PS degradation. From these three case studies it becomes apparent that assays are consistent in their use and alignment regarding enzymatically driven PS degradation risk assessment and control. In general, an assay will fall into one of three categories: risk informing, characterization, and extended characterization. With this information future work focused on enzymatically driven PS degradation risk assessment and control has a blueprint for what assays can be used and what the data informs on.