Shipping-Induced Aggregation in Therapeutic Antibodies: Utilization of a Scale-Down Model to Assess Degradation in Monoclonal Antibodies.

It is vital to understand the impact of transportation on monoclonal antibody (mAb) product quality during drug product development. Fully representative real-time shipment studies are resource intensive, so in this work, we studied laboratory agitation methods to mimic the effect of real-time shipment on aggregation, specifically subvisible particle formation. The agitation methods studied include a rotator, orbital shaker, vortexer, and shipping simulator vibration table. The simulator is able to predict the particle formation behavior during real-time shipment for a number of mAbs in vial and prefilled syringe configurations, with a correlation of about 90%, whereas the other methods of agitation were inconsistent. This study demonstrates that using a shipping simulator vibration table provides an opportunity for consistent and predictive development studies of shipping stress with minimal resource requirements during early- or late-stage drug product development.