Evaluation of Surface Protectants on mAb Aggregation

Example 5

The purified fractions were tested for their ability to prevent surface induced aggregation through the use of an agitation study. mAb A was diluted to 0.5 mg/mL in 0.9% saline with varying amounts of each of the PS20 fractions (F1a, F2a, and F3a from 0.0001% to 0.01%, w:v) in 10 mL PETG vials. These vials were agitated on an orbital shaker at 180 RPM for 2 hours at ambient temperature. Following agitation, the samples were observed using a Bosch APK system with 10× magnification and rotation.

During the agitation study, it was observed that F2a required the lowest concentration to be protective from visible particle formation upon agitation, with F1a requiring the most. F3a and the all laurate PS20 produced similar results (FIG. 5). Although F2a had a higher CMC and comparable equilibrium surface tension impact to F3a and all laurate PS20, it was the most protective of the mAb against agitation stress and particle formation.