Table 1 VP observations in the longitudinal study with a full-factorial design to assess the impact of three formulation parameters. The 24 mAb X DP formulations—differing in [mAb], initial [PS20], and pH—were stored at 5°C and monitored for VPs over 24 weeks. Three glass vials per formulation were visually inspected for VPs at each of 12 time points according to the Ph. Eur./USP method

From: Formulation mitigations for particle formation induced by enzymatic hydrolysis of polysorbate 20 in protein-based drug products: insights from a full-factorial longitudinal study