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Fig. 3 | AAPS Open

Fig. 3

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

Fig. 3

Cumulative SVP counts (≥ 2 µm particles/mL) measured in mAb X DP over storage duration (weeks at 5 °C). Three formulation parameters—[mAb], initial [PS20], and pH—were assessed for their impact on SVP accumulation as measured by HIAC liquid particle counter. The 24 formulations and their VP outcomes are detailed in Table 1. Colored asterisks in the plots denote the earliest time points at which VPs were observed for the formulation (with corresponding [mAb] represented by the same color)

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