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Fig. 5 | AAPS Open

Fig. 5

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. 5

Correlation between VP-free duration and low SVP duration for mAb X DP. The 24 formulations (listed in Table 1) were stored at 5 °C and represent unique combinations of [mAb], initial [PS20], and pH. Each formulation was monitored at 12 time points over 24 weeks for VPs (by the Ph. Eur./USP method) and cumulative SVP counts (≥ 2 µm particles/mL by HIAC liquid particle counter). SVP count threshold of < 350 particles/mL was used to determine the low SVP duration (in weeks)

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