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Fig. 12 | AAPS Open

Fig. 12

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. 12

Comparison of calculated FFA solubility limits (blue hollow circles) with corresponding FFA measurements (red filled circles), SVP counts (black filled diamonds), and VP observations (green asterisks) in mAb X DP stored at 5 °C. FFA solubility limits at the different time points for each formulation were calculated using the updated FFA solubility model by Doshi et al. (Doshi et al. 2020). Formulations were analyzed for LA, MA, and PA (by LC–MS), cumulative SVPs (≥ 2 µm particles/mL by HIAC), and VPs (by the Ph. Eur./USP method). Green asterisks (bottom panel) denote the earliest time points at which VPs were observed for the given formulation (Table 1)

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