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Fig. 9 | AAPS Open

Fig. 9

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. 9

Rate of change in [LA] as a function of [mAb] in mAb X DP stored at 5 °C. The 24 formulations (listed in Table 1) represent unique combinations of [mAb], initial [PS20], and pH. LA represents the most abundant degradant from PS20 hydrolysis. [LA] in each formulation was quantified by LC–MS. The rate of change in LA concentration (d[LA]/dt) was calculated as the derivative from fitting the longitudinal model

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