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Fig. 7 | AAPS Open

Fig. 7

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. 7

Rate of change in [PS20] 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. Intact [PS20] remaining in each formulation at 12 time points over 24 weeks was quantified by HPLC-ELSD. The rate of change in PS20 concentration (d[PS20]/dt) was calculated as the derivative from fitting the longitudinal model

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