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Effect of surfactants on agitation-induced submicron and subvisible particles of therapeutic proteins
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DOI：10.1016/j.xphs.2026.104366.png)
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Abstract
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• We assessed the effect of non-ionic surfactants on agitation-induced submicron particle formation by 3D-HLD and subvisible particle formation by flow imaging analysis. • The threshold surfactant concentrations for suppressing particle formation were higher for submicron particles than subvisible particles under the present agitation stress conditions. • CMC of surfactant did not explain the surfactant concentration threshold for suppressing submicron/subvisible particle formation under this stress model. • Incorporating 3D-HLD-based submicron particle analysis provided additional information not captured by subvisible particle analysis using flow imaging analysis alone.
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