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Correlation between protein-polydimethylsiloxane visible particle formation and computationally derived antibody surface properties
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DOI：10.1016/j.xphs.2026.104364.png)
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Abstract
En 中文
• Computational quantification of surface charge and hydrophobic patches on full‑length monoclonal antibodies could predict protein‑polydimethylsiloxane visible particle (psVP) formation risk. • In pre-filled syringe (PFS) formulations, charge patches contribute more to psVP formation than hydrophobic patches. • The total area of charge patches and the combined area of the top five hydrophobic patches are key predictors of psVP formation. • An accelerated assessment system using reduced poloxamer 188 (PX188) concentration enables rapid, comparative evaluation of psVP formation risk. • A quantitative relationship between headspace air volume and psVP formation risk was established in PFS.
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3.8
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