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Stabilization of spray-dried monoclonal antibody formulations with polymeric excipients
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DOI：10.1016/j.xphs.2026.104360.png)
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Abstract
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• Polymeric excipients were evaluated as stabilizers in spray-dried monoclonal antibody formulations, demonstrating alternatives to conventional sugar-based stabilizers such as trehalose and mannitol. • Hydrolyzed gelatin significantly improved solid-state stability of the mAb, showing a five-fold reduction in monomer loss under accelerated storage conditions (40°C, 90 days). • Excipient molecular weight influenced protein stability, with high molecular weight polyvinylpyrrolidone (PVP K90) showing better stability compared to low molecular weight PVP (K30) polymer. • Solid-state characterization techniques (ssFTIR, ssNMR, and XPS) revealed relationships between matrix homogeneity, surface composition, and protein stability. • Results highlight the potential of polymer-based stabilizers for spray-dried biologics to enable continuous manufacturing of monoclonal antibody formulations.
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