Nanoparticulate Impurities in Pharmaceutical-Grade Sugars and their Interference with Light Scattering-Based Analysis of Protein Formulations

PURPOSE: In the present study we investigated the root-cause of an interference signal (100–200 nm) of sugar-containing solutions in dynamic light scattering (DLS) and nanoparticle tracking analysis (NTA) and its consequences for the analysis of particles in biopharmaceutical drug products. METHODS:...

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Bibliografische gegevens
Gepubliceerd in:Pharm Res
Hoofdauteurs: Weinbuch, Daniel, Cheung, Jason K., Ketelaars, Jurgen, Filipe, Vasco, Hawe, Andrea, den Engelsman, John, Jiskoot, Wim
Formaat: Artigo
Taal:Inglês
Gepubliceerd in: Springer US 2015
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Research Paper
Online toegang:https://ncbi.nlm.nih.gov/pmc/articles/PMC4452213/
https://ncbi.nlm.nih.gov/pubmed/25630820
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1007/s11095-015-1634-1
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