Microflow Imaging Analyses Reflect Mechanisms of Aggregate Formation: Comparing Protein Particle Data Sets Using the Kullback-Leibler Divergence.

Maddux, Nathaniel R; Daniels, Austin L; Randolph, Theodore W

Maddux, Nathaniel R; Daniels, Austin L; Randolph, Theodore W.

Maddux NR; Center for Pharmaceutical Biotechnology, Department of Chemical and Biological Engineering, University of Colorado, Boulder, Colorado 80309-0596.
Daniels AL; Center for Pharmaceutical Biotechnology, Department of Chemical and Biological Engineering, University of Colorado, Boulder, Colorado 80309-0596.
Randolph TW; Center for Pharmaceutical Biotechnology, Department of Chemical and Biological Engineering, University of Colorado, Boulder, Colorado 80309-0596. Electronic address: theodore.randolph@colorado.edu.

J Pharm Sci ; 106(5): 1239-1248, 2017 05.

Article en En | MEDLINE | ID: mdl-28159641

Asunto(s)

Anticuerpos Monoclonales/química; Química Farmacéutica/métodos; Bases de Datos Factuales; Tamaño de la Partícula; Agregado de Proteínas; Anticuerpos Monoclonales/metabolismo; Técnicas Analíticas Microfluídicas/métodos

Palabras clave

accelerated stability; image analysis; immunogenicity; microflow imaging; protein aggregation; protein formulation; quality control; regulatory science; subvisible particles

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Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Tamaño de la Partícula / Química Farmacéutica / Bases de Datos Factuales / Agregado de Proteínas / Anticuerpos Monoclonales Idioma: En Año: 2017 Tipo del documento: Article

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