Method for using light scattering in real time to directly monitor and control impurity removal in purification processes

The invention provides a method for controlling contaminants in biopharmaceutical purification processes by using light scattering and UV absorbance to establish a determinant. The invention makes use of multi-angle light scattering (MALS) and UV as a continuous monitoring system to provide informat...

Ausführliche Beschreibung

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Bibliographische Detailangaben
Hauptverfasser: Hewig, III, Arthur C, Yigzaw, Yinges, Phan, Duke H, Bailey, Robert
Format: Patent
Sprache:eng
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Beschreibung
Zusammenfassung:The invention provides a method for controlling contaminants in biopharmaceutical purification processes by using light scattering and UV absorbance to establish a determinant. The invention makes use of multi-angle light scattering (MALS) and UV as a continuous monitoring system to provide information about the elution peak fractions in real-time instead of conventional pooling methods that rely on a predetermined percent UV peak max value to initiate the pooling process; regardless of product quality.