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A Small-Scale Process for Predicting Donnan and Volume Exclusion Effects During UF/DF Process Development

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Achieving the desired final protein formulation using Ultrafiltration/Diafiltration (UF/DF) operations is an essential component of many protein purification processes. It is well documented that differences in the excipient and buffer concentrations exist between the diafiltration and retentate solutions when they have achieved equilibrium. Several publications have proposed ways to calculate these differences. However, the accuracy of these methods has been limited by the use of an estimated protein charge value.
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http://jpharmsci.org/article/S0022-3549(18)30010-8/fulltext?rss=yes

Achieving the desired final protein formulation using Ultrafiltration/Diafiltration (UF/DF) operations is an essential component of many protein purification processes. It is well documented that differences in the excipient and buffer concentrations exist between the diafiltration and retentate solutions when they have achieved equilibrium. Several publications have proposed ways to calculate these differences. However, the accuracy of these methods has been limited by the use of an estimated protein charge value.

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