TFF cassettes are widely used for final formulation of biological drug substance. For early phase molecules, process development activities are limited due to availability of purified material. This study undertakes comprehensive evaluation of several commercially available TFF cassettes with varying membrane chemistries and MWCO as well as cassette design using r-protein and mAbs. The performances of these cassettes were compared in terms of throughput, membrane fouling propensity, mass transfer and protein aggregation due to shear stress. The benefit of this study in establishing UFDF platform strategy will be discussed using a case study.<br/>

Comparative Evaluation of TFF cassettes towards establishing a platform strategy for UFDF step

2019 Spring National Meeting

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