Abstract
In this study, the continuous Single-Pass Tangential Flow Filtration (SPTFF) concept is adapted for high protein concentrations. The work is based on the previously validated physico-chemical model for low concentrations and high viscosities. The model contains the Stagnant Film Model for concentration polarization, as well as the Boundary Layer Model for the mass transfer through the membrane. The pressure drop is calculated as a function of the Reynolds number. By performing preliminary experiments with a single ultrafiltration (UF) cassette, the model parameter are determined. The presented model is validated for a multi-step Single-Pass Tangential Flow Filtration. With subsequent simulation studies, an optimized process is found and confirmed by experiments. The outcome of this work shows the potential to optimize this multi-parameter dependent unit operation. This is reached by a model-based optimization allowing significant reduction of experimental efforts and applying the Quality by Design approach consistently. Furthermore, a comparison between the experimental setup and a commercial module is examined.
Highlights
Membrane-based unit operations are chosen in several positions of the downstream processing (DSP)
They are placed in front of the most purification steps to enhance their performance and lower production costs and on the other hand they are used in the end of the process for the formulation of the target protein [6]
For clean water resistance tests (CWRT), purified water was acquired with the Sartorius arium® 157 pro (Sartorius®, Gottingen, Germany)
Summary
Membrane-based unit operations are chosen in several positions of the downstream processing (DSP). Because practical experiments would exceed a rational amount, model assisted process design is a promising approach. A at risk assessment correlations must cover all possible parameters and ensure a stable process point. A risk assessment is step, required, is required, whichattributes can be visualized withprofiles aid of Ishikawa diagrams failure-mode-effect-analysis the critical quality and product have to be defined.and. Even thoughwith this isaid notofpart of the diagrams model itself, is part of the QbD approach.
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