Abstract
In this study the Single-Pass-Tangential-Flow-Filtration (SPTFF) concept for continuous ultrafiltration in bioprocessing is investigated. Based on a previously validated physico-chemical model for a single ultrafiltration cassette, the transfer to a multistage SPTFF is predicted and validated experimentally by concentration steps for bovine serum albumin (BSA) and the monoclonal antibody immunoglobulin G (IgG) are compared. The model applied for the ultrafiltration membrane contains the Stagnant Film Model (SFM) for concentration polarization, as well as the Osmotic Pressure Model (OPM) and the Boundary Layer Model (BLM) for the mass transfer through the membrane. In addition, pressure drop correlations as a function of the Reynolds number are included to describe the development of the transmembrane pressure over the length of the module. The outcome of this study shows the potential to improve this multi-parameter dependent unit operation by a model-based optimization allowing significant reduction of experimental efforts and applying the Quality by Design (QbD) approach consistently. Consequently, a versatile tool for conceptual process design is presented and further application is discussed.
Highlights
For the biotechnological and pharmaceutical industry membrane-based unit operations are key process steps in order to adjust the concentration of the target component and the buffer media composition
Due to the high concentrations of the target molecules in the range of tens to hundreds of grams per liter, the solution becomes highly viscous and reaches values up to of 80 mPa·s [12]. This leads to a significant pressure drop, which may exceed the pressure limit of the ultrafiltration systems and results in a higher operation cost expenditure (OPEX)
The membrane resistance is determined by performing Clean Water Resistance Tests (CWRT) with three different single cassettes and parallel setups resistance is determined by performing CWRTs with three different single cassettes and parallel in a single stage
Summary
For the biotechnological and pharmaceutical industry membrane-based unit operations are key process steps in order to adjust the concentration of the target component and the buffer media composition This is mainly based on their mild temperature and process conditions and the low operation costs [1,2,3,4,5,6,7,8,9,10,11]. Due to the high concentrations of the target molecules in the range of tens to hundreds of grams per liter, the solution becomes highly viscous and reaches values up to of 80 mPa·s [12] This leads to a significant pressure drop, which may exceed the pressure limit of the ultrafiltration systems and results in a higher operation cost expenditure (OPEX). Another way to handle these highly concentrated solutions is by altering the geometries of the membrane channels
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