Measuring product concentration is imperative during bioprocessing as concentration can be both a critical process parameter and a critical quality attribute. With the trend toward quality by design and continuous processing, there is increased necessity for inline concentration measurement outside the linear range of commonly used methods, such as ultraviolet absorption (UV).<br/>Here we report the performance of the mPath index of refraction (IoR) sensor. We demonstrate that the sensor is scalable and can operate across a comprehensive range of flow conditions expected during bioprocessing. The IoR sensor has a broad linear range, high accuracy and short response time. These attributes enable the sensor to be applied to tangential flow filtration (TFF) processes where we demonstrate successful monitoring of mAb concentration. This has the potential to eliminate the need for sampling. Additionally, as the IoR sensor has a broader dynamic range than UV, the IoR sensor enables measurement of the high concentrations typically required for mAb formulation. This ability to measure high concentrations may eliminate the requirement for over-concentration and/or offline monitoring often required for high concentration mAb formulations.<br/>In addition, we show how the IoR sensor can be applied to monitor and control chromatography processes. The concentration of the elution from a Protein A column can be accurately monitored with IoR, since it has a larger dynamic range than UV. The IoR sensor can also be used to monitor the breakthrough of mAb from Protein A columns enabling loading to a consistent 10% (w/w) breakthrough for single-column operation or to enable control of a multicolumn chromatography process.

Monitor protein concentration in real time with Pall’s inline index of refraction (IoR) system

ACS Fall 2021

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