Robust and Scalable MAb Capture Facilitated by a Novel Convecdiff Membrane Structure

Alternative stationary phases are being developed to solve the shortcomings of bead chromatography processes, namely high diffusional resistance leading to long processing cycles (4–6 h). Targeted lifetimes of 75–150 bind and elute cycles, taking sometimes years to achieve and requiring cleaning and respective validation, storage, and column unpacking and repacking, elevate costs and introduce increasingly unacceptable bioburden risks.

Chromatographic membranes, due to intrinsically high mass transfer rates, overcome these limitations, enabling residence times of seconds and full lifetime utilization (75–150 cycles) in 1–2 shifts.

Here, we present a novel chromatographic membrane platform based on a functionalized, self-structured hydrogel with high specific binding capacities. The membrane exhibits short diffusional path lengths, providing fast mass transfer and thus high dynamic binding capacities even for large proteins. Large convective pores (4–6 µm) transport those target molecules to the hydrogel interphase with low fouling and high permeability, easing cleanability and providing the basis for uncompromised scalability.

We will introduce the structural features of this novel chromatographic membrane material and explain how these are connected to its chromatographic performance and how it differs in those aspects from purely convective separation materials. Further, we will show how this membrane delivers uncompromised scalability over the entire device portfolio, as well as robust cycling performance.

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