Progress On A Fully Disposable Downstream Platform: A Simple, Risk-Free, Plug-in Solution To Solve The DSP Bottleneck

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Natrix HD Membrane technology features a polymeric hydrogel formed within a flexible porous support matrix. The support matrix provides mechanical strength, while the hydrogel properties determine the separation chemistry of the product. An advantage of the Natrix chemistry is the ability to place virtually any functional group chemistry throughout the hydrogel polymer.

Natrix HD membrane technology combines the superior binding capacity of conventional resinbased columns with the high throughput of membranes in a single-use format that eliminates costly packing, cleaning, validating and other burdens of conventional methods.

This poster highlights progress to date with a fully disposable process that competes well against a ProA process for mAbs. Two different device formats and chemistries are discussed: The first is a positive binding format using weak cation exchange chemistry to capture mAb from clarified cell culture. The second format is negative binding flow through strong anion exchange as a final polish for finishing removal/reduction of impurities in the mAb process prior to formulation as drug substance. Comparison data and calculations showing process efficiency and differences between a ProA process and a Natrix non-ProA process are also provided.