The mAb capture step represents the current bottleneck in downstream processing. Protein A resins are diffusion-limited chromatography materials that require low flow rates to achieve a binding capacity above 30 g/L, which results in low productivity. Here, we present a novel chromatography membrane that combines high binding capacities with high flow rates for increased productivity. Four different monoclonal antibodies were tested on the membrane with a standard purification protocol. Further, product quality attributes were analyzed showing comparable product quality as state-of-the-art protein A resins.
This novel technology, with its high productivity and short cycle times, purifies monoclonal antibodies with 10× less chromatography material used per batch and allows for full utilization of the membrane within one batch. Plus, as a disposable consumable, it provides the opportunity to remove column handling in bioprocesses and resin reuse over multiple batches.