Pall obtained an exclusive license for acoustic wave separation (AWS), a disruptive technology from FloDesign Sonics for cell culture clarification for both fed-batch and perfusion applications. Pall officials say the technology was attractive because it enables high-efficiency continuous removal of the cells in a closed system without centrifugation, thus streamlining a challenging step in the biologics manufacturing process within a small operating footprint.
The technology will complement Pall's STAXTM depth filtration products to enable continuous clarification of cell culture, enabling integration of the bioreactor with downstream processing, according to Michael Egholm, president of Pall Biopharmaceuticals.
The AWS technology works by applying acoustic forces across a flow channel to generate a three-dimensional standing wave. When a cell culture passes through the flow channel, the cells are trapped at the nodes of the acoustic waves and then aggregate, culminating in their precipitation from suspension as their buoyancy decreases. Important features are no temperature increase, no damage to cells or proteins, and the process works in a robust manner at high yields, notes Egholm, who adds that the integration of the AWS technology expands the portfolio of continuous bioprocessing and single-use products offered by Pall. The company recently acquired the BioSMB® multicolumn continuous chromatography platform from Tarpon Biosystems.
“This approach helps to bridge the critical gap between bioreactor and the downstream processing train,” points out Egholm. “The AWS products will eliminate the reliance on centrifugation for cell culture clarification, and will provide a continuous feed stream for direct integration with the BioSMB platform.”
Pall plans to introduce a single-use product line using AWS technology for the clarification of cell culture at both bench scale and GMP scale to match pilot and production bioreactor volumes, with predictable and reproducible performance over a wide range of cell densities.