The acoustic wave separation (AWS) system uses a three-dimensional standing wave to trap and gather cells in the flow channel, bridging the gap between the fermentation and purification process in single-use systems.
On Monday at the Achema trade show in Frankfurt, Germany, Pall Corporation announced it had bought the rights to the technology for use in cell clarification and perfusion, and Biopharma-Reporter was there to find out more.
“This is essentially a ‘filterless filter’,” said John Rozembersky, FloDesignSonics’ Vice President showcasing the AWS Sytem at Pall’s booth. “The system generates sound waves which grab particles and drives them together to form ‘snowball-like’ clusters that are so heavy they fall to the bottom, leaving the clarified liquid to escape at the top.”
Perfusion systems can culture cells continuously for up to 90 days, but the biggest challenge is keeping the process going into the downstream train. But by not having a filter that would need unclogging – and therefore stopping the process - the AWS system avoids this and opens the door to fully continuous bioprocessing.
“The device, as we see it, has no major technical hurdles to becoming a valuable technology to enable continuous processing,” Chris Leidel, VP of Operations at FloDesignSonics told us.
“Unlike TFF [tangential-flow filtration] or ATF [alternating tangential flow-based systems] there is no fouling or clogging of a membrane, no media or cartridges to be replaced and it can run continuously for as long as needed. It is extremely gentle of the cells with very little shear forces so no effect on viability or productivity.”
Filtration and separation firm Pall - set to be acquired by Danaher for $14bn - has the exclusive rights to manufacture sell, and support the technology for use in cell clarification and perfusion, and is planning to introduce a single-use product line using AWS technology for the clarification of cell culture at both bench scale and GMP scale.