The CAS provides cell and protein yields in a closed system without centrifugation and is capable of clarifying several types of biologic products, including recombinant therapeutic proteins and monoclonal antibodies.
“As the industry is moving toward higher cell densities and lower viabilities, the depth filtration area required is getting extremely large and you’re running into floor space limitations,” Ron Farkash, R&D Director, Tangential Flow Filtration, Pall Life Sciences, told us at Interphex.
According to Farkash, the CAS’s main selling point is that it provides a robust process and high productivity with less floor space. Additionally, “one of the unique aspects of this is that it’s a filterless filter, so it doesn’t clog, or change performance over time,” he said.
The product works by applying acoustic forces across a countercurrent flow of bioprocess fluid. This process creates three-dimensional standing waves that trap cells at their nodes, which leads to aggregation and precipitation from suspension.
“It traps, agglomerates, and collects cells in a continuous fashion,” explained Farkash.
This is a new application of sonic separation, according to Farkash, who explained that while there was a previous product that used sonics to separate, it was a discontinuous process, which had several disadvantages.
“The big advantage of our product is that it’s a multidimensional waveform. It can run for 8 hours with stable performance with no change in conditions and you don’t need to do any manipulations of shutting pumps offs or drawing off cells,” said Farkash. “This is completely new patent protected sonic application that has very significant benefits over previous products.”
The company obtained an exclusive license to the acoustic wave separation technology in June 2015; however, the technology wasn’t commercialized until recently. “Now we’re bringing it to market,” said Farkash, “Taking it out of the lab and into the world.”
The company received a “tremendous amount of interest” in the real world at Interphex last month, yet Farkash believes that using the technology for batch harvest is “going after low hanging fruit.”
“With any new technologies there’s always additional learning and there’s always additional applications you hadn’t thought about,” added Farkash, who added that the company continues to explore other applications.
“There are a lot of other applications within perfusion and continuous processing that we’re just staring to explore,” he said. “This is the front edge of the next wave.”