FloDesign Sonics (FDS) is looking to introduce a new method of processing cells by using ultrasonic waves to remove particles from fluid dispersions.
CEO Stanley Kowalski explained how the technology works, “Our platform leverages a patented 3D acoustic wave to manipulate cell and particles in suspension. This gentle, non-invasive technology effectively suspends target cells within standing waves in a chamber while material continuously passes through the chamber.”
This technology holds advantages over traditional methods because it can achieve in one process what is usually achieved separately through filtration, centrifugation and cell selection, according to Kowalski. FDS technology is therefore able to reduce time demands related to training and tech transfer.
“Our approach is to leverage acoustics as a platform technology applied to all these areas. We feel this is differentiated in that this significantly reduces the amount of know-how required for each step. This helps to reduce time associated with training and tech transfer and can potentially streamline validation and CMC filing,” says Kowalski.
Uses and scalability
One of the purposes for which the technology could be used is in the nascent but growing CAR-T manufacturing industry, which has resulted in the company receiving financial backing by venture capital.
Kowalski told us that the technology could lower the cost of manufacturing the therapies. The cost of manufacturing the therapies is currently high and, as a result, the treatments are being priced relative to this – which is proving a barrier to market entry for the first approved therapy in the area.
In addition to the current concentrate and washing applications, this technology is showing promise in the cell selection step.
In terms of how scalable the technology is, Kowalski told us, “We have partnered with a strategic player in the bioprocess space for large scale cell harvest applications. From this application, we are confident in the scalability of this platform as we are applying it in cell therapy where the production volumes are an order of magnitude lower.”
Pall is already licensing FDS’ technology and the firm recently signed a collaboration deal with Cognate BioServices to improve manufacturing efficiencies using FDS’ acoustic cell processing platform.
The immediate next stage for FDS will be the launching of a new system, ekko, in January of next year, which will be used specifically in the concentration and washing phase.
“This is a modular platform capable of other application by changing a fluid handling unit part of the system and using a process specific single-use cartridge. The control interface is the same for all applications,” Kowalski said.