FloDesign Sonics, an innovator and developer of acoustic bioprocessing technologies, announced a technology co-development deal with a large pharmaceutical corporation to commercialise acoustic-based unit operations in both concentration-wash and acoustic affinity cell separation
FloDesign Sonics (FDS) will work with the customer’s CAR-T process development group to design, develop and deliver modular acoustic processing hardware for the two separate unit operations at multiple scales.
Acoustic cell processing is a unique technology for the gentle manipulation of cells and can provide many potential benefits. FDS is now looking to develop the technology further through industry partnerships and early-adopter trials of pre-commercial units for users who wish to evaluate and run proof-of-performance trials on acoustic unit operations.
The acoustic cell processing platform takes a modular approach by using the same bench-top hardware to run different disposable elements tailored to specific process parameters.
Acoustic concentration-wash elements can achieve very high concentration factors at a broad range of scales, while providing high recoveries and extremely low cell stress. Acoustic affinity separation uses acoustically optimised, non-magnetic particles for highly-specific cell selections that run at process-scale throughputs.
All unit operations employ closed systems, automation and integration of the fluid handling steps, paving the way to commercial manufacturing.
“The most critical step in our journey to optimise AWS technology for this industry has been taken. With validation complete, we are now focused on scale-up and scale-out of the AWS technology for autologous or allogeneic cell therapies,” said FDS president, Stanley Kowalski.
“As we take this next step in our development, we are interested in aligning with leading-edge companies to scale AWS for the full spectrum of cell culture feed volumes, cell types, and cell concentrations of various cell therapies.”
FDS goal is to provide the cell and gene therapy industry with high-performance process tools that are modular, automated and cost-effective, to successfully bring life-changing therapeutics to market.