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New patent for automated cell processing technology provides commercially viable automated CMC solution for developing CAR-T cell therapies.
On July 28, 2017, Cesca Therapeutics, a US-based company specializing in automated cell processing, announced that the US Patent and Trademark Office has awarded a new US Patent, No. 9,695,394 (the ‘394 patent), entitled Cell Separation Devices, Systems, and Methods. The patent relates to the automated isolation of rare, therapeutically critical target cells from blood, bone marrow, leukapheresis product, and other cell sources, while maintaining the viability of the cells under aseptic conditions. The patent was awarded to SynGen, whose cell processing assets were acquired on July 10, 2017 by ThermoGenesis, Cesca’s 80%-owned device subsidiary.
This technology is part of Cesca’s proprietary CAR-TXpress platform that now integrates multi-component automation steps, including T-cell isolation, purification, culture expansion and washing, and single cassette-based automated -196 °C cryopreservation and retrieval. The CAR-TXpress system provides a commercially viable, automated cellular manufacturing and control (CMC) solution for the development of CAR-T and CAR-NK therapeutics.
This new patent covers a device and methodology for integrating automated cellular separation and buoyancy-activated cell sorting (BACS) processes. BACS uses microscopic bubbles to isolate a specific cell type from a complex mixture of cells, such as blood. These microbubbles bear antibodies on their surface, enabling them to bind specifically to a single target cell type. When coated with microbubbles, the target cells float to the top of the host liquid, while non-target cells sink to the bottom-a process that can be accelerated by centrifugation. Subsequent collection of the floating target cell layer and release of the cells from their microbubbles provides a highly purified preparation of just the cells of interest, with significant recovery efficiency while retaining cell viability. Additionally, the patent allows for the automated isolation of cells with low density surface antigens, which was previously a major cellular manufacturing challenge.
“Traditional cell processing methodologies, including those currently being implemented and used by leading CAR-T developers, are manual and time consuming, presenting significant challenges to the future largescale commercial feasibility of these revolutionary therapies. In contrast, Cesca’s patented, automated cell processing systems provide greater cell yields and higher consistency in a fraction of the time, making them ideally suited to meet industry needs. The ability to leverage our technology to commercialize the BACS process is a milestone achievement for our company,” said Chris Xu, Cesca’s CEO, in a company press release.
“Cesca’s unique CAR-TXpress cell processing solution begins with BACS-based cell isolation technology to provide the ultra-high levels of cell purity, recovery, and viability of target immune cells from donor blood that therapeutic cell manufacturers increasingly demand,” said Philip Coelho, chief technology officer of ThermoGenesis and co-inventor of the ‘394 patent, in a company press release. “Unlike conventional cell isolation technologies that work on narrow streams of slowly moving suspended cells, our BACS-enabling technology works in bulk volumes of cells, dramatically reducing processing time. With these advantages, we look forward to partnering with leading CAR-T developers as they strive to bring these groundbreaking therapies to patients suffering from cancer and other serious diseases.”
Source: Cesca Therapeutics