Cesca Therapeutics Inc., a market leader in automated cell processing and autologous cell therapies for regenerative medicine, and ThermoGenesis, its wholly owned device subsidiary have reported Validations of System Performance for their X-Series® products from two prestigious academic medical centers: Marcus Center for Cellular Cures at Duke University School of Medicine and Lineberger Comprehensive Cancer Center at the University of North Carolina.
Cesca Therapeutics Inc., founded in 1986, headquartered in Rancho Cordova, California, USA, develops, commercializes and markets a range of automated technologies for CAR-T and other cell-based therapies. Its device division, ThermoGenesis, develops, commercializes and markets a full suite of solutions for automated clinical biobanking, point-of-care applications, and automation for immuno-oncology. The Company has developed a semi-automated, functionally closed CAR-TXpress™ platform to streamline the manufacturing process for the emerging CAR-T immunotherapy market.
X-Wash® System: An abstract, entitled, “Source Cell Preparation for the Manufacture of DUOC-01 Using a Closed System Cell-Processing Device,” was published in the supplement for Cord Blood Connect: The International Congress for Cord Blood and Perinatal Tissue Research and Banking, in the journal Stem Cells Translational Medicine. The meeting where the research was presented took place September 13-15. DUOC-01 is a cell product derived from cord blood CD14 monocytes, currently being studied in a clinical trial in pediatric patients with inherited leukodystrophies.
Since the clinical benefit of the DUOC-01 population of cells is improved when the contaminating red cells and DMSO cryoprotectant are depleted from the thawed cord blood unit, principal author, Dr. Joanne Kurtzberg, and her co-authors at the Duke University School of Medicine, tested whether the semi-automated, “closed-system” X-WASH could accomplish this precision purification typically pursued with labor intensive “open-system” manual processes requiring the use of density gradients and performed under a sterile hood.
A total of 33 thawed units of cord blood were prepared for the manufacture of a DUOC-01 cell population and the authors concluded: “The X-WASH device allows for washing of thawed cord blood in a closed system without adding density gradient solutions and proved to be reliable and consistent across varying CBU volumes for RBC removal and TNC recovery as needed for the manufacture of DUOC-01.”
CAR-TXpress™ System: The ISCT NA Top Scoring Technologist Abstract Award Recipient, “Validation of ThermoGenesis CAR-TXpress™ System for Activation in Scale-up CAR T cell Production,” authored by Todd Maguire, Paul Eldridge, Barbara Salvodo and Kathryn McKay of the Lineburger Advanced Cellular Therapeutics Facility, was presented at the ISCT North America regional conference on September 13, 2019.
The authors reported on the use of all three semi-automated devices, X-LAB® to harvest MNCs from blood, X-WASH to wash DMSO, growth factors, cell debris, free viruses, etc. from cells and X-BACS™ to select, harvest and activate T-cells with buoyant microbubbles.
The authors concluded: “The results of three experimental runs described indicate that T lymphocytes prepared with the CAR-TXpress System are comparable to a previous validated manual method. The advantages of scale, reduction in the number of operator steps and closed system processes are attractive features of the system. Additional validation work will be needed to qualify the system, but it has useful potential and is amenable to function across a spectrum of scale for early to later phase production efforts.”