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Precigen's UltraPorator™ Receives FDA Clearance for Manufacturing UltraCAR-T® Cells in Clinical Trials
- Technology transfer of UltraPorator to clinical sites dosing UltraCAR-T successfully completed - - UltraPorator poised to transform manufacturing and
About this update from Precigen, Inc.
[{"type":"text","content":"- Technology transfer of UltraPorator to clinical sites dosing UltraCAR-T successfully completed -\n - UltraPorator poised to transform manufacturing and accessibility of CAR-T therapies for cancer patients -\n\n\nGERMANTOWN, Md., Oct. 15, 2020 /PRNewswire/ -- Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, today announced US Food and Drug Administration (FDA) clearance and successful technology transfer for its UltraPorator™ system, an exclusive device and proprietary software solution for the scale-up of rapid and cost-effective manufacturing of UltraCAR-T® therapies. The FDA cleared UltraPorator as a manufacturing device for clinical trials of Precigen's investigational UltraCAR-T therapies in compliance with current good manufacturing practices (cGMP). In addition, the Precigen team has successfully completed technology transfer of the UltraPorator system for the manufacturing of UltraCAR-T in the ongoing clinical trials for PRGN-3005 in ovarian cancer at the University of Washington/Fred Hutchinson Cancer Research Center and for PRGN-3006 in acute myeloid leukemia (AML) at the Moffitt Cancer Center. \n\n \n \n \n \n \n \n\n \n\"UltraPorator is a game-changer for rapid manufacturing of UltraCAR-T therapy for our PRGN-3005 clinical trial,\" said Mary L. (Nora) Disis, MD, faculty member at the University of Washington and Fred Hutchinson Cancer Research Center and one of the lead investigators for the PRGN-3005 study. \"With the tech transfer process complete, we are now ready to use UltraPorator to rapidly deliver personalized UltraCAR-T therapy to patients.\" \nThe UltraPorator device is a high-throughput, semi-closed electroporation system for reprograming T-cells using Precigen's Sleeping Beauty non-viral gene transfer technology. The UltraPorator system includes proprietary hardware and software solutions and potentially represents major advancements over current electroporation devices by significantly reducing the processing time and contamination risk. UltraPorator is intended to be a viable scale-up and commercialization solution for decentralized UltraCAR-T manufacturing. The UltraPorator device was designed to enable rapid manufacturing for a range of gene and cell therapies beyond UltraCAR-T and is ava...