Business
HEMO-CAR-T First PQ Run Completed
HEMO-CAR-T First PQ Run Completed.
About this update from Hemogenyx Pharmaceuticals Plc
[{"type":"text","content":"\n \n \n 12 December 2022\n \n \n \n \n \n Reach - Non-Regulatory\n \n \n \n \n \n \n \n \n Hemogenyx Pharmaceuticals plc\n \n \n \n \n (\"Hemogenyx Pharmaceuticals\" or the \"Company\")\n \n \n \n \n HEMO-CAR-T First Process Qualification Run Completed\n \n \n \n Hemogenyx Pharmaceuticals plc (LSE: HEMO), the biopharmaceutical group developing new therapies and treatments for deadly blood diseases, is pleased to announce the successful completion of its first Process Qualification (\"PQ\") run of the end-to-end process for the manufacture of HEMO-CAR-T cells. This PQ run is one of a minimum of three identical manufacturing runs required for the submission of the Investigational New Drug (\"IND\") application to the US Food and Drug Administration (\"FDA\"). The process was carried out in the Company's current Good Manufacturing Practice (\"cGMP\") compliant clean rooms. It was followed by a battery of analytical release tests required to verify the quality of the manufactured HEMO-CAR-T cells.\n \n \n This is another step for the Company in its preparation of the IND application to the FDA required to authorize commencement of Phase I clinical trials of HEMO-CAR-T.\n \n \n \n \n \n \n Enquiries:\n \n \n \n \n \n \n \n \n \n \n \n \n \n Hemogenyx Pharmaceuticals plc\n \n \n \n \n \n \n https://hemogenyx.com\n \n \n \n \n \n \n \n Dr Vladislav Sandler, Chief Executive Officer & Co-Founder\n \n \n \n \n \n [email protected]\n \n \n \n \n \n \n \n Peter Redmond, Director\n \n \n \n \n \n [email protected]\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n SP Angel Corporate Finance LLP\n \n \n \n \n \n Tel: +44 (0)20 3470 0470\n \n \n \n \n \n \n Matthew Johnson, Vadim Alexandre, Adam Cowl\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n Peterhouse Capital Limited\n \n \n \n \n \n Tel: +44 (0)20 7469 0930\n \n \n \n \n \n \n Lucy Williams, Duncan Vasey, Charles Goodfellow\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n About Hemogenyx Pharmaceuticals plc\n \n \n \n Hemogenyx Pharmaceuticals is a publicly traded company (LSE: HEMO) headquartered in London, with its US operating subsidiaries, Hemogenyx ...