Hemogenyx Pharmaceuticals PLC Announces HEMO-CAR-T Process Qualification Run Completed

Jan 04, 2023

LONDON, UK / ACCESSWIRE / January 4, 2023 / Hemogenyx Pharmaceuticals plc (LSE:HEMO, Financial), the biopharmaceutical group developing new therapies and treatments for deadly blood diseases, is pleased to announce the successful completion of its second Process Qualification ("PQ") run of the end-to-end process for the manufacture of HEMO-CAR-T cells. 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.

This PQ run is the second of minimum three identical manufacturing runs required for the submission of an Investigational New Drug ("IND") application to the US Food and Drug Administration ("FDA"). The IND is needed to obtain authorization from the FDA to commence Phase I clinical trials of HEMO-CAR-T.

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