Hemogenyx Pharmaceuticals PLC Announces HEMO-CAR-T Process Qualification Run Completed
Hemogenyx Pharmaceuticals has completed its second Process Qualification run for the manufacturing of HEMO-CAR-T cells in compliant clean rooms. This step is crucial for filing an Investigational New Drug application with the FDA, necessary for starting Phase I clinical trials. The company plans to execute a minimum of three identical manufacturing runs to meet regulatory requirements. The progress underscores Hemogenyx's commitment to advancing therapies for severe blood diseases.
- Successful completion of the second Process Qualification run for HEMO-CAR-T cells.
- Progress towards filing the Investigational New Drug application with the FDA for Phase I clinical trials.
- None.
LONDON, UK / ACCESSWIRE / January 4, 2023 / 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 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.
Enquiries:
Hemogenyx Pharmaceuticals plc | https://hemogenyx.com |
Dr Vladislav Sandler, Chief Executive Officer & Co-Founder | headquarters@hemogenyx.com |
Peter Redmond, Director | peter.redmond@hemogenyx.com |
SP Angel Corporate Finance LLP | Tel: +44 (0)20 3470 0470 |
Matthew Johnson, Vadim Alexandre, Adam Cowl | |
Peterhouse Capital Limited | Tel: +44 (0)20 7469 0930 |
Lucy Williams, Duncan Vasey, Charles Goodfellow |
About Hemogenyx Pharmaceuticals plc
Hemogenyx Pharmaceuticals is a publicly traded company (LSE: HEMO) headquartered in London, with its US operating subsidiaries, Hemogenyx Pharmaceuticals LLC and Immugenyx LLC, located in New York City at its state-of-the-art research facility.
The Company is a pre-clinical stage biopharmaceutical group developing new medicines and treatments to treat blood and autoimmune disease and to bring the curative power of bone marrow transplantation to a greater number of patients suffering from otherwise incurable life-threatening diseases. Hemogenyx Pharmaceuticals is developing several distinct and complementary product candidates, as well as platform technologies that it uses as engines for novel product development.
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SOURCE: Hemogenyx Pharmaceuticals PLC
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FAQ
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