Hemogenyx Pharmaceuticals plc is delighted to announce the successful completion of its third Process Qualification run of the end-to-end manufacturing process for its HEMO-CAR-T cells. Carried out in cGMP compliant clean rooms, the process will now be followed by analytical release tests conducted by the Company, as well as a third-party assessment, to guarantee the quality of the manufactured HEMO-CAR-T cells. This is an exciting step forward in Hemogenyx’s mission to develop new therapies and treatments for deadly blood diseases.
We are on the final stretch in our journey to obtain FDA authorization to launch Phase I clinical trials of HEMO-CAR-T. This third and final manufacturing run of the Product Qualification (PQ) is crucial and will provide the necessary data to complete the IND submission package. With successful completion of all tests and data compilation, we will be one step closer to unlocking the potential of HEMO-CAR-T.