PARIS — The MAK cell processor from Immuno-Designed Molecules (IDM) has received CE marking, which allows the device to be marketed in all 15 member states of the European Union. In addition, IDM received ISO 9000 clearance, with its manufacturing and production facilities having achieved ISO 9002 status.
"Being in Phase II clinicals with a CE-marked product and having ISO 9000 certification were the final milestones we had targeted in our 1997 plan. It is now done and on target," said Yves Fouron, president and CEO of IDM, in Paris.
"Hitting one of those goals would be significant for any company. Achieving both in four years is a major accomplishment — one we are all proud of at IDM," he added.
The MAK (macrophage-activated killer) cell processor is a single-use mechanical device that includes all required chemicals, reagents, equipment and integrated software controls to produce activated macrophages on a patient-dedicated basis. The cell processor is self-contained and comes ready to use. It is designed to process mononuclear cells derived from peripheral blood from initial apheresis to final re-injection into the patient of activated macrophages.
Jean-Loup Romet-Lemonne, executive vice president in charge of medical and scientific affairs at IDM, explained, "A key feature of all IDM cell processors is their dedicated computer software which guides the user through each step of the SOPs [standard operating procedures]." Romet-Lemonne added, "This provides a very high level of quality assurance, quality control, traceability and reproducibility to our products, which is unique in the field." — Tom Clark