Idogen has announced that the company’s technology platform for tolerogenic dendritic cell generation has been successfully advanced from pilot to production-scale.
Results from completed tests show that the technology platform can now generate functional cells in considerably larger volumes than previously possible, states the company. As the next step, Idogen now initiates the partnership with Radboud University Medical Center in the Netherlands, to establish cell production meeting Good Manufacturing Practice (GMP) requirements prior to upcoming clinical trials.
Idogen’s tolerogenic cell therapy is based on dendritic cells, a type of white blood cell that plays a key role in the immune system by controlling the response of other immune cells to the body’s own and foreign molecules and tissues. The company’s most advanced project, IDO 8, is designed to restore the efficacy of haemophilia drugs in patients who have developed neutralising antibodies. The IDO T project is being developed to prevent kidney transplant rejection.
Show the scalability
Recently, Idogen has evaluated and documented a range of methods for scaling up the company’s production. That is creating flexibility prior to selection of the method to be used for manufacturing the materials for the planned clinical trials for the company’s cell therapy projects. All of the methods are compatible with the GMP-certified production system that is available from the company’s partner, the Radboud University Medical Center.
“The fact we have now been able to show the scalability in the generation of our cell therapy products is a major success because it significantly reduces the level of risk in our projects. Our partner, Radboud University, is a global leader in the field and will assist us in our ongoing efforts to establish a GMP-certified manufacturing process prior to starting clinical trials,” says Hanne Risager Romedahl, Chief Scientific Officer at Idogen.
Photo: Kennet Rouna