DSM Pharmaceutical Products has signed a manufacturing agreement with Sanquin Blood Supply Foundation in The Netherlands for the commercial supply of a monoclonal antibody used for the recovery and purification of coagulation factor IX from human blood. Sanquin’s Nonafact was the first factor IX product to receive EMA approval in 2001 to treat bleeding in patients with hemophilia B. With this agreement DSM becomes a second supplier to Sanquin for this process intermediate, which is used for capture of human factor IX from blood plasma.
DSM Biologics, a business unit of DSM Pharmaceutical Products, has already begun the technology transfer. The collaboration will entail a subsequent GMP manufacture of the anti-factor IX mAb at DSM Biologics' facilities in Groningen, The Netherlands.
Manja Bouman, president of DSM Biologics, said, "We are delighted to be working with Sanquin on manufacturing this important product and providing security of supply for patients in need. DSM Biologics will bring over 27 years of manufacturing experience, state-of-the-art facilities and a global team of experts to help drive the success of one of Sanquin's lead products."
Gelmer Leibbrandt, Unit-director of marketing and sales at Sanquin Plasma Products, said, “There is an unmet medical need for coagulation factors in the hemophilia community. We see an ever-increasing demand for Nonafact. A guaranteed availability of our product is needed to act as a reliable supplier to the patients, that’s why we are delighted to cooperate with DSM to support us with their supply of this crucial anti-factor IX mAb.”