The agreement covers the commercial manufacture of a monoclonal antibody used for the recovery and purification of coagulation factor IX from human blood. Factor IX is a protein produced naturally in the body, which helps the blood form clots to stop bleeding. Collaboration between DSM Biologics, a business unit of DSM Pharmaceutical Products, and Sanquin has already started with technology transfer and will entail a subsequent GMP manufacture of the anti-factor IX mAb at DSM Biologics' facilities in Groningen, The Netherlands.
Nonafact® was the first factor IX product that received EMA approval in 2001. Nonafact® is administered to prevent and treat bleeding in patients suffering from hemophilia B (a congenital lack of active Factor IX). A deficiency of Factor IX causes blood coagulation problems, which may lead to bleeding in joints, muscles or internal organs. Due to increasing interest from the international markets a second supplier of the anti-factor IX mAb is needed. With this agreement DSM has become a second supplier to Sanquin for an important process intermediate which is used for capture of human factor IX from blood plasma.
Manja Bouman, President of DSM Biologics, commented "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 Marketing & Sales of Sanquin Plasma Products, says: “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.”