DSM Biologics, a business unit of DSM Pharmaceutical Products, and Sanquin have collaborated for 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.
Both the companies started 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."
Nonafact is a registered trademark of Sanquin.
Sanquin is responsible for blood supply on a not-for-profit basis and advances transfusion medicine as such that it fulfills the highest demands for quality, safety and efficiency. Sanquin delivers products and diagnostic services, conducts scientific investigations and provides education, instruction, in-service training and refresher courses.
Royal DSM is a global science-based company active in health, nutrition and materials. DSM delivers innovative solutions that nourish, protect and improve performance in global markets such as food and dietary supplements, personal care, feed, pharmaceuticals, medical devices, automotive, paints, electrical and electronics, life protection, alternative energy and bio-based materials.