DSM Pharmaceutical Products, the custom manufacturing and technology business of Royal DSM announced that it has signed a manufacturing agreement for commercial supply with Sanquin Blood Supply Foundation, The Netherlands.
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. Read the full release