DSM Pharmaceutical Products signed an agreement for commercial supply with Netherlands-based Sanquin Blood Supply Foundation covering the manufacture of a monoclonal antibody used to recover and purify coagulation factor IX from human blood.
The firms say that collaboration between DSM Biologics, a business unit of DSM Pharmaceutical Products, and Sanquin has already begun with technology transfer and will lead to GMP manufacturing of the anti-factor IX mAb at DSM Biologics' facilities in Groningen, The Netherlands.
Factor IX is a protein produced naturally in the body that helps blood clots form. Sanquin says that their Nonafact®, which is administered to prevent and treat bleeding in patients suffering from hemophilia B, was the first factor IX product that received EMA approval in 2001. DSM was tapped as a second supplier of the anti-factor IX mAb for an important intermediate process used to capture factor IX from blood plasma and also because of increasing interest from the international markets.
"There is an unmet medical need for coagulation factors in the hemophilia community," said Gelmer Leibbrandt, unit-director, marketing & sales of Sanquin Plasma Products, in a statement. "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."