The agreement covers the commercial manufacture of a monoclonal antibody used for the recovery and purification of coagulation factor IX from human blood
DSM Pharmaceutical Products, the custom manufacturing and technology business of Royal DSM, has signed a manufacturing agreement for commercial supply of a monoclonal antibody with Sanquin Blood Supply Foundation in 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.
The two companies have already begun technology transfer and will subsequently manufacture the anti-factor IX mAb at DSM Biologics' facilities in Groningen, The Netherlands.
Sanquin's Nonafact was the first factor IX product to receive EMA approval in 2001. This product is administered to prevent and treat bleeding in patients suffering from haemophilia B, a congenital lack of active Factor IX, which causes blood coagulation problems and may lead to bleeding in joints, muscles or internal organs.
Due to increasing interest from international markets, a second supplier of the anti-factor IX mAb is needed and with this agreement, DSM has become that supplier.
Gelmer Leibbrandt, Unit-director Marketing & Sales of Sanquin Plasma Products, said: 'There is an unmet medical need for coagulation factors in the haemophilia 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 co-operate with DSM.'