Date: 2013-10-24
Type of information: Production agreement
Compound: monoclonal antibody used for the recovery and purification of coagulation factor IX from human blood
Company: Royal DSM (The Netherlands) Sanquin Blood Supply Foundation (The Netherlands)
Therapeutic area: Hematological diseases - Genetic diseases - Rare diseases
Type agreement: manufacturing
production
Action mechanism:
Disease:
Details: * On October 24, 2013, DSM Pharmaceutical Products, the custom manufacturing and technology business of Royal DSM, has announced that it has signed a manufacturing agreement for commercial supply with Sanquin Blood Supply Foundation. 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.
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