Abstract: The present invention relates to a pharmaceutical composition comprising Factor VIII and the divalent metal ions Zn2+ and Cu2+, optionally in the presence of Ca2+ ions and/or Mn2+ ions, wherein said Factor VIII is stable without the addition of albumin. The invention also relates to a method for the production of recombinant Factor VIII from mammalian cells carrying the gene therefor, comprising culturing said mammalian cells in medium free of plasma-derived protein and supplemented with divalent metal ions, including Cu2+ and Zn2+, and optionally in the presence of Ca2+ and Mn2+ ions.

Abstract: The present invention relates to a pharmaceutical formulation for subcutaneous, intramuscular or intradermal administration comprising coagulation factor VIII or factor IX and use thereof for manufacture of a medicament for treating haemophilia A or B. The formulation comprises coagulation factor VIII or factor IX with an activity of at least 200 IU/ml and an additive increasing the bio-availability of factor VIII or factor IX. Tests with factor VIII gives a therapeutic level of active factor VIII in the blood stream for a surprisingly long period of time after subcutaneous, intramuscular or intradermal administration. The factor VIII is suitably a highly purified recombinant factor VII, and preferably a deletion derivative thereof, which can be used for the manufacture of a medicament for subcutaneous administration.