abstract |
A therapeutic factor VIII formulation that is stable in the absence of albumin or other proteins. In addition to Factor VIII, the following formulation excipients: 4% to 10% filler selected from the group consisting of mannitol, glycine, and alanine; 1% to 4% stabilizer selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; 100 mM to 300 mM NaCl; and a buffer to maintain a pH of about 6-8; A factor VIII composition formulated without the addition of albumin. [Selection figure] None |