Albumin-free factor VIII formulations
A Factor VIII composition formulated without albumin, comprising the following formulation excipients in addition to Factor VIII: 4% to 10% of a bulking agent selected from the group consisting of mannitol, glycine and alanine; 1% to 4% of a stabilizing agent 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 buffering agent for maintaining a pH of approximately between 6 and 8. Alternatively, the formulation can comprise 2% to 6% hydroxyethyl starch; 1% to 4% of a stabilizing agent 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 buffering agent for maintaining a pH of approximately between 6 and 8. In a further embodiment, the formulation can comprise: 300 mM to 500 mM NaCl; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; and a buffering agent.
1. A liquid Factor VIII composition formulated without adding albumin to said composition, said composition comprising the following formulation excipients in addition to Factor VIII: 25 mM tris(hydroxymethyl)aminomethane, 4.2 mM calcium chloride, 8% (w/v) mannitol, 225 mM sodium chloride, 0.2 mg/mL glutathione, and 0.025% (w/v) polysorbate 80.
2. The composition of claim 1 , further comprising 25 mM histidine.
3. The composition of claim 2 , further comprising 2% (w/v) trehalose.
4. The composition of claims 1 to 3 , wherein the pH is between 6 and 8.
5. A liquid Factor VIII composition without albumin, said composition comprising the following formulation excipients in addition to Factor VIII: 10 mM tris(hydroxymethyl)aminomethane, 1.7 mM calcium chloride, 0.08 mg/mL glutathione, and 0.01% (w/v) polysorbate 80.
6. The composition of claim 5 , further comprising 10 mM histidine.
7. The composition of claim 6 , further comprising 1% trehalose.
8. The composition of claim 7 , further comprising 4% (w/v) mannitol.
9. The composition of claim 8 , further comprising 100 mM sodium chloride.
10. The composition of any of claims 5 to 9 , wherein the pH is between 6 and 8.