IP Library Granted Patent US 7,247,707
Granted Patent B2
US 7,247,707 · App. 11/434,634 · Granted Jul 24, 2007

Albumin-free factor VIII formulations

Assignees: Baxter International Inc.; University of Connecticut
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Quick Facts
Patent No.
US 7,247,707
App. No.
11/434,634
Granted
Jul 24, 2007
Kind
B2
Abstract

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.

Claims (7)

1. A Factor VIII composition without albumin, said composition made by lyophilizing an aqueous solution comprising:

Factor VIII;

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 for maintaining a pH of approximately between 6 and 8.

2. The composition of claim 1 , wherein the NaCl is present in an amount of about 400 mM.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 21, 2016
From: BAXTER INTERNATIONAL INC.
To: BAXALTA INCORPORATED; BAXALTA GMBH
Reel/Frame 038347/0243 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 24, 2007
From: BESMAN, MARC; BJORNSON, ERIK; JAMEEL, FEROZ; KASHI, RAMESH; CARPENTER, JOHN
To: BAXTER INTERNATIONAL INC.
Reel/Frame 019338/0900 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 24, 2007
From: PIKAL, MICHAEL; TCHESSALOV, SERGUEI
To: UNIVERSITY OF CONNECTICUT
Reel/Frame 019338/0932 →
Continuity (5)
Division 1061072300 · Jul 1, 2003
Continuation 0950701100 · Feb 22, 2000
Continuation In Part 0945275200 · Dec 1, 1999
Continuation In Part 0925527900 · Feb 22, 1999
Related Publication 20060205661A1 · Sep 14, 2006