Invention Grant
- Patent Title: Albumin-free factor VIII formulations
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Application No.: US15146835Application Date: 2016-05-04
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Publication No.: US09669076B2Publication Date: 2017-06-06
- Inventor: Marc Besman , Erik Bjornson , Feroz Jameel , Ramesh Kashi , Michael Pikal , Serguei Tchessalov , John Carpenter
- Applicant: Baxalta Incorporated , Baxalta GmbH , University of Connecticut
- Applicant Address: US IL Bannockburn CH Glattpark (Opfikon) US CT Farmington
- Assignee: Baxalta Incorporated,Baxalta GmbH,University of Connecticut
- Current Assignee: Baxalta Incorporated,Baxalta GmbH,University of Connecticut
- Current Assignee Address: US IL Bannockburn CH Glattpark (Opfikon) US CT Farmington
- Agency: Morgan, Lewis & Bockius LLP
- Main IPC: A61K38/37
- IPC: A61K38/37 ; A61K47/02 ; A61K47/26 ; A61K47/18

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.
Public/Granted literature
- US20170000854A1 NOVEL ALBUMIN-FREE FACTOR VIII FORMULATIONS Public/Granted day:2017-01-05
Information query
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