The patent badge is an abbreviated version of the USPTO patent document. The patent badge does contain a link to the full patent document.

The patent badge is an abbreviated version of the USPTO patent document. The patent badge covers the following: Patent number, Date patent was issued, Date patent was filed, Title of the patent, Applicant, Inventor, Assignee, Attorney firm, Primary examiner, Assistant examiner, CPCs, and Abstract. The patent badge does contain a link to the full patent document (in Adobe Acrobat format, aka pdf). To download or print any patent click here.

Date of Patent:
Jun. 06, 2017

Filed:

May. 04, 2016
Applicants:

Baxalta Incorporated, Bannockburn, IL (US);

Baxalta Gmbh, Glattpark (Opfikon), CH;

University of Connecticut, Farminton, CT (US);

Inventors:

Marc Besman, Studio City, CA (US);

Erik Bjornson, Studio City, CA (US);

Feroz Jameel, Covina, CA (US);

Ramesh Kashi, Walnut, CA (US);

Michael Pikal, Mansfield Center, CT (US);

Serguei Tchessalov, Ashford, CT (US);

John Carpenter, Littleton, CO (US);

Assignees:

Baxalta Incorporated, Bannockburn, IL (US);

Baxalta GmbH, Glattpark (Opfikon), CH;

University of Connecticut, Farmington, CT (US);

Attorney:
Primary Examiner:
Int. Cl.
CPC ...
A61K 38/37 (2006.01); A61K 47/02 (2006.01); A61K 47/26 (2006.01); A61K 47/18 (2017.01);
U.S. Cl.
CPC ...
A61K 38/37 (2013.01); A61K 47/02 (2013.01); A61K 47/183 (2013.01); A61K 47/26 (2013.01);
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.


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