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:
Apr. 15, 2014

Filed:

Jul. 19, 2011
Applicants:

Matthew Seefeldt, Denver, CO (US);

Theodore W. Randolph, Niwot, CO (US);

Amber Haynes Fradkin, Golden, CO (US);

John Carpenter, Denver, CO (US);

Inventors:

Matthew Seefeldt, Denver, CO (US);

Theodore W. Randolph, Niwot, CO (US);

Amber Haynes Fradkin, Golden, CO (US);

John Carpenter, Denver, CO (US);

Assignees:

The Regents of the University of Colorado, Denver, CO (US);

Barofold, Inc., Aurora, CO (US);

Attorney:
Primary Examiner:
Assistant Examiner:
Int. Cl.
CPC ...
C07K 14/00 (2006.01); C07K 1/00 (2006.01); C07K 16/00 (2006.01); A61K 38/00 (2006.01); A61K 39/00 (2006.01);
U.S. Cl.
CPC ...
Abstract

The present invention provides methods for reducing and/or evaluating the immunogenic potential of a therapeutic protein preparation. The present invention further provides pharmaceutical compositions of therapeutic proteins and methods of treatment with the same, the compositions having low immunogenic potential and/or improved efficacy. The invention achieves these goals by evaluating therapeutic protein preparations for subvisible protein particulates, which can contribute significantly to the overall immunogenic potential of the protein preparation. Further, by maintaining the content of such subvisible protein particulates to below an immunogenic threshold level, the resulting pharmaceutical composition is less likely to result in a loss of tolerance (e.g., upon repeated administration), thereby improving both the safety and efficacy profile of the therapeutic.


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