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. 11, 2019

Filed:

Feb. 19, 2016
Applicant:

Hoffmann-la Roche Inc., Little Falls, NJ (US);

Inventors:

Sabine Bertl, Iffeldorf, DE;

Harald Duerr, Starnberg, DE;

Andreas Schaubmar, Penzberg, DE;

Assignee:

Hoffmann-La Roche Inc., Little Falls, NJ (US);

Attorney:
Primary Examiner:
Assistant Examiner:
Int. Cl.
CPC ...
C07K 16/46 (2006.01); C07K 1/22 (2006.01); C07K 1/18 (2006.01); B01D 15/38 (2006.01); C07K 1/16 (2006.01); C07K 16/00 (2006.01); C07K 16/22 (2006.01); C07K 16/24 (2006.01); C07K 16/28 (2006.01); B01D 15/36 (2006.01);
U.S. Cl.
CPC ...
C07K 1/18 (2013.01); B01D 15/362 (2013.01); B01D 15/3809 (2013.01); C07K 1/22 (2013.01); C07K 16/00 (2013.01); C07K 16/22 (2013.01); C07K 16/244 (2013.01); C07K 16/2863 (2013.01); C07K 16/2875 (2013.01); C07K 16/468 (2013.01); C07K 2317/31 (2013.01); C07K 2317/51 (2013.01); C07K 2317/52 (2013.01); C07K 2317/55 (2013.01); C07K 2317/66 (2013.01);
Abstract

The present invention is directed to methods comprising the use of hydroxyapatite chromatography to separate a bispecific antibody from a solution that also comprises one or more byproducts specific to bispecific antibody production. Byproducts specific to the production of bispecific antibodies (bispecific antibody specific byproducts, 'BASB') include fragments of the bispecific antibody and heavier molecular weight variants of the antibody, wherein the fragment and/or variant comprises an Fc domain but does not exhibit affinity for the two different epitopes and/or antigens as exhibited by the desired bispecific antibody. Thus, the methods of the present invention comprise the separation of a bispecific antibody from one or more of its BASB. The hydroxyapatite chromatography methods of the invention may be used alone or may be further combined with standard purification processes and unit operations as is known in the art to achieve any level of purity of bispecific antibody necessary, e.g., for therapeutic and/or diagnostic applications.


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