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:
Aug. 25, 2020

Filed:

Jun. 24, 2019
Applicant:

Genentech, Inc., South San Francisco, CA (US);

Inventors:

Michael Adler, Riehen, CH;

Hanns-Christian Mahler, Basel, CH;

Oliver Boris Stauch, Freiburg, DE;

Assignee:

GENENTECH, INC., South San Francisco, CA (US);

Attorney:
Primary Examiner:
Int. Cl.
CPC ...
A61K 39/395 (2006.01); C07K 16/28 (2006.01); A61K 9/00 (2006.01); A61K 9/19 (2006.01); A61K 47/10 (2017.01); A61K 47/18 (2017.01); A61K 47/26 (2006.01); A61K 38/47 (2006.01); A61K 45/06 (2006.01); A61K 47/20 (2006.01); A61K 47/22 (2006.01); A61K 47/42 (2017.01); C07K 16/30 (2006.01); A61K 39/00 (2006.01);
U.S. Cl.
CPC ...
C07K 16/2887 (2013.01); A61K 9/0019 (2013.01); A61K 9/19 (2013.01); A61K 38/47 (2013.01); A61K 39/3955 (2013.01); A61K 45/06 (2013.01); A61K 47/10 (2013.01); A61K 47/183 (2013.01); A61K 47/20 (2013.01); A61K 47/22 (2013.01); A61K 47/26 (2013.01); A61K 47/42 (2013.01); C07K 16/3061 (2013.01); A61K 2039/505 (2013.01); C07K 2317/21 (2013.01); C07K 2317/24 (2013.01); C07K 2317/734 (2013.01); C07K 2317/94 (2013.01);
Abstract

The present invention relates to a highly concentrated, stable pharmaceutical formulation of a pharmaceutically active anti-CD20 antibody, such as e.g. Rituximab, Ocrelizumab, or HuMab<CD20>, or a mixture of such antibody molecules for subcutaneous injection. In particular, the present invention relates to formulations comprising, in addition to a suitable amount of the anti-CD20 antibody, an effective amount of at least one hyaluronidase enzyme as a combined formulation or for use in form of a co-formulation. The said formulations comprise additionally at least one buffering agent, such as e.g. a histidine buffer, a stabilizer or a mixture of two or more stabilizers (e.g. a saccharide, such as e.g. α,α-trehalose dihydrate or sucrose, and optionally methionine as a second stabilizer), a nonionic surfactant and an effective amount of at least one hyaluronidase enzyme. Methods for preparing such formulations and their uses thereof are also provided.


Find Patent Forward Citations

Loading…