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:
May. 08, 2018

Filed:

May. 11, 2017
Applicant:

Immunomedics, Inc., Morris Plains, NJ (US);

Inventors:

Li Zeng, Edison, NJ (US);

Rohini Mitra, Brigdewater, NJ (US);

Edmund A. Rossi, Woodland Park, NJ (US);

Hans J. Hansen, Picayune, MS (US);

David M. Goldenberg, Mendham, NJ (US);

Assignee:

Immunomedics, Inc., Morris Plains, NJ (US);

Attorney:
Primary Examiner:
Int. Cl.
CPC ...
C07K 16/30 (2006.01); C07K 16/28 (2006.01); A61K 51/08 (2006.01); A61K 51/10 (2006.01); A61K 39/00 (2006.01);
U.S. Cl.
CPC ...
C07K 16/3092 (2013.01); A61K 51/088 (2013.01); A61K 51/1027 (2013.01); A61K 51/1045 (2013.01); C07K 16/2803 (2013.01); C07K 16/2833 (2013.01); C07K 16/2887 (2013.01); C07K 16/30 (2013.01); C07K 16/3007 (2013.01); A61K 2039/505 (2013.01); A61K 2039/54 (2013.01); A61K 2039/545 (2013.01); A61K 2039/55505 (2013.01); A61K 2039/55511 (2013.01); C07K 2317/24 (2013.01); C07K 2317/31 (2013.01);
Abstract

Disclosed are methods, compositions and uses of high concentration antibody or immunoglobulin formulations for subcutaneous, intramuscular, transdermal or other local (regional) administration, in a volume of than 3, less than 2 or less than 1 ml. Preferably, the formulation contains a high concentration formulation (HCF) buffer comprising phosphate, citrate, polysorbate 80 and mannitol at a pH of about 5.2. The formulation more preferably comprises at least 100, 150, 200, 250 mg/ml or 300 mg/ml of antibody. The methods for preparing the high concentration formulation include ultrafiltration and diafiltration to concentrate the antibody and exchange the medium for HCF buffer. Other embodiments concern use of non-G1m1 (nG1m1) allotype antibodies, such as G1m3 and/or a nG1m1,2 antibodies. The nG1m1 antibodies show decreased immunogenicity compared to G1m1 antibodies.


Find Patent Forward Citations

Loading…