US 12,296,007 B2
High concentration anti-blys pharmaceutical formulations
Angela Blake-Haskins, Gaithersburg, MD (US); Tristan Marshall, Gaithersburg, MD (US); Melissa D. Perkins, McPherson, KS (US); and Kristin O'Berry, Gaithersburg, MD (US)
Assigned to GlaxoSmithKline Intellectual Property Management Limited, Stevenage (GB)
Filed by GlaxoSmithKline Intellectual Property Management Limited, Stevenage (GB)
Filed on Nov. 5, 2021, as Appl. No. 17/519,606.
Application 17/519,606 is a continuation of application No. 16/736,042, filed on Jan. 7, 2020, granted, now 11,179,463.
Application 16/736,042 is a continuation of application No. 15/311,223, granted, now 10,556,009, previously published as PCT/IB2015/053602, filed on May 15, 2015.
Claims priority of provisional application 62/095,181, filed on Dec. 22, 2014.
Claims priority of provisional application 62/093,734, filed on Dec. 18, 2014.
Claims priority of provisional application 61/994,427, filed on May 16, 2014.
Prior Publication US 2022/0175922 A1, Jun. 9, 2022
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 39/395 (2006.01); A61K 39/00 (2006.01); C07K 16/24 (2006.01); C07K 16/28 (2006.01)
CPC A61K 39/39591 (2013.01) [C07K 16/244 (2013.01); C07K 16/2875 (2013.01); A61K 2039/505 (2013.01); C07K 2317/21 (2013.01); C07K 2317/41 (2013.01)] 16 Claims
 
1. A pharmaceutical formulation for an antigen binding protein comprising:
a. 200±20 mg/ml of the antigen binding protein;
b. about 1 to 100 mM of a buffering agent providing a pH of about 5.0 to about 7.0, wherein the buffering agent is histidine; and
c. about 70 to 170 mM of a tonicity agent, wherein the tonicity agent is sodium chloride;
wherein the antigen binding protein is a monoclonal antibody or fragment thereof comprising amino acid sequences CDRH1 of SEQ ID NO: 11, CDRH2 of SEQ ID NO: 12, CDRH3 of SEQ ID NO: 13, CDRL1 of SEQ ID NO: 14, CDRL2 of SEQ ID NO: 15, and CDRL3 of SEQ ID NO: 16; and
wherein the pharmaceutical formulation is suitable for subcutaneous administration.