High Concentration Liquid Antibody Formulations
The present disclosure describes high concentration liquid formulations of a pharmaceutically active antigen binding protein, for example a monoclonal antibody. Such formulations comprise, in addition to the antigen binding protein, at least 80 mM of a buffering agent and at least 80 mM of a stabilizer. In addition, the present disclosure is related to pharmaceutical formulations of an anti-IL-17C antibody and provides methods of making and methods of using such formulations.
1 . A pharmaceutical formulation for an antigen binding protein comprising:
a) about 100 to 250 mg/mL antigen binding protein;
b) about 80 to 100 mM of a buffering agent providing a pH of about 5.0 to about 7.0; and
c) about 80 to 100 mM of a stabilizer.
2 . A pharmaceutical formulation according to claim 1 wherein the buffering agent is a histidine buffer and wherein the stabilizer is an amino acid.
3 . The pharmaceutical formulation according claim 2 , wherein the histidine buffer concentration is about 100 mM.
4 . The pharmaceutical formulation according to claim 3 , wherein the histidine buffer concentration is 100 mM.
5 . The pharmaceutical formulation according to any claim 2 , wherein the histidine buffer is histidine hydrochloride and wherein the amino acid is arginine.
6 . The pharmaceutical formulation according to claim 5 , wherein the arginine concentration is about 100 mM.
7 . The pharmaceutical formulation according to claim 6 , wherein the arginine concentration is 100 mM.
8 . The pharmaceutical formulation according to any claim 1 , further comprising about 0.005 to 0.05% (w/v) of a nonionic surfactant.
9 . The pharmaceutical formulation according to claim 8 , wherein the nonionic surfactant is polysorbate 20 or polysorbate 80.
10 . The pharmaceutical formulation according to claim 9 , wherein the polysorbate 20 or polysorbate 80 concentration is 0.02% (w/v).
11 . The pharmaceutical formulation according to claim 1 , wherein the buffering agent provides a pH of 6.0±0.2.
12 . The pharmaceutical formulation according to any claim 1 for subcutaneous or intramuscular administration.
13 . The pharmaceutical formulation according to claim 1 , wherein said antigen binding protein has a self-interaction propensity.
14 . The pharmaceutical formulation according to claim 1 , wherein said antigen binding protein is a monoclonal antibody or antibody fragment thereof.
15 . The pharmaceutical formulation according to claim 14 , wherein said monoclonal antibody or antibody fragment thereof specifically binds to human IL-17C (SEQ ID NO: 1).
16 . The pharmaceutical formulation according to claim 15 , wherein said monoclonal antibody or antibody fragment thereof comprises heavy and light chain variable regions comprising amino acid sequences that are 90% identical to SEQ ID NOs: 16 and 17 respectively.
17 . The pharmaceutical formulation according to claim 16 , wherein said monoclonal antibody or antibody fragment thereof comprises heavy and light chain variable regions comprising amino acid sequences according to SEQ ID NOs: 16 and 17, respectively.
18 . An injection device comprising a pharmaceutical formulation according to claim 1 .