Stable anti-OSMR antibody formulation
AssigneeKiniksa Pharmaceuticals, GmbH
InventorsMark Cornell Manning, Zahra Shahrokh, Dave Nichols, Philip M Levesque, Ryan Erik Holcomb
Life of this patent
Estimating the term…
Abstract
The present invention provides, among other things, stable formulations comprising an anti-oncostatin M receptor (OSMR) antibody and having a pH ranging from approximately 6.0-7.6, wherein less than approximately 5% of the anti-OSMR antibody exists as high molecular weight (HMW) species in the formulation.
Claims19
A stable formulation comprising an anti-oncostatin M receptor (OSMR) antibody and having a pH ranging from approximately 6.1-7.1,
- wherein the formulation comprises 10-150 mM arginine, 10-20 mM histidine, or 5-75 mM phosphate,
- wherein the anti-OSMR antibody has a pI ranging from 6.5-8.0 and is present in the formulation at a concentration ranging from 100-250 mg/ml, and
- wherein at least 90% of the anti-OSMR antibody exists as monomer in the formulation upon storage at 40° C. for two weeks;
- and
- wherein the anti-OSMR antibody comprises (i) a heavy chain having the amino acid sequence set forth in SEQ ID NO:
- 1;
- and a light chain having the amino acid sequence set forth in SEQ ID NO:
- 2;
- or (ii) a heavy chain variable domain having the amino acid sequence set forth in SEQ ID NO:
- 3;
- and a light chain variable domain having the amino acid sequence set forth in SEQ ID NO:
- 4,
- wherein the formulation is aqueous.
A stable formulation comprising an anti-oncostatin M receptor (OSMR) antibody, wherein the formulation has a pH in a range of 6.1-7.1 and comprises
- 100-250 mg/ml of the anti-OSMR antibody
- 10-150 mM arginine,
- 10-20 mM histidine, and
- 25-250 mM NaCl,
- wherein the formulation is aqueous.
Dependencies are inferred from the claim text.