Stable anti-OSMR antibody formulation
Inventors
Manning, Mark Cornell • Shahrokh, Zahra • Nichols, Dave • Levesque, Philip M • Holcomb, Ryan Erik
Assignees
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Publication Number
US-11141479-B2
Publication Date
2021-10-12
Expiration Date
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.
Core Innovation
The invention relates to stable aqueous injectable formulations comprising an anti-oncostatin M receptor (OSMR) antibody. The formulations have a pH ranging from approximately 6.1-7.1 and contain arginine, histidine, and/or phosphate, together with an anti-OSMR antibody having a defined pI range and formulated at a high concentration.
A key aspect of the stable formulation is that the anti-OSMR antibody remains predominantly as monomer upon storage. The formulation is defined by monomer retention after storage and by limits on high molecular weight species/aggregates, together with maintenance of antigen-binding activity after storage or stress conditions.
The invention also specifies that the anti-OSMR antibody comprises defined heavy and light chain amino acid sequences and/or defined heavy-chain variable and light-chain variable domains, as set forth by SEQ ID NOs. The disclosed formulations further address injectability-related physical suitability for aqueous injection and include formulation suitability for freeze-thaw stability and multi-month storage, while maintaining the stability and quality constraints described above.
Claims Coverage
Two independent claims are provided. Both independent claims define stable aqueous anti-OSMR antibody formulations with pH and specified component ranges, and they further require quantitative stability/quality constraints and defined antibody sequence or pI characteristics.
Stable aqueous formulation with anti-OSMR antibody and controlled pH
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, and wherein the formulation is aqueous.
Monomer-stable anti-OSMR antibody with defined pI and concentration
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, wherein at least 90% of the anti-OSMR antibody exists as monomer in the formulation upon storage at 40°C for two weeks.
Defined anti-OSMR antibody sequences (SEQ ID NOs)
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.
Stable aqueous formulation with arginine, histidine, and NaCl at specified ranges
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.
Across the two independent claims, the inventive coverage centers on an aqueous, stable, high-concentration anti-OSMR antibody formulation with a defined pH, defined buffer/salt component ranges, and antibody characterization constraints. Claim 1 additionally requires monomer retention after storage and defined antibody sequences via SEQ ID NOs, while Claim 18 specifies the aqueous formulation composition ranges, including NaCl, and relies on pH and component selection, with dependent refinement relating to antibody pI.
Stated Advantages
Maintains the anti-OSMR antibody predominantly as monomer upon storage (at least 90% monomer after storage at 40°C for two weeks).
Provides stability characterized by limits and/or monitoring of high molecular weight species/aggregates and preservation of antigen-binding activity after storage or stress conditions.
Documented Applications
Subcutaneous treatment of OSMR-associated conditions, including pruritus.
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