Stabilized liquid formulations containing receptors

Patent metadata

Field	Value
Publication number	US-10203338-B2
Application number	US-201414891269-A
Country	US
Kind code	B2
Filing date	May 13, 2014
Priority date	May 14, 2013
Publication date	Feb 12, 2019
Grant date	Feb 12, 2019

Abstract

Methods and reagents are disclosed for preparing a liquid solution of a receptor. The methods comprise combining in a liquid medium the receptor, a chelating agent and a C2-C6 polyol. An amount of the chelating agent and the C2-C6 polyol is sufficient to achieve a stable and active receptor in the liquid solution, which is maintained at a temperature of about 2° C. to about 40° C. The compositions may be employed in assays for the determination of analytes that include receptor-binding analytes.

First claim

What is claimed is:

1. A method of stabilizing a liquid solution of a thyroid stimulating hormone receptor, the method comprising:
combining a liquid solution comprising a thyroid stimulating hormone receptor with a stabilizing amount of both (i) a chelating agent selected from the group consisting of triacetic acid chelating agents and tetraacetic acid chelating agents and (ii) a C3-05 polyol,
wherein the stabilizing amount of the chelating agent is about 0.1 mM to about 2 mM and the stabilizing amount of the C3-05 polyol is about 20% to about 50% by weight, the stabilized liquid solution of the thyroid stimulating hormone receptor having a half-life of at least about 20 months during storage at a temperature of about 2° C. to about 40° C.

2. The method according to claim 1 wherein the thyroid-stimulating hormone receptor is a thyroid stimulating hormone receptor chimera bound to a support or a label.

3. The method according to claim 1 wherein the chelating agent is selected from the group consisting of N-(2-hydroxyethyl)-ethylenediamine-N,N′,N′-triacetic acid and its salts, ethylene diamine tetraacetic acid and its salts, and ethylene glycol tetraacetic acid and its salts.

4. The method according to claim 1 wherein the stabilizing amount of chelating agent in the liquid solution is about 1 mM, and wherein the stabilized liquid solution of the thyroid stimulating hormone receptor retains at least about 60% of an initial receptor signal after 2 days of storage at 37° C.

5. The method according to claim 1 wherein the stabilizing amount of C3-05 polyol is about 30% to about 50% by weight, and wherein the stabilized liquid solution of the thyroid stimulating hormone receptor retains about 100% of an initial receptor signal after 7 days of storage at 37° C.

Assignees

• Siemens Healthcare Diagnostics Inc

Inventors

• Kiaei David

Classifications

• G01N2333/726

  G protein coupled receptor, e.g. TSHR-thyrotropin-receptor, LH/hCG receptor, FSH · CPC title

• C07K14/723 Primary

  G protein coupled receptor, e.g. TSHR-thyrotropin-receptor, LH/hCG receptor, FSH receptor · CPC title

• G01N33/5306

  Improving reaction conditions, e.g. reduction of non-specific binding, promotion of specific binding · CPC title

• G01N33/6854 Primary

  Immunoglobulins · CPC title

• G01N33/78

  Thyroid gland hormones {, e.g. T3, T4, TBH, TBG or their receptors} · CPC title