Antibodies to paliperidone and use thereof

Patent metadata

Field	Value
Publication number	US-10379129-B2
Application number	US-201615287301-A
Country	US
Kind code	B2
Filing date	Oct 6, 2016
Priority date	Aug 21, 2012
Publication date	Aug 13, 2019
Grant date	Aug 13, 2019

Abstract

Disclosed is an antibody which binds to paliperidone, which can be used to detect paliperidone in a sample such as in a competitive immunoassay method. The antibody can be used in a lateral flow assay device for point-of-care detection of paliperidone, including multiplex detection of aripiprazole, quetiapine, olanzapine, and risperidone/paliperidone in a single lateral flow assay device.

First claim

What is claimed is:

1. An isolated antibody or a binding fragment thereof, which specifically binds to paliperidone comprising a light chain variable region comprising CDR1, CDR2 and CDR3 of SEQ ID NO:3, and a heavy chain variable region comprising CDR1, CDR2 and CDR3 of SEQ ID NO:4, wherein the light chain CDR1 sequence comprises amino acid residues 44 to 60 of SEQ ID NO:3; the light chain CDR2 sequence comprises amino acid residues 76 to 82 of SEQ ID NO:3; the light chain CDR3 sequence comprises amino acid residues 115 to 123 of SEQ ID NO:3; the heavy chain CDR1 sequence comprises amino acid residues 45 to 54 of SEQ ID NO:4; the heavy chain CDR2 sequence comprises amino acid residues 69 to 85 of SEQ ID NO:4; and the heavy chain CDR3 sequence comprises amino acid residues 118 to 122 of SEQ ID NO:4.

2. The isolated antibody or a binding fragment thereof of claim 1 , wherein the antibody fragment is selected from the group of fragments consisting of Fv, F(ab′), F(ab′)2, scFv, minibody and diabody fragments.

3. The isolated antibody of claim 1 , wherein the antibody is a monoclonal antibody.

4. An assay kit comprising the isolated antibody or a binding fragment thereof of claim 1 .

5. An assay device comprising the isolated antibody or a binding fragment thereof of claim 1 .

6. The assay device of claim 5 , wherein the device is a lateral flow assay device.

7. A method of detecting paliperidone in a sample, the method comprising:
(i) contacting a sample with the antibody or binding fragment thereof of claim 1 labeled with a detectable marker, wherein the labeled antibody or a binding fragment thereof and paliperidone present in the sample form a labeled complex; and
(ii) detecting the labeled complex, thereby detecting paliperidone in the sample.

8. A competitive immunoassay method for detecting paliperidone in a sample, the method comprising:
(i) contacting a sample with the antibody or binding fragment thereof of claim 1 , and with paliperidone or a competitive binding partner of paliperidone, wherein one of the antibody or binding fragment thereof and the paliperidone or competitive binding partner thereof is labeled with a detectable marker, and wherein sample paliperidone competes with the paliperidone or competitive binding partner thereof for binding the antibody or binding fragment thereof to form a complex; and
(ii) detecting the amount of label to detect sample paliperidone.

9. The method of claim 8 , wherein the paliperidone or competitive binding partner thereof is labeled with the detectable marker.

10. The method of claim 8 , wherein the antibody or binding fragment thereof is labeled with a detectable marker.

11. The method of claim 8 , wherein the immunoassay is performed on a lateral flow assay device and the sample is applied to the device.

Assignees

• Janssen Pharmaceutica Nv

Inventors

• Hryhorenko Eric
• Sankaran Banumathi
• Decory Thomas R
• Tubbs Theresa
• Colt Linda
• Vliegen Maarten
• Haspeslagh Pieter Rik

Classifications

• G01N33/9406

  Neurotransmitters · CPC title

• C07K2317/33

  Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity · CPC title

• C07K2317/56

  variable (Fv) region, i.e. VH and/or VL · CPC title

• G01N33/9413 Primary

  Dopamine · CPC title

• C07K16/44

  against material not provided for elsewhere {, e.g. haptens, metals, DNA, RNA, amino acids} · CPC title