# US 10,370,457 B2 · Antibodies to paliperidone haptens and use thereof

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- Number: US 10,370,457 B2
- Document ID: US10370457B2
- Status: Granted
- Kind: B2
- Application number: 15/410,425
- Filed: 2017-01-19
- Published: 2017-05-11
- Granted: 2019-08-06
- Earliest claimed: 2012-08-21
- Assignees: Janssen Pharmaceutica NV
- Applicants: Janssen Pharmaceutica NV
- Inventors: Eric Hryhorenko; Banumathi Sankaran; Thomas R. DeCory; Theresa Tubbs; Linda Colt; Maarten Vliegen; Pieter Rik Haspeslagh
- Web page: https://patentgrep.com/patent/US10370457B2

## CPC

- C07K 16/44: against material not provided for elsewhere {, e.g. haptens, metals, DNA, RNA, amino acids}
- A61P 25/18: Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
- A61P 25/24: Antidepressants
- G01N 33/94: involving narcotics {or drugs or pharmaceuticals, neurotransmitters or associated receptors}
- G01N 33/9406: {Neurotransmitters}
- C07K 2317/14: Specific host cells or culture conditions, e.g. components, pH or temperature
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## 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, olanzapine, quetiapine, risperidone and paliperidone in a single lateral flow assay device.

## Claims

### Claim 1

A method of producing an antibody or a binding fragment thereof which binds to paliperidone, the method comprising:
(i) selecting a host for antibody production; and
(ii) inoculating the host with a conjugate of a compound of Formula I and an immunogenic carrier, wherein the host produces an antibody which binds to paliperidone,
wherein
L1 is OC(O)(CH2)n, or O(CH2)n;
wherein n is 2 or 3;
L2 is NHC(O),
or absent;
L3 is (CH2)mCO2H, or
wherein m is 0, 1, 2, or 3; provided that m may only be 0 if L2 is absent, and further provided that when L2 is absent L3 is

### Claim 2

A method of producing a hybridoma cell line capable of producing a monoclonal antibody which binds to paliperidone, the method comprising:
(i) selecting a host for antibody production;
(ii) inoculating the host with a conjugate of a compound of Formula I and an immunogenic carrier;
(iii) fusing a cell line from said inoculated host with a continuously dividing cell to create a fused cell capable of producing a monoclonal antibody which binds to paliperidone; and
(iv) cloning the fused cell so as to obtain a hybridoma cell line,
wherein
L1 is OC(O)(CH2)n, or O(CH2)n;
wherein n is 2 or 3;
L2 is NHC(O),
or absent;
L3 is (CH2)mCO2H, or
wherein m is 0, 1, 2, 3; provided that m may only be 0 if L2 is absent, and further provided that when L2 is absent L3 is

### Claim 3 (depends on 1)

The method of claim 1, wherein the immunogenic carrier is a protein.

### Claim 4 (depends on 3)

The method of claim 3, wherein the protein is keyhole limpet hemocyanin, bovine thyroglobulin, or ovalbumin.

### Claim 5 (depends on 2)

The method of claim 2, wherein the immunogenic carrier is a protein.

### Claim 6 (depends on 5)

The method of claim 5, wherein the protein is keyhole limpet hemocyanin, bovine thyroglobulin, or ovalbumin.

### Claim 7 (depends on 1)

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

### Claim 8 (depends on 1)

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