Antibodies to paliperidone and use thereof
Inventors
Hryhorenko, Eric • Sankaran, Banumathi • DeCory, Thomas R. • Tubbs, Theresa • Colt, Linda • Vliegen, Maarten • Haspeslagh, Pieter Rik
Assignees
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Publication Number
US-11385246-B2
Publication Date
2022-07-12
Expiration Date
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.
Core Innovation
The invention relates to isolated antibodies that specifically bind to paliperidone. The antibodies are defined by a light chain variable region comprising CDR1, CDR2 and CDR3 of SEQ ID NO:7 and a heavy chain variable region comprising CDR1, CDR2 and CDR3 of SEQ ID NO:8.
The invention further relates to methods for detecting paliperidone using labeled competitive immunoassays. In these competitive immunoassays, a sample is contacted with the isolated antibody and with paliperidone or a competitive binding partner of paliperidone, where one of the antibody and the paliperidone or the competitive binding partner is labeled with a detectable marker.
The invention also describes performing the immunoassay on a lateral flow assay device, including assay-kit/device components such as a capture zone, conjugate zone, and reaction zone. The description additionally supports multiplex detection on a single lateral flow strip, including aripiprazole, quetiapine, olanzapine, and risperidone/paliperidone.
Claims Coverage
The claims cover 3 inventive features: a specifically defined paliperidone-binding antibody, competitive immunoassay detection using a labeled detectable marker, and lateral flow assay device implementation.
Precisely defined paliperidone-binding antibody CDRs
An isolated antibody specifically binds paliperidone, with a light chain variable region comprising CDR1, CDR2 and CDR3 of SEQ ID NO:7 and a heavy chain variable region comprising CDR1, CDR2 and CDR3 of SEQ ID NO:8.
Competitive immunoassay with labeled detectable marker
A competitive immunoassay for detecting paliperidone in a sample by contacting the sample with the antibody and with paliperidone or a competitive binding partner of paliperidone, wherein one of the antibody and the paliperidone or the competitive binding partner is labeled with a detectable marker; detecting the amount of the detectable marker detects sample paliperidone.
Lateral flow assay device implementation
Performing the immunoassay on a lateral flow assay device, including assay-kit/device components such as a capture zone, conjugate zone, and reaction zone.
Overall, the claim set is anchored on a specifically defined isolated paliperidone-binding antibody and extends to competitive immunoassay detection with a labeled detectable marker and lateral flow assay device implementation.
Stated Advantages
Supports therapeutic drug monitoring and adherence support using immunoassay detection.
Enables multiplex detection on a single lateral flow strip for aripiprazole, quetiapine, olanzapine, and risperidone/paliperidone.
Reports orthogonality and binding restricted to the intended reaction zone in lateral flow multiplex performance.
Shows competitive ELISA cross-reactivity in Example 5.
Documented Applications
Therapeutic drug monitoring and adherence support using labeled competitive immunoassays for detecting paliperidone.
Point-of-care detection using lateral flow assay devices.
Multiplex point-of-care detection for aripiprazole, quetiapine, olanzapine, and risperidone/paliperidone on a single lateral flow strip.
Competitive ELISA cross-reactivity testing for antibody binding specificity [documented in Example 5].
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