Risk assessment for therapeutic drugs
First Claim
1. A method for assessing risks associated with human immune responses against therapeutic drugs, the method comprising:
- a. Contacting a biological sample from a human subject with a portable device capable of testing for human anti-drug antibodies (ADAs) against one or more therapeutic drugs, wherein labeled entities are immobilized on the portable device, wherein said labeled entities on said device can bind to a constant region of the human ADAs and wherein the labeled entities bound to ADAs complex flow towards to one or more capture reagent immobilized on the device, and wherein the capture reagent comprises said therapeutic drugs or regions of said therapeutic drugs;
b. Detecting a visible signal resulting from binding of ADAs from step (a) to one or more therapeutic drugs or regions of said therapeutic drugs immobilized on the device; and
c. Correlating signal from step (b) with presence or absence of ADAs.
1 Assignment
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Accused Products
Abstract
Methods to estimate safety and/or efficacy of therapeutic drugs, which include portable devices for anti-drug antibody (ADA) testing and databases containing anonymized data from humans and/or animal models, and related analyses, are provided. These methods and compositions can be used in various applications, including but not restricted to the following: uniform testing of patients for ADA; selection of therapeutic drug for patient treatment; evaluation of the need to change therapeutic drug or to apply tolerance regimens; selection of patients for clinical trials; comparison of therapeutic drugs marketed for a given disease and also gene therapy; scientific guidance for discovering and/or developing therapeutic drugs; postmarketing surveillance of therapeutic drugs.
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Citations
11 Claims
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1. A method for assessing risks associated with human immune responses against therapeutic drugs, the method comprising:
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a. Contacting a biological sample from a human subject with a portable device capable of testing for human anti-drug antibodies (ADAs) against one or more therapeutic drugs, wherein labeled entities are immobilized on the portable device, wherein said labeled entities on said device can bind to a constant region of the human ADAs and wherein the labeled entities bound to ADAs complex flow towards to one or more capture reagent immobilized on the device, and wherein the capture reagent comprises said therapeutic drugs or regions of said therapeutic drugs; b. Detecting a visible signal resulting from binding of ADAs from step (a) to one or more therapeutic drugs or regions of said therapeutic drugs immobilized on the device; and c. Correlating signal from step (b) with presence or absence of ADAs. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
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Specification