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Potency assays for antibody drug substance binding to FC receptor

A technology of receptor binding and receptors, which is applied in the direction of antibodies, measuring devices, instruments, etc., can solve the problems that bioassays are not methods for assay batch release

Inactive Publication Date: 2008-09-17
GENMAB AS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

These bioassays are therefore not the most preferred method for assaying lot release

Method used

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  • Potency assays for antibody drug substance binding to FC receptor
  • Potency assays for antibody drug substance binding to FC receptor
  • Potency assays for antibody drug substance binding to FC receptor

Examples

Experimental program
Comparison scheme
Effect test

Embodiment approach 1

[0257] Embodiment 1 A method for determining the drug efficacy of a drug containing an FcR-binding peptide, wherein at least one mechanism of action of the drug's FcR-binding peptide is mediated by the binding of the drug's FcR-binding peptide to an Fc receptor, wherein the method includes determining the drug's FcR-binding Binding of peptides to Fc receptors.

Embodiment approach 2

[0258] Embodiment 2 The method according to Embodiment 1 for determining the efficacy of a drug containing an FcR-binding peptide comprises

[0259] i) Determination of the binding of the reference standard FcR-binding peptide to the Fc receptor

[0260] ii) Determining the binding of the pharmaceutical FcR-binding peptide to the aforementioned Fc receptors

[0261] iii) comparing the binding status of the FcR in step ii) with the FcR in step i), and using the information obtained from the comparison to evaluate the efficacy of the drug.

[0262] in

[0263] a) The determination method of Fc receptor binding in step ii) is the same as the determination method of Fc receptor binding in step i).

[0264] b) At least one mechanism of action of the pharmaceutical FcR-binding peptide is mediated by the binding of the FcR-binding peptide to an Fc receptor.

[0265] c) wherein the reference standard FcR-binding peptide and the pharmaceutical FcR-binding peptide are two preparation...

Embodiment approach 3 1

[0266] Embodiment 3 A method of producing a pharmaceutical composition comprising an FcR-binding peptide, the method comprising

[0267] a) the medicinal product contains said FcR-binding peptide;

[0268] b) applying the method of embodiment 1 or embodiment 2 to the drug to determine the efficacy of the drug containing the FcR-binding peptide;

[0269] c) Using the information obtained in step b) as part of the basis for evaluating whether the drug can be used as a pharmaceutical composition.

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Abstract

The invention relates to a method of characterizing an antibody, which method is suitable as a potency assay for batch release of a pharmaceutical composition comprising an antibody, specifically for use when applying for marketing authorization for said pharmaceutical composition. The assay provided is a method for determining the potency of a drug product comprising an FcR binding peptide, wherein at least one mechanism of action of the FcR binding peptide of the drug product is mediated through the binding of the FcR binding peptide of the drug product to a Fc receptor, wherein said method comprises determining the binding of the FcR binding peptide of the drug product to an Fc receptor.

Description

field of invention [0001] The invention relates to a method for identifying an antibody, which is suitable for use as a method for determining the drug efficacy of a batch release of a pharmaceutical composition containing the antibody, and is especially suitable for applying for marketing authorization of the above-mentioned drugs. Background of the invention [0002] When producing a pharmaceutical composition, it is not enough to make the drug substance into a drug product, and it is also important to obtain approval from the drug regulatory agency of the country where the pharmaceutical composition is used. The US regulatory agency is the US Food and Drug Administration (FDA) (http: / / www.fda.gov / ). Europe such as the European Medicines Agency (EMEA) ( http: / / www.emea.eu.int / ). [0003] The review process is tightly controlled, and regulators require drug developers to submit extensive drug-related information in order to obtain approval. This may include information ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/566A61K39/395
Inventor C・E・G・哈夫尼思T・文克P・范伯克尔P・帕伦
Owner GENMAB AS
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