Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-11630111-B2
Publication Date
2023-04-18
Expiration Date
Abstract
The present invention relates to a method for quantifying an anti-TNF antibody in a sample of a human individual comprising a step of adding to a test sample which may contain therapeutic anti-TNF antibodies a known amount of two or more labeled forms of said anti-TNF antibodies.
Core Innovation
The patent describes LC-MS/MS (MRM/SRM) quantification of therapeutic anti-TNF antibodies in human plasma/serum. Stable isotopically labeled whole anti-TNF antibodies are used as internal standards, selected from Infliximab, Etanercept, Adalimumab, Certolizumab, and Golimumab. Two or more stable isotopically labeled whole anti-TNF antibodies are introduced into the sample, enabling measurement of proteolysis peptide surrogates associated with the corresponding unlabeled antibodies.
The approach measures ratios between stable isotopically labeled and corresponding unlabeled proteolysis peptides after proteolysis. Proteolysis is performed using trypsin and/or a hinge-targeting protease, and surrogate peptide selections are provided to support peptide measurement for different antibodies. The measured labeled-to-unlabeled ratios are converted to concentrations using calibration curves.
The disclosure further includes optional IgG enrichment/immunocapture, and describes SRM/MRM transition setup on a triple quadrupole mass spectrometer. The patent also describes kit concepts comprising stable isotopically labeled anti-TNF antibodies plus reagents such as a protease, together with calibration information. Examples described include multiplex reverse titration and antigen-capture saturation assessment.
Claims Coverage
The provided material identifies one independent claim. The independent claim centers on a kit concept that uses two or more whole stable isotopically labeled anti-TNF antibodies as internal standards.
A kit for quantifying anti-TNF antibodies using whole SIL antibodies
A kit for quantifying anti-TNF antibodies comprising two or more stable isotopically labeled anti-TNF antibodies selected from Infliximab, Etanercept, Adalimumab, Certolizumab and Golimumab, wherein the two or more stable isotopically labeled anti-TNF antibodies are whole antibodies.
Across the provided independent claim coverage, the core inventive aspect is a quantification kit that relies on two or more whole stable isotopically labeled anti-TNF antibodies from the specified set, forming the basis for subsequent proteolysis-peptide measurement and calibration.
Stated Advantages
Allows quantifying therapeutic anti-TNF antibodies in human plasma/serum using LC-MS/MS (MRM/SRM) with stable isotopically labeled whole anti-TNF antibodies as internal standards.
Documented Applications
Therapeutic drug monitoring / pharmacokinetic-type quantification of therapeutic anti-TNF antibodies in human plasma/serum.
Multiplex reverse titration and antigen-capture saturation assessment.
Interested in licensing this patent?