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Method and system for detecting antibodies by surface plasmon resonance

A surface plasmon and antibody technology, applied in the direction of material analysis, measuring devices, instruments, etc. through optical means, can solve the problems of time-consuming accuracy and expensive testing methods

Pending Publication Date: 2022-05-27
LAB OF AMERICA HLDG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, current testing methods are expensive, time-consuming and have questionable accuracy

Method used

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  • Method and system for detecting antibodies by surface plasmon resonance
  • Method and system for detecting antibodies by surface plasmon resonance
  • Method and system for detecting antibodies by surface plasmon resonance

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0103] Example 1 - Intra- and inter-assay accuracy and imprecision

[0104]Certolizumab PEG by Surface Plasmon Resonance Assay is a ligand-binding assay for the detection of certolizumab PEG in human serum. Certolizumab PEG is a drug that is a PEGylated Fab' fragment of a monoclonal antibody specific for tumor necrosis factor alpha (TNFα).

[0105] Anti-TNFα was covalently immobilized on the SPR biosensor. TNFα then flows through the biosensor as a capture molecule for certolizumab polyethylene glycol in standards, controls, and patient samples. Next, the standard, control, or unknown is diluted in phosphate buffer and filtered. The diluted standard, control, or unknown is then flowed through the biosensor. Finally, an antibody against certolizumab polyethylene glycol was flowed through the biosensor to enhance the final signal obtained from SPR. The final enhanced signal was measured and the certolizumab polyethylene glycol concentration in each unknown sample and contr...

Embodiment 2

[0122] Example 2 - Selectivity and Specificity

[0123] The following potential interferers (ie compounds or biomolecules that may interfere with antibody measurements) were added to human serum containing certolizumab polyethylene glycol at low and moderate target levels: adalimumab, golimumab, Infliximab, and rituximab (and, if any, other drugs of similar nature) were analyzed at the therapeutic level. Samples containing interferents were tested in a single batch in triplicate.

[0124] selective

[0125] To determine whether other similar drugs interfere with the current detection platform, samples containing certolizumab polyethylene glycol and interfering substances were analyzed. Samples were analyzed at low and moderate levels of certolizumab polyethylene glycol concentrations, and interfering substances were analyzed at therapeutic concentrations.

[0126] All samples were analyzed in triplicate and average recoveries were based on certolizumab polyethylene glyc...

Embodiment 3

[0141] Example 3 - Examples of Certain Embodiments

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Abstract

The present disclosure relates to methods for detecting antibodies or antibody fragments in a biological sample from a subject. In some embodiments, the method includes immobilizing a first binding agent on a surface plasmon resonance (SPR) biosensor; adding a ligand bound to the first binding agent under conditions such that a complex of the ligand and the first binding agent is formed; adding an aliquot of the biological sample under conditions such that the antibody and / or the antibody fragment binds to the ligand complexed with the first binding agent; and detecting the presence of the antibody and / or antibody fragment as a change in the signal obtained from the SPR. In some embodiments, the antibody is an antibody therapeutic agent, such as setuzumab polyethylene glycol. Systems and kits for detecting antibodies in a biological sample from a subject using SPR are also disclosed.

Description

[0001] previous related applications [0002] This application claims priority to US Provisional Patent Application No. 62 / 834,649, filed April 16, 2019, the contents of which are incorporated herein by reference in their entirety. Background technique [0003] Therapeutic antibodies are becoming a more common approach to treating conditions such as cancer and autoimmune diseases. However, while one patient may benefit from treatment with a therapeutic antibody, another patient may not respond to treatment or find that treatment becomes less effective over time. This may be due to both suboptimal dosing and / or premature clearance of therapeutic antibodies by antidrug antibodies. Optimizing a patient's dose requires measuring the concentration of the therapeutic antibody in the patient's blood. However, current testing methods are expensive, time-consuming and have questionable accuracy. [0004] SUMMARY OF THE INVENTION [0005] The present disclosure relates to methods fo...

Claims

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Application Information

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IPC IPC(8): G01N33/543
CPCG01N33/54306G01N33/54373G01N33/543G01N33/54353G01N33/548G01N33/553G01N33/6854G01N21/553
Inventor M·K·M·凯利门B·霍姆奎斯特
Owner LAB OF AMERICA HLDG