Fluorescent Kinetic Profiling Assay for High-Throughput Drug Discovery

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Solution Overview

Problem

Current methods for determining the kinetic profile of compounds in drug discovery are time-consuming, costly, and limited in throughput, often requiring radiolabeling and sophisticated equipment, which restricts the analysis to later stages of drug development and fails to provide comprehensive kinetic data for high-throughput screening.

Innovation Solution

A method that calculates the kinetic profile of compounds against target proteins or polyproteins using a competitive binding assay with fluorescent probes, allowing simultaneous measurement of affinity, association, and dissociation rates without pre-determining the inhibitor constant, enabling high-throughput screening and reducing the need for radiolabeling and complex equipment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If radioligand binding competition assays are used to determine kinetic profiles, then measurement precision is improved, but productivity deteriorates due to tedious and time-consuming procedures

Engineering Contradiction:
Improvekinetic profile measurement precisionVSAvoidthroughput of kinetic analysis
Core Design Contradiction:
Measurement precisionVSProductivity

Solution Approach 1:

The patent replaces the mechanical filtration and washing steps of radioligand assays with a homogeneous fluorescent-based detection system. The method uses fluorescently labeled ligands that allow direct measurement of binding kinetics without requiring physical separation of bound and free ligand, thereby eliminating tedious filtration steps while maintaining measurement precision.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent introduces fluorescently labeled ligands as intermediaries to mediate the detection of binding events. These fluorescent ligands serve as reporters that enable real-time monitoring of kinetic parameters through fluorescence intensity changes, replacing the need for radiolabeling and complex separation procedures while improving throughput.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Ease of operation

If sophisticated liquid handling systems with cherry-picking are used to automate kinetic assays, then ease of operation is improved, but device complexity increases

Engineering Contradiction:
Improveautomation of kinetic assayVSAvoidliquid handling system complexity
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The patent segments the kinetic assay into simple, discrete steps that can be performed in standard microplate formats. By dividing the assay into separate wells for different time points and using straightforward addition of reagents, the method enables automation with basic liquid handling equipment rather than requiring complex cherry-picking systems.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent uses identical assay conditions and reagent compositions across multiple wells and replicates, allowing standard liquid handling systems to simply dispense the same mixture into multiple locations. This eliminates the need for sophisticated systems that must handle varying volumes and compositions, as the assay design allows uniform treatment of all samples.

Inventive Principle:
Principle #26Copying

3Measurement precision

If pre-incubation at high ligand concentrations is performed to occupy binding sites, then measurement precision is improved, but loss of time increases due to multiple incubation steps

Engineering Contradiction:
Improvebinding site occupancy assuranceVSAvoidtotal assay time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The patent performs preliminary characterization of the fluorescent ligand's binding properties (Kd, kon, koff) in separate validation experiments. Once these parameters are established, the main kinetic assays can proceed with simplified protocols that do not require time-consuming pre-incubation steps, as the binding behavior is already known and can be accurately modeled.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent changes the detection parameter from measuring bound vs. free ligand separation to measuring fluorescence intensity changes directly. This parameter change allows the use of lower ligand concentrations and shorter incubation times, as the fluorescent signal provides real-time information about binding events without requiring complete site occupancy or multiple washing steps.

Inventive Principle:
Principle #35Parameter changes

4Measurement precision

If extensive washing steps are performed to separate bound from free radioligand, then measurement precision is improved, but loss of substance increases due to material loss during filtration

Engineering Contradiction:
Improveseparation of bound and free ligandVSAvoidligand loss during filtration
Core Design Contradiction:
Measurement precisionVSLoss of substance

Solution Approach 1:

The patent replaces the mechanical filtration and washing system with a homogeneous fluorescent detection system. By using fluorescently labeled ligands and measuring fluorescence intensity directly in the solution phase, the method eliminates the need for physical separation steps that cause material loss, thereby maintaining measurement precision without sacrificing ligand.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

This method simplifies the determination of kinetic profiles, reducing time and costs, and enables the analysis of multiple compounds in early drug discovery stages, providing comprehensive kinetic data for improved drug candidate selection and safety assessment.

Implementation Method 1

a first molecule having affinity for said target protein or polyprotein and labeled with a first fluorescent molecule

Methodology Applied
Scientific EffectFluorescence: Fluorescence

Implementation Method 2

wherein said first fluorescent molecule is an acceptor fluorophore and said second fluorescent molecule is a donor fluorophore

Methodology Applied
Scientific EffectFluorescence resonance energy transfer:

Data Source

PatentEP3350596B1Method for determining kinetic profiles in drug discovery
Publication Date: 2020.01.08 ENZYMLOGIC SL
  • EP3350596B1 patent drawingFigure 1
  • EP3350596B1 patent drawingFigure 2
  • EP3350596B1 patent drawingFigure 3

AI summary

The present invention relates to a reliable, robust and sensitive platform aimed to analyze the massive kinetic profile of new molecules against its main target and also against other potential targets. Thus, the present invention relates to a method for calculating the kinetic profile of a compound of interest against a target protein or polyprotein wherein it is not needed to predetermine the K, value of the compound of interest against the target protein or polyprotein before starting the assay. The present invention also discloses the use of said method in a high-throughput system for developing a Binding Kinetic Profiling assay of multiple compounds of interest against a unique target, or a Kinetic Selectivity Profiling assay of one selected compound against multiple target proteins or polyproteins to therefore establish multiple clinical profiles of potential drugs.