Proximity Assay for Factor D Activity Measurement

Resolve Bottlenecks,
Find Innovative Solutions
Generate Solutions

Solution Overview

Problem

Current methods for measuring Factor D activity and determining the potency of Factor D inhibitors are complex, time-consuming, and not adaptable to high-throughput assays, limiting their effectiveness in diagnosing disorders and assessing therapeutic efficacy.

Innovation Solution

A proximity-based measurement assay that measures the cleavage of Factor B using labeled antibodies and moieties, allowing for simple, fast, and homogeneous analysis of Factor D activity and inhibitor potency, which can be scaled for high-throughput screening.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If traditional methods for measuring Factor D activity are used, then measurement can be performed, but the process becomes complex and time-consuming

Engineering Contradiction:
ImproveFactor D activity measurementVSAvoidassay complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The assay is segmented into distinct functional components: Factor B substrate with C3b binding domain, detection antibodies specific to Factor B cleavage products, and signal generation system. This segmentation allows each component to be optimized independently while simplifying the overall measurement process.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Detection antibodies serve as intermediaries that bridge the enzymatic cleavage event and the measurable signal. These antibodies specifically bind to cleavage products and generate detectable signals, simplifying the measurement process while maintaining precision.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Measurement precision

If traditional methods for measuring Factor D activity are used, then measurement can be performed, but the process is time-consuming

Engineering Contradiction:
ImproveFactor D activity measurementVSAvoidassay time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

Factor B is pre-incubated with C3b binding domain and detection antibodies before adding Factor D enzyme. This preliminary setup allows the assay to proceed directly to measurement upon enzyme addition, reducing total assay time while maintaining measurement precision.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The assay is designed as a continuous homogeneous reaction where Factor D continuously cleaves Factor B and detection antibodies continuously generate signals. This eliminates stopping and starting steps, reducing assay time while maintaining precision through continuous measurement.

Inventive Principle:
Principle #20Continuity of useful action

3Measurement precision

If traditional methods for measuring Factor D activity are used, then measurement can be performed, but they are not adaptable to high-throughput assays

Engineering Contradiction:
ImproveFactor D activity measurementVSAvoidhigh-throughput adaptability
Core Design Contradiction:
Measurement precisionVSAdaptability or versatility

Solution Approach 1:

The assay components are designed with universal characteristics: Factor B substrate can be used with different detection antibodies, and the signal generation system is compatible with multiple detection platforms. This universality enables the same basic assay to be adapted to high-throughput formats while maintaining measurement precision.

Inventive Principle:
Principle #6Universality (Multi-functionality)

Solution Approach 2:

The assay parameters such as component concentrations, incubation times, and signal detection settings can be adjusted to optimize for high-throughput formats. This flexibility allows the same assay design to maintain precision across different throughput levels.

Inventive Principle:
Principle #35Parameter changes

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

The method provides precise and efficient measurement of Factor D activity and inhibitor potency, facilitating diagnostics and therapeutic assessment, and enabling rapid screening of Factor D inhibitors.

Implementation Method 1

measuring the cleavage of Factor B using a proximity-based measurement assay

Methodology Applied
Scientific EffectProximity-based measurement:

Data Source

PatentEP3368682B1Methods of measuring factor d activity and potency of factor d inhibitors
Publication Date: 2019.12.11 F HOFFMANN LA ROCHE & CO AG
  • EP3368682B1 patent drawingFigure 1
  • EP3368682B1 patent drawingFigure 2
  • EP3368682B1 patent drawingFigure 3

AI summary

The invention relates to methods of measuring the activity of Factor D, the key driver in the activation of the alternative complement pathway, methods of determining the potency of Factor D inhibitors, and methods of screening for Factor D inhibitors.