Platelet Aggregation Assay for Anti-CD40L Clotting Risk

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Solution Overview

Problem

The role of the CD40/CD40L pathway in regulating coagulation at the level of platelet/endothelial cell interaction is undefined, and thromboembolic complications have been observed in clinical trials of anti-CD40L antibodies, necessitating a method to determine susceptibility to clotting upon administration.

Innovation Solution

In vitro methods involving platelet activation with agents like ADP, followed by contact with an anti-CD40L antibody and a cross-linking agent, with platelet aggregation quantified by sedimentation, to assess susceptibility to clotting, using kits that include these agents and instructions.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If anti-CD40L antibody is administered to treat autoimmune disorders, then therapeutic effect is improved, but thromboembolic complications increase

Engineering Contradiction:
Improvetherapeutic effectVSAvoidthromboembolic complications
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent performs platelet aggregation assays before administering anti-CD40L antibody to identify patients at risk for thromboembolic complications. This preliminary screening allows clinicians to select appropriate candidates for therapy, preventing harmful effects before they occur by excluding high-risk individuals from receiving the antibody treatment.

Inventive Principle:
Principle #10Preliminary action

2Reliability

If platelet aggregation is measured to assess clotting susceptibility, then patient safety is improved, but assay complexity increases

Engineering Contradiction:
Improvepatient safety assessmentVSAvoidassay complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The assay is divided into distinct sequential steps: (1) activation of platelets with agonists, (2) addition of anti-CD40L antibody, and (3) measurement of aggregation. This segmentation into manageable stages simplifies the overall complex process, making it easier to perform and interpret while maintaining accurate safety assessment.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent uses anti-CD40L antibody as an intermediary agent in the assay to specifically probe the CD40/CD40L pathway's role in platelet aggregation. This intermediary allows selective measurement of pathway-specific aggregation mechanisms, enabling accurate risk assessment without requiring complex multi-parameter monitoring systems.

Inventive Principle:
Principle #24Intermediary (Mediator)

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

These methods allow for the determination of platelet aggregation and susceptibility to clotting, providing a basis for identifying individuals at risk of thromboembolic complications upon anti-CD40L antibody administration, enabling alternative therapeutic regimens.

Implementation Method 1

Upon activation, CD40L is translocated to the surface of platelets accompanied by surface appearance of CD63, P-selectin, and several other proteins

Methodology Applied
Scientific EffectTranslocation:

Implementation Method 2

contacting the activated platelets with an anti-CD40L antibody

Methodology Applied
Scientific EffectAntibody-antigen binding:

Implementation Method 3

contacting the activated platelets with a cross-linking agent

Methodology Applied
Scientific EffectCross-linking:

Implementation Method 4

aggregation is quantified by sedimentation of platelets

Methodology Applied
Scientific EffectSedimentation: Sedimentation

Data Source

PatentEP1955078B1Platelet aggregation assays
Publication Date: 2013.07.17 BIOGEN MA INC
  • EP1955078B1 patent drawingFigure 1
  • EP1955078B1 patent drawingFigure 2
  • EP1955078B1 patent drawingFigure 3

AI summary

The present invention provides methods of determining platelet aggregation, methods of determining susceptibility to clotting upon administration of a CD40L-binding moiety, and kits related thereto.