Stable D-dimer Liquid Preparation Using Fibrinogen Mediator
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Solution Overview
Problem
Current D-dimer control and calibrator preparations in liquid form have limited shelf life, leading to unstable recovery of the analyte D-dimer, especially when stored at 37°C, necessitating the development of a stable liquid D-dimer preparation.
Innovation Solution
A D-dimer-containing buffer matrix with added fibrinogen in concentrations of 0.1 g/L to 1 g/L, preferably 0.2 g/L to 0.5 g/L, is used to create a stable liquid preparation that maintains constant D-dimer recovery for up to 24 weeks at 37°C, as opposed to preparations without fibrinogen which degrade within 10 weeks.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If D-dimer preparations are stored in liquid form without fibrinogen, then ease of operation is improved, but shelf life and stability deteriorate after 10 weeks at 37°C
Solution Approach 1:
Fibrinogen is introduced as an intermediary substance that mediates between the D-dimer analyte and the buffer matrix. The fibrinogen creates a protective microenvironment that prevents D-dimer degradation while maintaining liquid form, effectively acting as a stabilizing mediator that extends shelf life without compromising usability
Solution Approach 2:
The invention changes the compositional parameters of the buffer matrix by adding fibrinogen at specific concentrations (0.1-1 g/L). This parameter change transforms the chemical environment to one that supports D-dimer stability in liquid form, extending the effective shelf life from 10 weeks to 24 weeks at 37°C while maintaining the liquid state
2Duration of action of stationary object
If D-dimer preparations are lyophilized, then shelf life is improved, but ease of operation and preparation complexity worsen
Solution Approach 1:
The invention extracts and eliminates the need for lyophilization processing by introducing fibrinogen into the liquid buffer matrix. This removes the complex drying and freezing process requirement while maintaining extended shelf life, allowing the product to remain in simple liquid form without requiring lyophilization equipment or processes
Solution Approach 2:
By changing the compositional parameters to include fibrinogen, the invention alters the stability characteristics of the D-dimer preparation, enabling it to maintain stability in liquid form for 24 weeks at 37°C, thereby eliminating the need for lyophilization while achieving comparable or superior shelf life
3Reliability
If fibrinogen is added to D-dimer buffer matrix, then stability and shelf life are improved, but manufacturing precision requirements worsen
Solution Approach 1:
The invention establishes an optimized concentration range for fibrinogen (0.1-1 g/L, preferably 0.2-0.5 g/L) that provides sufficient stability enhancement while maintaining reasonable manufacturing tolerances. This parameter optimization balances the need for stability with the practical constraints of manufacturing precision
Solution Approach 2:
The invention creates a composite buffer matrix system combining buffer solution, D-dimer, and fibrinogen in specific proportions. This composite formulation leverages the stabilizing properties of fibrinogen while distributing the precision requirements across multiple components, making the overall system more robust to manufacturing variations
Data Source
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AI summary
The invention lies in the field of coagulation diagnostics and relates to a liquid, buffer matrix-based D-dimer preparation which additionally contains fibrinogen and which is suitable as a standard material for control or calibration purposes for D-dimer test procedures.