Activated-Quenched Polysaccharide Reference Standard for Vaccine Quantification
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Existing reference standards for quantifying polysaccharides in vaccines using nephelometry are prone to degradation, leading to inaccurate estimation due to the instability of carrier proteins in monovalent conjugates.
Innovation Solution
A stable reference standard is created using activated-quenched polysaccharides, prepared by treating polysaccharides with an activating agent and quenching them with an amino acid, which replaces bulky carrier proteins and enhances the accuracy of polysaccharide quantification in vaccine compositions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If monovalent conjugate with carrier protein is used as reference standard, then polysaccharide quantification can be performed, but the reference standard degrades over time leading to inaccurate results
Solution Approach 1:
The patent extracts and removes the carrier protein component from the reference standard, using only the polysaccharide portion. This eliminates the degradation issue associated with carrier proteins while maintaining the polysaccharide-specific antibody binding capability, thereby resolving the contradiction between measurement precision and reference standard stability
Solution Approach 2:
The patent creates a simplified copy of the conjugate vaccine reference standard by using only the polysaccharide component without the carrier protein. This copy maintains the essential antigenic properties for antibody binding while eliminating the unstable carrier protein, thus achieving both accurate quantification and long-term stability
2Measurement precision
If carrier protein is included in reference standard, then immune complex formation occurs, but bulky carrier proteins interfere with accurate polysaccharide measurement
Solution Approach 1:
The patent extracts only the necessary polysaccharide component from the complete conjugate vaccine, removing the bulky carrier protein. This simplification eliminates interference with light scattering measurements while preserving the polysaccharide-antibody interaction needed for accurate quantification
Solution Approach 2:
Instead of using the conventional approach of including carrier protein to enhance immunogenicity, the patent inverts the approach by deliberately excluding the carrier protein from the reference standard, recognizing that for quantification purposes, the polysaccharide alone is sufficient and less interfering
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 activated-quenched polysaccharide standard provides stable and accurate quantification of polysaccharides in vaccines, maintaining stability for at least three months and improving the accuracy of polysaccharide content determination in both conjugate and unconjugated vaccine compositions.
Implementation Method 1
Nephelometry is a technique that is used for quantifying an analyte based on the principle of light scattering by the particles in the solution
Data Source
AI summary
The present invention provides a novel reference standard, comprising of activated-quenched polysaccharide, for quantifying polysaccharide content in a vaccine composition using nephelometry. The invention also provides a method for preparing the activated-quenched polysaccharide, for use as a reference standard. Further, a nephelometry based method for quantifying the polysaccharides in a multivalent conjugate vaccine is also provided. The reference standard of the present invention, comprising of the activated-quenched polysaccharide, is stable and can be used for accurate quantification of polysaccharides through nephelometry.