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Characterization of pneumococcal conjugates in vaccine process development by multi-detection hydrodynamic
Xiujuan Jia1, James Z Deng1, Michael A Winters2
1Analytical Research & Development, Merck & Co., Inc., Rahway, NJ, USA.
Journal of Pharmaceutical and Biomedical Analysis
|March 23, 2025
Summary
This study introduces a new hydrodynamic chromatography method (HDC-MALS) for characterizing pneumococcal conjugate vaccines (PCVs). This faster technique accurately measures molecular weights, crucial for vaccine quality control.
Area of Science:
- Vaccine development and characterization
- Analytical chemistry
- Biotechnology
Background:
- Pneumococcal conjugate vaccines (PCVs) require precise molecular weight monitoring during production.
- Current gold standard size-exclusion chromatography (SEC-MALS) can be time-consuming.
- Accurate characterization of large, heterogeneous conjugates is essential for vaccine efficacy.
Purpose of the Study:
- To develop and validate a multi-detection hydrodynamic chromatography (HDC-MALS) method for PCV analysis.
- To enable rapid and comprehensive characterization of pneumococcal conjugate vaccines.
- To improve in-process control during PCV manufacturing.
Main Methods:
- Development of an optimized multi-detection (MALS, UV, RI) hydrodynamic chromatography (HDC) method.
- Application of HDC-MALS for molar mass distribution analysis of PCV conjugates.
- Comparison of HDC-MALS with traditional SEC-MALS and field flow fractionation (FFF).
Main Results:
- The HDC-MALS method provides accurate absolute molecular weight characterization of PCVs.
- Granular molar mass distribution analysis effectively characterizes heterogeneous, large conjugates.
- HDC allows for high mobile phase flow rates, leading to faster analysis times compared to SEC and FFF.
Conclusions:
- HDC-MALS is a powerful and efficient technique for comprehensive PCV characterization.
- This method facilitates in-depth understanding of the vaccine conjugation process.
- The rapid turn-around time of HDC-MALS is suitable for demanding in-process control.
Keywords:
CRM(197)Hydrodynamic chromatographyMulti-angle light scatteringPneumococcal conjugate vaccineMore Related Videos
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