Related Experiment Video
Updated: Aug 20, 2025
Dynamic Monitoring of Seroconversion using a Multianalyte Immunobead Assay for Covid-19
Published on: February 16, 2022
30-Minute Highly Multiplexed VaxArray Immunoassay for Pneumococcal Vaccine Antigen Characterization
Tianjing Hu1, David F Miller1, Amber W Taylor1
1InDevR Inc., 2100 Central Ave., Suite 106, Boulder, CO 80301, USA.
Insights
A new VaxArray assay simplifies testing for pneumococcal vaccines. This multiplexed immunoassay identifies and quantifies 23 pneumococcal serotypes in under 30 minutes, improving vaccine characterization.
Area of Science:
- Vaccinology
- Analytical Chemistry
- Biotechnology
Background:
- Pneumonia causes significant global child mortality, particularly in low- and middle-income countries.
- Pneumococcal conjugate vaccines are crucial for reducing disease burden but are complex to manufacture and characterize.
- Existing characterization methods are often singleplex and time-consuming, requiring separate tests for identity and quantity.
Purpose of the Study:
- To develop and validate a novel multiplexed assay for comprehensive testing of pneumococcal vaccines.
- To provide a rapid and efficient method for identity, quantity, and stability assessment of pneumococcal polysaccharide and conjugate vaccines.
Main Methods:
- Development of the VaxArray pneumococcal assay, a microarray-based immunoassay kit.
- Application of the assay for simultaneous identification and quantification of 23 pneumococcal serotypes.
- Evaluation of assay performance with native polysaccharides, CRM197-conjugated polysaccharides, and final drug products.
Main Results:
- The VaxArray assay provides results in under 30 minutes.
- Demonstrated high reactivity and serotype specificity for various pneumococcal components.
- Achieved vaccine-relevant lower limits of quantification (low-to-mid ng/mL), even in adjuvanted vaccines.
- Showed excellent correlation with the anthrone assay, offering significantly improved precision.
Conclusions:
- The VaxArray pneumococcal assay is a powerful tool for efficient and accurate characterization of pneumococcal vaccines.
- This multiplexed immunoassay addresses limitations of current singleplex methods, enhancing vaccine quality control.
- The assay supports the development and manufacturing of diverse pneumococcal vaccines for global markets.
Abstract:
Pneumonia accounts for over 20% of deaths worldwide in children aged 1 to 5 years, disproportionately affecting lower- and middle-income countries. Effective, highly multivalent pneumococcal vaccines are available to decrease disease burden, with numerous new vaccines currently under development to serve a variety of worldwide markets. However, pneumococcal conjugate vaccines are among the hardest biologics to manufacture and characterize due to their complexity and heterogeneity. Current characterization methods are often inherently singleplex, requiring separate tests for each serotype present. In addition, identity and quantity are often determined with separate methods. We developed the VaxArray pneumococcal assay for applications in identity, quantity, and stability testing of pneumococcal polysaccharide and pneumococcal conjugate vaccines. The VaxArray pneumococcal assay has a time to result of less than 30 min and is an off-the-shelf multiplexed, microarray-based immunoassay kit that can identify and simultaneously quantify 23 pneumococcal polysaccharide serotypes common to many on-market and in-development vaccines. Here, we highlight the potential of the assay for identity testing by showing high reactivity and serotype specificity to a wide variety of native polysaccharides, CRM197-conjugated polysaccharides, and drug product. The assay also has vaccine-relevant lower limits of quantification in the low-to-mid ng/mL range and can be used for accurate quantification even in adjuvanted vaccines. Excellent correlation to the anthrone assay is demonstrated, with VaxArray resulting in significantly improved precision over this antiquated chemical method.
