30-Minute Highly Multiplexed VaxArray Immunoassay for Pneumococcal Vaccine Antigen 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.