VaxArray immunoassay for the multiplexed quantification of poliovirus D-antigen

Area of Science:

• Vaccinology
• Immunology
• Analytical Chemistry

Background:

• Next-generation poliovirus vaccines are crucial for global eradication.
• Current D-antigen ELISA assays for inactivated poliovirus vaccines are slow, inconsistent, and singleplex.
• Improved analytical tools are needed for vaccine characterization.

Purpose of the Study:

• To develop and validate a novel, multiplexed immunoassay for quantifying poliovirus D-antigen.
• To provide a faster, more consistent, and high-throughput alternative to traditional ELISA methods.
• To support the development and manufacturing of inactivated poliovirus vaccines.

Main Methods:

• Development of the VaxArray Polio Assay Kit, a microarray-based immunoassay.
• Utilizing poliovirus-specific human monoclonal antibodies for quantification.
• Simultaneous detection of all three poliovirus serotypes.

Main Results:

• The VaxArray assay provides results in under 3 hours, significantly faster than ELISA.
• Demonstrated suitable limits of quantification for bioprocess samples and final vaccines.
• Showed excellent reproducibility, precision, and improved accuracy compared to ELISA.
• Confirmed suitability for adjuvanted combination vaccines without interference from additives.

Conclusions:

• The VaxArray Polio Assay Kit is a robust, high-throughput tool for inactivated poliovirus vaccine characterization.
• This assay can streamline vaccine development and manufacturing processes.
• It aids in achieving global poliovirus eradication goals through improved vaccine quality control.