Validation of a triple‐color pseudovirion‐based neutralization assay for immunogenicity assessment of a 14‐valent recombinant human papillomavirus vaccine

Abstract

Validation of bioanalytical methods is crucial, especially in the pharmaceutical industry, to determine their suitability for specific purposes and the accuracy of analytical results. The pseudovirion‐based neutralization assay (PBNA) is considered the gold standard for detecting and quantifying neutralizing antibodies against human papillomavirus in vaccine development for disease prevention. This paper introduces an improved triple‐color PBNA method, capable of simultaneous detection of two or three human papillomavirus (HPV types for use in the development of a 14‐valent HPV vaccine candidate. The primary objective was to comprehensively validate the triple‐color PBNA method for general vaccine immunogenicity assays. Results show that the method has good specificity, accuracy, precision, linearity, robustness, and applicability. This innovative triple‐color PBNA offers an improved approach for large‐scale immunogenicity assessment in vaccine development. This study lays a solid foundation that can serve as a guiding paradigm for assessing vaccine responses in preclinical and clinical phases, providing valuable insights to the field.