Beijing Engineering Research Center of Protein and Antibody, Sinocelltech Ltd., Beijing, China.
Beijing Key Laboratory of Monoclonal Antibody Research and Development, Sino Biological Inc., Beijing, China.
J Med Virol. 2024 Aug;96(8):e29859. doi: 10.1002/jmv.29859.
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.
验证生物分析方法至关重要，特别是在制药行业，以确定它们是否适用于特定目的以及分析结果的准确性。基于假病毒的中和测定法（PBNA）被认为是检测和定量疫苗开发中针对人乳头瘤病毒（HPV）的中和抗体的金标准，可用于预防疾病。本文介绍了一种改良的三色 PBNA 方法，能够同时检测两种或三种人乳头瘤病毒（HPV）类型，用于开发 14 价 HPV 疫苗候选物。主要目的是全面验证三色 PBNA 方法在一般疫苗免疫原性测定中的适用性。结果表明，该方法具有良好的特异性、准确性、精密度、线性、稳健性和适用性。这种创新的三色 PBNA 为疫苗开发中的大规模免疫原性评估提供了一种改进方法。本研究为评估临床前和临床阶段疫苗反应提供了坚实的基础，为该领域提供了有价值的见解。
