Development and Implementation of a Single Radial Diffusion Technique for Quality Control of Acellular Pertussis Vaccines

被引：0

作者：

Wu, Chongyang ^{[1
]}

Wang, Xi ^{[1
]}

Zhou, Yu ^{[2
]}

Zhu, Xinshuo ^{[2
]}

Ma, Yu ^{[2
]}

Wei, Wenming ^{[1
]}

Zhang, Yuntao ^{[3
]}

机构：

[1] Beijing Inst Biol Prod Co Ltd, Dept Res & Dev, Beijing 100176, Peoples R China

[2] Beijing Inst Biol Prod Co Ltd, Bacterial Vaccine Mfg Facil, Beijing 100176, Peoples R China

[3] China Natl Biotec Grp Co Ltd, Beijing 100024, Peoples R China

来源：

VACCINES | 2025年 / 13卷 / 02期

关键词：

acellular pertussis vaccine components; antigen content quantification; single radial immunodiffusion; analytical methods validation; quality control; INFLUENZA HEMAGGLUTININ ANTIGEN; IMMUNODIFFUSION TECHNIQUE; TOXIN; ASSAY; DETOXIFICATION; FORMALDEHYDE; INFECTION; PROTECT;

D O I：

10.3390/vaccines13020116

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

Background/Objectives: An assay for protein content is essential but insufficient for quality control of acellular pertussis vaccines, which might consist of up to five components, each needing individual quantification. Generally, purified pertussis antigens such as pertussis toxin (PTx), filamentous haemagglutinin (FHA), and pertactin (PRN) should be detoxified or stabilized chemically before being formulated into vaccine bulk. The use of chemical agents like formaldehyde and glutaraldehyde can alter the immunological reactivity of these antigens, rendering direct assays by methods such as ELISA ineffective. Methods: In this study, a simple method based on single radial diffusion (SRD) using low concentrations of polyclonal antisera against PT toxoid (PTd), FHA, and PRN was developed. By adding a detergent, diffusible subunits are produced regardless of the original physical state of the antigens, making it suitable for quantifying these antigens after chemical treatment. Results: The assay has shown good specificity, accuracy, and precision. Furthermore, it can differentiate between preparations with the same protein concentration but different antigenic contents. A significant positive correlation between the antigen content and the in vivo immunogenicity has also been demonstrated. Conclusions: An assay for quality control and consistency monitoring of combined vaccines containing acellular pertussis antigen components has been established.

引用

页数：12

共 23 条

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