开发用于测定白喉疫苗抗原含量和质量的单克隆抗体夹心酶联免疫吸附试验。

IF 4.5 2区 医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL
Altex-Alternatives To Animal Experimentation Pub Date : 2024-01-09 Epub Date: 2023-08-07 DOI:10.14573/altex.2305251
Laura Hassall, Daniel A Yara, Rebecca Riches-Duit, Peter Rigsby, Alexandre Dobly, Maxime Vermeulen, Antoine Francotte, Paul Stickings
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引用次数: 0

摘要

目前,生产商和国家控制实验室对白喉疫苗的质量控制主要依靠体内检测来确认效力。作为 VAC2VAC 项目的一部分,我们开发了一种单克隆抗体 (mAb) 酶联免疫吸附试验 (ELISA),用于测量白喉-破伤风疫苗中白喉类毒素 (DTxd) 的相对数量和质量,并认为该试验有可能在不再包括体内效价试验的控制策略中发挥关键作用。该 mAb 酶联免疫吸附试验具有高度特异性和良好的稀释线性,适用于检测一系列不同人用疫苗产品中的 DTxd。我们已经证明,该检测方法能够利用含有不同数量 DTxd 或因受热或氧化应激而发生变化的疫苗批次来区分不同含量和质量的批次。我们还成功地将该方法转移到了其他实验室,并证明不同的白喉抗原材料可以作为该方法本地标准化的参考抗原。该检测方法非常适合纳入白喉疫苗质量控制常规检测的一致性方法中,并可能适合作为稳定性指示检测,以取代目前的体内效价检测。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Development of a monoclonal antibody sandwich ELISA for the determination of antigen content and quality in diphtheria vaccines.

At present, quality control of diphtheria vaccines by both manufacturers and national control laboratories relies heavily on in vivo assays to confirm potency. As part of the VAC2VAC project we have developed a monoclonal antibody (mAb) enzyme-linked immunosorbent assay (ELISA) to measure the relative amount and quality of diphtheria toxoid (DTxd) in diphtheria-tetanus based vaccines and believe this test has the potential to play a key role in a control strategy no longer including an in vivo potency test. The mAb ELISA is highly specific, has good dilutional linearity, and is suitable for detecting DTxd in a range of different human vaccine products. We demonstrate the ability of the assay to discriminate between batches of different content and quality using vaccine batches that were prepared to contain differing amounts of DTxd or were altered by exposure to heat or oxidative stress. We also demonstrate successful transfer of the method to other laboratories and show that different diphtheria antigen materials may be able to serve as a reference antigen for local standardization of the method. The assay is ideally suited for incorporation into a consistency approach for routine diphtheria vaccine quality control testing and may be suitable to serve as the stability indicating test in replacement of the current in vivo potency test.

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来源期刊
Altex-Alternatives To Animal Experimentation
Altex-Alternatives To Animal Experimentation MEDICINE, RESEARCH & EXPERIMENTAL-
CiteScore
7.70
自引率
8.90%
发文量
89
审稿时长
2 months
期刊介绍: ALTEX publishes original articles, short communications, reviews, as well as news and comments and meeting reports. Manuscripts submitted to ALTEX are evaluated by two expert reviewers. The evaluation takes into account the scientific merit of a manuscript and its contribution to animal welfare and the 3R principle.
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