Batch release testing for human and veterinary tetanus vaccines still relies heavily on methods that involve animals, particularly for potency testing. The quantity and quality of tetanus antigen present in these products is of utmost importance for product safety and clinical effect. Immunochemical methods that measure consistency of antigen content and quality, potentially as an indicator of potency, could be a better choice and negate the need for an in vivo potency test. These immunochemical methods require at least one well characterised monoclonal antibody (mAb) that is specific for the target antigen. In this paper we report the results of the comprehensive characterisation of a panel of mAbs against tetanus with a view to select antibodies that can be used for development of an in vitro potency immunoassay. We have assessed binding of the antibodies to native antigen (toxin), detoxified antigen (toxoid), adsorbed antigen and heat-altered antigen. Antibody function was determined using an in-house cell-based neutralisation assay to support prior in vivo potency data that was available for some, but not all, of the antibodies. In addition, antibody affinity was measured, and epitope competition analysis was performed to identify pairs of antibodies that could be deployed in a sandwich immunoassay format. Not all characterisation tests provided evidence of “superiority” of one mAb over another, but together the results from all characterisation studies allowed for selection of an antibody pair to be taken forward to assay development.

人用和兽用破伤风疫苗的批量放行测试仍然严重依赖涉及动物的方法，尤其是效力测试。这些产品中破伤风抗原的数量和质量对产品安全和临床效果至关重要。测量抗原含量和质量一致性的免疫化学方法，可能作为效力的指标，可能是更好的选择，并且不需要进行体内效力测试。这些免疫化学方法需要至少一种对靶抗原具有特异性的充分表征的单克隆抗体 (mAb)。在本文中，我们报告了一组抗破伤风 mAb 的综合表征结果，以期选择可用于体外开发的抗体。效力免疫测定。我们已经评估了抗体与天然抗原（毒素）、解毒抗原（类毒素）、吸附抗原和热改变抗原的结合。使用内部基于细胞的中和试验来确定抗体功能，以支持先前可用于某些（但不是全部）抗体的体内效力数据。此外，还测量了抗体亲和力，并进行了表位竞争分析，以鉴定可以部署在夹心免疫测定形式中的抗体对。并非所有表征测试都提供了一种 mAb 优于另一种 mAb 的证据，但所有表征研究的结果一起允许选择抗体对以进行检测开发。