Development of a Cell-Based Assay for Tetanus Vaccine Quality Control

破伤风疫苗是世卫组织预防破伤风的全球基本药物。该疫苗是由破伤风毒素（类毒素）的解毒形式制成的，在使用之前必须证明其无活性。许多动物被用于疫苗的安全性测试，这在伦理上是有问题的，昂贵的，耗时的和不可靠的，因此显著增加了制造商的生产成本。Sansanima的目标是在这种基本药物的生产中取代动物试验。为了实现这一目标，谢菲尔德大学的研究小组开发了一种高度创新的基于细胞的检测方法，可以测量破伤风毒素的生物活性。这种颠覆性的技术是定量的，高度可重复的，并且比动物试验快得多，因此有可能对这种基本药物的生产产生变革性的影响。为了评估该检测方法的有效性，谢菲尔德大学的研究小组组建了一个由13家破伤风疫苗制造商和药品和保健产品管理局代表组成的国际联盟。在研究的第一阶段（由NC3R资助），谢菲尔德大学的团队将使用制造商提供的材料评估该检测方法，并进一步优化该技术，使其完全商业化。在研究的第二阶段，Sansanima将向制造商转让技术，并为制造商提供关键试剂、培训和技术支持。我们正在向Innovate UK申请资金，以组建一个能够交付和实施该计划的团队。

Tetanus vaccine is a WHO Essential Global medicine to prevent tetanus. The vaccine is made from a detoxified form of tetanus toxin (toxoid), which must be shown to be inactive before it can be used. Many animals are used in the safety testing of the vaccine, which is ethically questionable, expensive, time consuming and unreliable so significantly increases the production costs for the manufactures. It is the aim of Sansanima to replace animal testing in the manufacture of this essential medicine. To achieve this the team at the University of Sheffield have developed a highly innovative cell-based assay which can measure the biological activity of tetanus toxin. This disruptive technology is quantitative, highly reproducible, and significantly faster to perform than animal testing so has the potential to have a transformative impact on the production of this essential medicine. To evaluate the effectiveness of the assay, the team at the University of Sheffield, has assembled an international consortium of 13 Tetanus vaccine manufacturers and representatives from the Medicines and Healthcare products Regulatory Agency. In the first phase of the study, (funded by the NC3Rs) the team at the University of Sheffield will evaluate the assay using material provided by the manufactures and further optimise the technology so it is fully commercially ready. In the second phase of the study, Sansanima will transfer the technology to the manufacturers and will provide critical reagents, training and technical support for the manufacturers. We are requesting funds from Innovate UK to assemble a team which can deliver and implement this plan.