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

点击翻译按钮获取中文摘要

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.