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Work funded by the NC3Rs at the University of Sheffield has led to the development of a cell-based reporter assay that has the potential to replace thousands of animal tests currently used in the production of tetanus and botulinum vaccines. Tetanus neurotoxin is a large protein which poisons spinal cord neurons and blocks neurotransmission, leading to paralysis and death. Vaccine manufacturers produce thousands of batches of tetanus vaccine annually, using inactivated preparations of the tetanus neurotoxin (called tetanus toxoids). To exclude the risk of residual toxicity, each batch of tetanus toxoid undergoes strict safety testing. Up to now, these prescribed safety tests have to be performed as in vivo toxicity tests in guinea pigs or mice. These tests use tens of thousands of animals annually and inflict significant suffering, normally assigned the highest severity limits by regulatory authorities.
Professor Bazbek Davletov and his colleagues from the University of Sheffield have engineered immortalised mouse neurons expressing a stabilised reporter molecule which when cleaved by the active tetanus toxin can be detected with high sensitivity using an enzymatic reporter. Now they are seeking partners to help further develop, validate and commercialise the assay. They are specifically looking for expertise to:
- Further standardise the assay by incorporating highly specific monoclonal antibodies, aptamers or affibodies which recognise the tetanus-cleaved end of the VAMP polypeptide.
- Assist in selecting the most sensitive clonal cell lines using real toxoid samples.
- Further develop the assay for improved detection of botulinum neurotoxin activity.
Conservative assessments suggest that up to 60,000 guinea pigs and mice are used globally in tetanus vaccine production each year for human and veterinary purposes. These bioassays induce neuromuscular paralysis and are normally assigned the highest severity limits by regulatory authorities. The successful development and application of this new cell-based assay has the potential to replace many of these animal tests.
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