title: Application of an in vitro endopeptidase assay for detection of residual toxin activity in tetanus toxoids.
abstract: Tetanus vaccine is composed of chemically denatured tetanus toxin (TeNT), thus safety testing requires confirmation of freedom from residual and reversible toxicity. Currently, TeNT activity is estimated using in vivo assay models. Information that TeNT acts by selectively inactivating protein leading to the blocking of release of neurotransmitters has provided the opportunity to develop in vitro biochemical assay for toxin activity. In this study we describe development and use of an in vitro endopeptidase assay for detection of TeNT activity in toxoid vaccine formulations.
authors.affiliation: National Institute for Biological Standards and Control, Potters Bar, Hertfordshire, UK.
authors.forename: T
authors.initials: T
authors.lastname: Leung
authors.forename: P H
authors.initials: PH
authors.lastname: Corran
authors.forename: C
authors.initials: C
authors.lastname: Gee
authors.forename: T A N
authors.initials: TA
authors.lastname: Ekong
authors.forename: D
authors.initials: D
authors.lastname: Sesardic
mesh_terms: D000826:Animal Testing Alternatives; D001681:Biological Assay; D010450:Endopeptidases / Q000378:metabolism*; D066298:In Vitro Techniques; D008565:Membrane Proteins / Q000235:genetics / Q000378:metabolism; D009419:Nerve Tissue Proteins / Q000235:genetics / Q000378:metabolism; D050683:R-SNARE Proteins; D013744:Tetanus Toxin / Q000032:analysis* / Q000276:immunology / Q000633:toxicity; D013745:Tetanus Toxoid / Q000737:chemistry* / Q000633:toxicity; D018675:Toxicity Tests / Q000379:methods*
chemical_list: D008565:Membrane Proteins; D009419:Nerve Tissue Proteins; D050683:R-SNARE Proteins; D013744:Tetanus Toxin; D013745:Tetanus Toxoid; D010450:Endopeptidases