Binding and cleavage (BINACLE) assay for the functional in vitro detection of tetanus toxin: Applicability as alternative method for the safety testing of tetanus toxoids during vaccine production

Highlights • BINACLE (combined BINding And CLEavage) assay detects active tetanus neurotoxin. • BINACLE represents an alternative method for safety testing of tetanus toxoids. • BINACLE is a valuable tool for consistency monitoring during vaccine production. • Assay sensitivity is comparable to the...

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Bibliographic Details
Published in:Vaccine 2013-12, Vol.31 (52), p.6247-6253
Main Authors: Behrensdorf-Nicol, Heike A, Bonifas, Ursula, Hanschmann, Kay-Martin, Krämer, Beate, Weißer, Karin
Format: Article
Language:English
Subjects:
Allergy and Immunology
animal tests
Applied microbiology
Biological and medical sciences
detection limit
functional properties
Fundamental and applied biological sciences. Psychology
Ganglioside GT1b
guinea pigs
in vitro studies
In vitro toxicity assay
Microbiology
monitoring
neurotoxins
proteolysis
risk
safety testing
Sensitivity and Specificity
Synaptobrevin
Technology, Pharmaceutical - methods
tetanus
Tetanus neurotoxin
Tetanus Toxin - metabolism
Tetanus Toxin - toxicity
Tetanus Toxoid - adverse effects
Tetanus Toxoid - isolation & purification
Tetanus Toxoid - standards
toxicity
toxicity testing
Toxoids
Toxoids - metabolism
Toxoids - toxicity
vaccines
Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects)
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Summary:Highlights • BINACLE (combined BINding And CLEavage) assay detects active tetanus neurotoxin. • BINACLE represents an alternative method for safety testing of tetanus toxoids. • BINACLE is a valuable tool for consistency monitoring during vaccine production. • Assay sensitivity is comparable to the currently prescribed in vivo toxicity tests. • Higher specificity for toxin detection in toxoids than other in vitro assays.
ISSN:0264-410X
1873-2518
DOI:10.1016/j.vaccine.2013.10.028