Multiplex Microsphere Assay for Botulinum Neutralizing Antibodies

Currently, the accepted standard experimental model for measuring protective efficacy against botulism is the Mouse Lethality Neutralization (MLN) assay. Botulism poisoning is a life threatening condition that is not only a public health concern, but could also be a potential biological weapon. With seven serotypes of botulinum neurotoxins, there is need for an alternative to the MLN assay due to the complexity of neutralizing a variety of these neurotoxins. Numerous MLN assays would be required to develop and produce cocktails of antibodies as protections against any combination of all seven botulism serotypes consuming time, resources and animals. In this Phase I, Agave BioSystems proposes to develop an accurate and sensitive in vitro assay to replace the Mouse Lethality Neutralization assay for testing botulinum neutralizing antibodies using flow cytometry microspheres in a 2 part assay. This microsphere-based assay can be multiplexed to cover all botulinum subtypes and has the flexibility to test cocktails of potential neutralizing antibodies to determine their efficacy. The two part in vitro assay will measure antibody affinity and neutralizing ability, two key features needed for effective, functionally active botulinum neurotoxins antibodies.