Characterisation of tetanus monoclonal antibodies as a first step towards the development of an in vitro vaccine potency immunoassay

Batch release testing for human and veterinary tetanus vaccines still relies heavily on methods that involve animals, particularly potency testing. The quantity quality of antigen present in these products is utmost importance product safety clinical effect. Immunochemical measure consistency content quality, potentially as an indicator potency, could be a better choice negate the need vivo test. These immunochemical require at least one well characterised monoclonal antibody (mAb) specific target antigen. In this paper we report results comprehensive characterisation panel mAbs against with view to select antibodies can used development vitro immunoassay. We have assessed binding native (toxin), detoxified (toxoid), adsorbed heat-altered Antibody function was determined using in-house cell-based neutralisation assay support prior data available some, but not all, antibodies. addition, affinity measured, epitope competition analysis performed identify pairs deployed sandwich immunoassay format. Not all tests provided evidence “superiority” mAb over another, together from studies allowed selection pair taken forward development.