Development of monoclonal antibodies suitable for use in antigen quantification potency tests for clostridial...

The quality control testing of clostridial veterinary vaccines currently requires large numbers of animals. Alternative in vitro test methods are being investigated by researchers in industry and by regulatory authorities in many countries. Monoclonal antibodies that neutralize Clostridium perfringens alpha toxin, C. perfringens beta toxin, C. perfringens epsilon toxin, and C. sordellii lethal toxin as well as a monoclonal antibody directed against C. chauvoei flagellar antigen have been developed by the Center for Veterinary Biologics-Laboratory for use in antigen quantification assays. A proposal to create an international standard collection of clostridial-specific monoclonal antibodies is made.