On 9 and 10 March 2021, a workshop aimed at facilitating the implementation of replacement in vitro toxicity and antigenicity assays for Clostridium septicum vaccine antigens was jointly organised by the European Directorate for the Quality of Medicines & HealthCare (EDQM/Council of Europe), the European Partnership for Alternative Approaches to Animal Testing (EPAA) and the European Commission’s Joint Research Centre (JRC). Also on the agenda was a discussion of the regulatory consequences of the related revisions to veterinary vaccine monographs undertaken by the European Pharmacopoeia Group of Experts on Veterinary Vaccines and Sera (15V) and the potential for international harmonisation.
This workshop is the follow-up of a collaborative study (BSP130) conducted under the Biological Standardisation Programme (BSP), co-funded by the European Union and the EDQM/Council of Europe. Fourteen manufacturers and public-sector control laboratories were enrolled in an international study run under the common aegis of the EDQM and the EPAA. The study allowed the validation of Vero cell-based assays as alternatives to the mouse tests currently in use for in-process quality control of Clostridium septicum vaccines (toxicity: Minimum Lethal Dose; antigenicity: Total Combining Power). The results demonstrated that optimised Vero cell-based assays represent valuable toxicity and antigenicity indicators as alternatives to the corresponding in vivo methods. Implementation of such cell-based testing for this and other cytotoxic antigens, using this study as a model, could ultimately result in large reductions in animal usage in the quality control of veterinary vaccines. Experimental work toward the extension of the concept to other clostridial toxins was presented.
For more information, read the press release “Phasing out animal testing for in-process control of veterinary vaccines: Clostridium septicum as a proof of concept”.