Integrating 3Rs approaches in WHO guidelines for the batch release testing of biologicals: Reports from a series of NC3Rs stakeholder workshops.

A recent report presented to the WHO has highlighted significant opportunities for the implementation of 3Rs approaches (i.e. Replacement, Reduction and Refinement of animal tests) within their manuals, guidelines and recommendations for vaccines and biotherapeutics. The report is the culmination of a three-year project led by the UK National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs) and co-funded by the Bill & Melinda Gates Foundation. The aim was to review the extent to which animal-based testing methods are currently described in these internationally recognised guidance documents and recommend opportunities for applying the 3Rs. International stakeholders have been engaged throughout the project to gauge opportunities and barriers to adoption of 3Rs approaches and how these vary globally, to inform the recommendations in the report. This paper summarises the output from a series of international stakeholder workshops held between March 2022 and September 2023.