Supporting 3Rs approaches in biologicals testing: responses from a survey of Manufacturers, Contract Research Organisations, National Control Laboratories and National Regulatory Authorities.

In October 2023, the UK National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs) presented recommendations to the World Health Organisation (WHO) Expert Committee for Biological Standardization following an audit of WHO vaccine and biotherapeutic guidelines. These recommendations aimed to promote greater and more harmonised adoption of 3Rs principles (i.e. Replacement, Reduction and Refinement) in quality control and batch release testing. Building on the success of the WHO audit, the NC3Rs initiated a new project to accelerate wider adoption of 3Rs approaches for batch release testing by global biologics manufacturers and regulators. To facilitate this, a survey was developed and distributed to individuals who work for biologicals manufacturers, contract research organisations, national regulatory authorities and national control laboratories. This paper presents the key findings from the survey and outlines how these insights will inform the NC3Rs' ongoing work to advance the wider integration of 3Rs approaches in quality control and batch release testing of vaccines and biotherapeutics.