Global availability of critical reagents for biologicals testing - Current status, challenges and possible solutions

This is the authors' abstract. We don't add key points for this paper.

On July 2, 2024, the International Alliance for Biological Standardization (IABS) and Humane Society International (HSI) co-hosted a webinar on the global availability and affordability of critical reagents for vaccine and biologics production. Despite growing support for non-animal testing, significant barriers remain, especially in low-income countries facing financial and supply chain challenges. This meeting showcased successful collaborations on reagent production and shared industry and regulatory perspectives. Key barriers included high reagent costs, import complexities, and the limited number of suppliers. Participants stressed the need for tailored risk-based testing, in-house assay validation, and stronger collaboration for standardised testing. The idea of regional hubs in Africa and Southeast Asia for reagent distribution was also discussed to address logistical challenges. A central theme was advocating reliance strategies, which promote shared regulatory assessments and resource optimisation, as demonstrated by the EU/EEA OCABR Network activities and South African-European laboratory collaborations. Difficulties facing smaller national control laboratories in meeting international standards were highlighted, along with the need for further innovation in non-animal-derived reagents to address these challenges. Participants stressed the importance of continued global collaboration and adopting reliance practices to improve access to critical reagents and ensure sustainability in biologics testing. • Reliance strategies promote regulatory convergence, cut needless testing, and optimise resources. • Regional distribution hubs can ease difficulties in importing reagents containing animal components. • Adapting testing strategies reduces reagent costs and addresses some availability issues. • Employing risk-based testing can help phase out costly animal testing for legacy vaccines. • Development of viral standards for implementation of molecular test methods can facilitate reducing animal use.