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NC3Rs | 20 Years: Pioneering Better Science
Office-led project

Review of animal use requirements in WHO biologics guidelines

A set of resources to support the adoption of the 3Rs in quality control and batch release testing of vaccines and biological therapeutics
Needle in a vial of vaccine

With co-funding from the Bill & Melinda Gates Foundation, we have reviewed World Health Organization (WHO) manuals, guidelines and recommendations for vaccines and biological therapeutics to identify the extent to which animal-based testing methods are described. The principle aim of this review was to recommend where updates to these documents could lead to an increased and more harmonised adoption of the 3Rs in quality control and batch release testing requirements. Improved adoption of the 3Rs and non-animal testing strategies will help to reduce the delays and costs associated with product release testing.  
 

See our project page for more information and to access related publications: Review of animal use requirements in WHO biologics guidelines.

Project outputs

Comprehensive report detailing our recommendations for the wider integration of the 3Rs within WHO quality control and batch release testing guidelines for biological products (PDF, 1.2MB).

A searchable database of all animal tests identified during our review of WHO guidelines with recommendations for the implementation of the 3Rs.

We have engaged with global stakeholders to inform our recommendations throughout this project, recordings from our workshops can be found here.