Supporting 3Rs approaches in biologicals testing
At a glance
Project overview
Up to 10 million animals a year are used worldwide in the development, production and quality control of biologicals such as vaccines (e.g. diphtheria, tetanus and polio), immunoglobulins (e.g. snake antivenoms), blood products and hormones. More than two-thirds of these animals are used for routine quality control batch release tests of licensed products. These tests are expensive, can cause significant pain and distress to the animals and have a high degree of variability which may cause lengthy delays of up to a year to the release of some biologicals and vaccines.
With previous Bill & Melinda Gates Foundation funding we have reviewed the animal testing requirements in World Health Organisation (WHO) guidelines for the quality control and batch release testing of vaccines and biological therapeutics. This follow-on project funded by the Gates Foundation will support delivery of the 3Rs impacts of our recommendations, driving their implementation and accelerating the adoption of the latest non-animal testing methods by the global biologics community. Embracing the latest advances in replacement technologies will support faster access to cheaper vaccines by the communities who need them most urgently.
Find out more about our project to review animal use requirements in WHO biologics guidelines.
Project aims
We aim to drive the global adoption of non-animal testing strategies in order to optimise quality control testing of biological products by:
Supporting the WHO in implementing the recommendations from our review.
Facilitating the uptake of existing non-animal technologies for batch release testing by global biologics manufacturers and regulators.
Supporting the development of new 3Rs approaches for batch release testing where they are needed most urgently, for example in assessing potency and neurovirulence.
Building an evidence base for the removal of obsolete animal tests.
Survey: Help us to shape the future of pyrogenicity testing of biologics
We want to hear about your experience with the MAT as a replacement for the rabbit pyrogen test – how you use and validate it, the cell types involved, and any barriers you face that make implementing the MAT challenging.
Your insights will help us to better understand current practices and inform our work to support the wider integration of 3Rs approaches in biologics quality control testing to drive wider adoption of non-animal approaches.
The survey closing date is 7 November 2025. It should take no more than 30 minutes to complete.
>> Download and complete the survey (XLSX, 180KB). <<
If you would like more information about the survey or the NC3Rs biologics project, please email Elliot: elliot.lilley@nc3rs.org.uk.
New WHO 3Rs guideline: Open for second public consultation
A draft guideline, produced by the World Health Organization (WHO) on the replacement or removal of animal tests for the quality control of biological products, is currently open for a second public consultation. The intention of this guidance is to support manufacturers and regulators to implement the 3Rs while product-specific WHO guidelines are being updated to integrate alternative approaches.
The call for comments is now closed. Submitted comments will be considered by the Expert Committee on Biological Standardization at its 81st meeting in October 2025.
This new guideline is in response to the recommendations from our review of the animal testing requirements in WHO quality control and batch release guidelines.
For more information, please email elliot.lilley@nc3rs.org.uk.
Steering committee members
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