MAT Survey by the British NC3Rs

We have reported several times in the recent past on global activities to avoid and reduce animal testing. We have also reported that regulatory authorities for medicinal products in individual countries are increasingly incorporating this topic into their objectives and plans. Among other things, this is also an issue in the field of pyrogen testing of medicinal products, where the classic rabbit test is increasingly being replaced by alternative methods such as MAT.

The National Centre for the Replacement, Refinement & Reduction of Animals in Research (NC3Rs) has now launched a survey on MAT in close collaboration with other authorities such as the FDA, the German PEI and representatives of the pharmaceutical industry. The background to this project and its objectives are presented by the NC3Rs as follows:

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."

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"

Direct contact, presentation and discussion of the results

Representatives of the NC3Rs will present the initial results at PharmaLab 2025 on 25/26 November at the Endotoxin and Pyrogen Conference and will also be available to talk to at an information stand during the conference breaks.

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