Sunday, 4 July 2021

End of the pyrogen test looms in Europe!


On 28th June 2021 EDQM declared that rabbit pyrogen testing will end in Europe by 2026. Although most companies have moved away from the test, a few continue and some monographs continue to provide the option. This is a further development of the EU ‘3Rs’ process: Replacement,Reduction and Refinement of the use of animals for test purposes.

Here is the link: https://www.edqm.eu/en/news/european-pharmacopoeia-put-end-rabbit-pyrogen-test

The European Commission states:

The majority of pyrogens are bacterial endotoxins and these can be detected using the bacterial endotoxins test (BET) described in Ph. Eur. general chapters 2.6.14. Bacterial endotoxins and 2.6.32. Test for bacterial endotoxins using recombinant factor C. However, in some cases, non-endotoxin pyrogens may also be present and these are not detected by the BET. A test covering all types of pyrogens is therefore required to confirm the absence of non-endotoxin pyrogens.

General chapter 2.6.30. Monocyte-activation test (MAT) was added to the Ph. Eur. in 2009, providing an in-vitro alternative to the RPT that is capable of detecting both endotoxin and non-endotoxin pyrogens. The publication of this chapter was a significant step forward in terms of animal welfare, in accordance with the Council of Europe’s European Convention for the Protection of Vertebrate Animals used for Experimental and Other Scientific Purposes.

However, despite multiple efforts since then to encourage developers to apply the MAT instead of the RPT, rabbits continue to be used extensively to detect pyrogenic substances.

There are currently 59 Ph. Eur. texts – covering a variety of topics including vaccines for human use, blood products, antibiotics, radiopharmaceuticals and containers – that refer to the RPT and will be affected. The Ph. Eur. is committed, for all these texts, to replacing the test for pyrogens with a suitable in-vitro alternative, ultimately leading to the complete elimination of the RPT. In the meantime, users are actively encouraged to seek alternatives to chapter 2.6.8, the best option being the MAT.

Aside from the complexities, this is something  I’ve long been advocate of. LAL is specific, superior and does not breed rabbits to be killed. In addiion, where non-endotoxin pyrogens are of a concern, the Monocyet Activation Test is available.

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

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