Back The future of pyrogenicity testing: new approaches discussed at joint EDQM-EPAA event

EDQM Brussels, Belgium 27/02/2023
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The future of pyrogenicity testing: new approaches discussed at joint EDQM-EPAA event

The European Directorate for the Quality of Medicines & HealthCare (EDQM) and the European Partnership for Alternative Approaches to Animal Testing (EPAA) have just held a highly successful three-day joint event aimed at phasing out the rabbit pyrogen test (RPT) from the testing of pharmaceuticals worldwide. Held in the premises of the European Commission in Brussels, the conference marked a milestone in the history of both the RPT and the monocyte activation test (MAT), the in vitro alternative to the RPT.

The event kicked off with introductory talks from representatives of the European Commission, the EDQM and the EPAA, demonstrating the commitment of European institutions and EU member states to achieving their 3R goals (replacement, reduction and refinement of animal testing). In this context, phasing out the RPT by 2025-2026, as planned by the European Pharmacopoeia (Ph. Eur.) Commission, will contribute to a significant reduction in the number of rabbits used for experimental purposes in Europe.

On the second day of the conference, regulators from Europe and around the world shared their views on the replacement of the RPT. They all welcomed submissions of in vitro pyrogen tests and look forward to receiving an increasing number of dossiers with the appropriate validation data. International collaboration will be key to the wider acceptance of the MAT worldwide.

Pharmacopoeias from other regions (Brazil, China, India, Japan, United States) also joined the event and all committed to progressively phase out animal tests from their respective standards, including the RPT. For some of these organisations, this will take time but the commitment is there. It was extremely interesting to learn, from the World Health Organization representative present at the conference, that a similar path – promoting the MAT over the RPT – will be followed on a worldwide level.

The two-day conference was followed by a half-day training session on the MAT itself, providing tips and tricks for a successful switch to the MAT. This interactive session was a unique opportunity for stakeholders to directly engage with the specialists who shared their experience with implementing the MAT. The session and the following debate showed that from a technical point of view, in vitro methods – such as the MAT and the BET (bacterial endotoxin test) – can completely replace the RPT. Much has changed in the field of pyrogen testing since the MAT chapter was first published in the Ph. Eur. in 2010, particularly with the development and availability of standardised methods and robust kits. The initial investment of switching to MAT may be significant, but the benefits are multiple and undeniable. Industry representatives, in a specific session, explained their respective timelines for phasing out animal tests from their quality control facilities: the abolishment of RPT is scheduled for 2025.

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