The rabbit pyrogen test replacement texts in Pharmeuropa 35.1 by the European Pharmacopoeia has been published for public comment.
The European Pharmacopoeia (Ph. Eur.) has published the 59 texts (One new general chapter, 5.1.13. Pyrogenicity, and 58 revised texts) concerned by the rabbit pyrogen test (RPT) replacement strategy for public consultation in Pharmeuropa 35.1.
Replacing the rabbit pyrogen test
The texts covering topics such as vaccines for human use, blood products, antibiotics, radiopharmaceuticals and containers, have now been revised to replace the RPT with an in vitro alternative, the monocyte activation test (MAT) or another animal welfare-compatible approach.
The publication is a significant step in the Ph. Eur. Commission’s strategy to completely replace the RPT in the Ph. Eur. The group envisage the shift will take place within the next three years.
In June 2021, the European Pharmacopoeia (Ph. Eur.) Commission decided to commit to replacing the RPT in the 59 Ph. Eur. texts, with a suitable in-vitro alternative, in about five years.
Pyrogens
The Ph. Eur. test for pyrogens consists of measuring the rise in body temperature in rabbits when they are injected intravenously with a sterile solution of the substance to be examined.
The Ph. Eur. Commission stated that the majority of pyrogens are bacterial endotoxins. These can be detected using the bacterial endotoxins test (BET), however non-endotoxin pyrogens may also be present. These are not detected by the BET. Therefore, a test covering all types of pyrogens is required to confirm the absence of non-endotoxin pyrogens.
General chapter 2.6.30. Monocyte-activation test (MAT), added in 2009, provided an in-vitro alternative to the RPT. It can detect both endotoxin and non-endotoxin pyrogens. While this offered an important option for detection of pyrogenic substances, rabbits continue to be used extensively to detect pyrogenic substances.
The organisations noted that users are actively encouraged to seek alternative methods, with the MAT identified as the best option.
Since the Ph. Eur. announced its decision on the rabbit pyrogen test replacement, users have had the opportunity to comment on the texts concerned.
Deadline for commenting on the RPT-relevant Pharmeuropa 35.1 texts is the 31 March 2023.
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