The European Pharmacopoeia (Ph. Eur.) is officially removing the Rabbit Pyrogen Test (RPT). From 1 July 2025, this method may no longer be used in accordance with supplement 11.8. This makes it clear that switching to animal-free methods is not only ethically necessary, but also mandatory from a regulatory perspective.
The key question for biopharmaceutical manufacturers is: Which alternative fulfils the regulatory requirements and is user-friendly and fast at the same time?
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