Validation of the Monocyte Activation Test Demonstrating Equivalence to the Rabbit Pyrogen Test.

ABSTRACT: The Monocyte Activation Test (MAT) is an in vitro assay that uses human blood cells to detect both endotoxins and non-endotoxin pyrogens (NEPs), representing a scientifically and ethically superior alternative to the in vivo Rabbit Pyrogen Test (RPT). In the European Pharmacopoeia (Ph. Eur.), the MAT is a compendial method which is explicitly recommended to replace the RPT, requiring only product-specific verification. In contrast, the United States Pharmacopeia (USP) lacks a dedicated MAT chapter, meaning the MAT can only be accepted as an alternative method, given that a full method validation according to USP <1225> is provided in addition to a product-specific verification. This study presents a two-tiered validation strategy addressing both regulatory frameworks: a generic (product-in

SUBMITTER: Burgmaier L 

PROVIDER: S-EPMC12652761 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature