ALTEX. 2022 Apr 14. doi: 10.14573/altex.2111301. Online ahead of print.
ABSTRACT
Pharmaceutical products intended for parenteral use must be free from pyrogenic (fever-inducing) contamination. Pyrogens comprise endotoxin from Gram-negative bacteria and non-endotoxin pyrogens (NEP) from Gram-positive bacteria, viruses and fungi. The longstanding compendial test for pyrogens is the rabbit pyrogen test (RPT) but in 2010 the monocyte activation test (MAT) for pyrogenic and pro-inflammatory contaminants was introduced into the European Pharmacopoeia (Ph. Eur.) as a ‘non-animal’ replacement for the RPT. The present study describes the first product-specific GMP validation of Ph. Eur. MAT, Quantitative test, Method A, for the testing of three therapeutic monoclonal antibodies (mAbs). The MAT uses cryo-preserved PBMC with interleukin-6 (IL-6) as the readout. Much of the data presented here for one of the antibodies was included in a successful product licence application to the EMA.
PMID:35502618 | DOI:10.14573/altex.2111301
