Fit for purpose testing and independent GMP validation of the monocyte activation test.

IF 2.9 Q2 TOXICOLOGY Current Research in Toxicology Pub Date : 2024-12-12 eCollection Date: 2025-01-01 DOI:10.1016/j.crtox.2024.100206

Ruth Daniels, Wim Van der Elst, Chi K So, Liesbeth Voeten, Philip Breugelmans, Marijke W A Molenaar-de Backer, Stephen Poole, Mehul Patel

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Abstract

The present study describes the "fit for purpose" testing and the independent product-specific GMP validation of the monocyte activation test (MAT) to detect pyrogenic and pro-inflammatory contaminants, MAT Method A, Quantitative Test (European Pharmacopoeia, Ph. Eur. chapter 2.6.30, 2017). A fit for purpose study was carried out to ensure that the chosen MAT set-up (cryopreserved PBMC, IL-6 detection) can reliably discriminate between batches of product containing pyrogenic contaminants below the contaminants limit concentration, CLC, from batches containing pyrogenic contaminants above the CLC. Such testing is carried out once, before the chosen MAT set-up is used for subsequent product testing to show that the incidence of false positives (pyrogen-negative (CLC) batches) and - especially - false negatives (pyrogen-positive (>CLC) testing as pyrogen-negative (

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适合目的测试和独立的GMP验证单核细胞活化试验。

本研究描述了用于检测热原和促炎污染物的单核细胞活化试验（MAT）的“适合目的”测试和独立产品特异性GMP验证，MAT方法A，定量测试（欧洲药典，Ph. Eur）。来自2.6.30章,2017)。进行了一项适合目的的研究，以确保所选择的MAT装置（冷冻保存的PBMC， IL-6检测）能够可靠地区分含有低于污染物极限浓度（CLC）的热原污染物批次和含有高于CLC的热原污染物批次。这种测试在选定的MAT设备用于后续产品测试之前进行一次，以显示假阳性（热原阴性（CLC）批次）和假阴性（热原阳性（>CLC））测试的发生率为热原阴性(

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