Fit for purpose testing and independent GMP validation of the monocyte activation test
Year: 2024
Type: article
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 (
Source: Current Research in Toxicology
Authors: Ruth Daniels, Wim Van der Elst, Chi K. So, Liesbeth Voeten, Philip Breugelmans, Marijke W.A. Molenaar-de Backer, Stephen Poole, Mehul Patel
Institutions: Janssen (Belgium), Sanquin, Johnson & Johnson (United Kingdom)
Language: English
Subfield: Analytical Chemistry
Field: Chemistry
Domain: Physical Sciences
Open Access status: gold
Estimated APC paid: $2,170
OpenAlex ID: W4405315342