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3 results on '"Liesbeth Voeten"'

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

Author

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

Subjects
MAT, RPT, GMP validation, Fit for purpose testing, Validation the non-compendial method, United States Pharmacopoeia (USP), Toxicology. Poisons, RA1190-1270
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 (

Published
2025
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2. Validation of the monocyte activation test with three therapeutic monoclonal antibodies

Author

Ruth, Daniels, Wim, Van der Elst, Nele, Dieltjens, Tinne, Appels, Chi K, So, Thomas, Nys, Liesbeth, Voeten, Philip, Breugelmans, Marijke W A, Molenaar-de Backer, Eelo, Gitz, Stephen, Poole, and Mehul, Patel

Subjects
Endotoxins, Pharmacology, Medical Laboratory Technology, Pyrogens, Leukocytes, Mononuclear, Animals, Antibodies, Monoclonal, Rabbits, General Medicine, Animal Testing Alternatives, Monocytes
Abstract

Pharmaceutical products intended for parenteral use must be free from pyrogenic (fever-inducing) contamination. Pyrogens comprise endotoxins from Gram-negative bacteria and non-endotoxin pyrogens from Gram-positive bacteria, viruses, and fungi. The longstanding compendial test for pyrogens is the rabbit pyrogen test, but in 2010 the monocyte acti-vation test (MAT) for pyrogenic and pro-inflammatory contaminants was introduced into the European Pharmacopoeia (Ph. Eur.) as a non-animal replacement for the rabbit pyrogen test. The present study describes the first product-specific Good Manufacturing Practice validation of Ph. Eur. MAT, Quantitative Test, Method A for the testing of three therapeutic monoclonal antibodies. The study used the MAT version with cryo-preserved peripheral blood mononuclear cells and interleukin-6 as the readout. Much of the data presented here for one of the antibodies was included in a successful product license application to the European Medicines Agency.

Published
2022
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3. Quantification of **Candida albicans** by flow cytometry using TO-PRO®-3 iodide as a single-stain viability dye

Author

Monique Kerstens, Paul Cos, Louis Maes, Peter Delputte, Mario Hellings, Liesbeth Voeten, Isabel Pintelon, and Gaëlle Boulet

Subjects
Microbiology (medical), Quantification methods, Iodide, Colony Count, Microbial, Microbiology, Stain, Flow cytometry, Plate count, Candida albicans, medicine, Molecular Biology, Biology, chemistry.chemical_classification, Chromatography, Microbial Viability, biology, medicine.diagnostic_test, Staining and Labeling, Carbocyanines, biology.organism_classification, Flow Cytometry, Chemistry, chemistry, Human medicine
Abstract

This study investigated a flow cytometric, single-stain approach to quantify Candida albicans as an alternative for the standard viable plate count. TO-PRO®-3 iodide allows an excellent distinction between viable and dead cells. Both quantification methods show a high degree of correlation.

Published
2013

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