Publications by authors named "Tinne Appels"
Article Synopsis
- Pharmaceutical products for injection must be free from pyrogenic contamination, which includes endotoxins from certain bacteria and other microbial sources.
- The rabbit pyrogen test has been the traditional method for detecting pyrogens, but in 2010, the monocyte activation test (MAT) was introduced as a non-animal alternative in the European Pharmacopoeia.
- This study presents the first product-specific validation of Ph. Eur. MAT for testing three therapeutic monoclonal antibodies, using cryopreserved blood cells and interleukin-6 as a readout, with data from one antibody aiding in a successful product license application.
