Until now, the detection of the entire variety of pyrogens (fever-inducing contaminants) in pharmaceuticals was based on the rabbit pyrogen test. 400,000 rabbits are still used for this purpose per year worldwide. Nevertheless regulatory validated test methods are available with quicker and handier based on in vitro test methods. This regulatory shift will enter into force this Summer 2016 under the EU Pharmacopeia 5.1.10.
This one-day session is the opportunity to be prepared for the upcoming regulatory changes by discovering the Monocyte activation test or MAT presented by Dr. Spreitzer (Chair of the EDQM Working Party Bacterial Endotoxin Test) as well as hands-on-training with two different endotoxin tests that participants will perform. Those kits will be provided by Lonza and Hyglos.
Participants will develop their basic knowledge on pyrogens and endotoxins mode of action as well as a strong focus on the upcoming regulatory testing requirements. Moreover, a wide range of samples will be tested by the participants such as complex matrices, spiked pharmaceuticals (e.g. Antibiotics), water samples and medical devices.