Traditionally, in vivo testing has been used to measure a new product’s effectiveness and ensure the consumer’s safety via the prediction of toxicity, pyrogenicity and other safety indicators in pharmaceutical products, medical devices and biotherapeutics.
Following increasing awareness regarding animal welfare, scientists have been looking into alternative non-animal in vitro methods that could replace animals with tissues, cells and biomolecules undergoing complex testing within a highly controlled, artificial environment.
The main focus of our in vitro department is to establish new test systems for use within toxicology and develop in vitro or ex vivo methods to replace some of the testing currently carried out by our toxicology department.
The staff in this area are responsible for the development, validation and refinement of new and evolving in vitro testing methods. Throughout the course of the company’s development, we have successfully incorporated several in vitro methods into our service portfolio, including the Limulus Amebocyte Lysate bacterial endotoxin test and a 10993-5/USP 87 cytotoxicity test utilising cell culture sheets.
Our most recent development is the introduction of the Monocyte Activation Test (MAT), a non-animal in vitro alternative to the Rabbit Pyrogen Test, which is capable of detecting both endotoxin and non-endotoxin contamination in pharmaceutical products, biotherapeutics and medical devices.