2004 Award Winners
Award-winning project: In-vitro pyrogen test replaces animal testing
Project partners: Charles River GmbH | Steinbeis Transfer Center for In-Vitro Pharmacology and Toxicology/Konstanz
This is particularly significant for intensive care patients: with every injection, pyrogens could enter their bloodstream, further weakening them. Pyrogens are substances that, once in the bloodstream, can trigger acutely dangerous feverish reactions, organ failure and fatal shock. To ensure that medicines are pyrogen-free, the pharmaceutical industry has been increasingly relying on in vitro tests for several years now.
Unlike infections caused by live pathogens, pyrogens also include the dead remains or isolated chemical structures of bacterial pathogens. These elude normal sterilisation processes and thus pose a risk to humans. Health problems are by no means caused solely by pyrogens in injectable medicines. These fever-inducing substances can also enter the human bloodstream via technical and biological materials, such as artificial hips and implants, or via the air from air-conditioning systems. Because the previous method of detecting pyrogens using rabbit tests is ethically questionable, yet is still required today, the Steinbeis Transfer Centre for In-Vitro Pharmacology and Toxicology, based at the University of Konstanz, has developed and marketed an alternative testing method in collaboration with the globally operating US company Charles River Laboratories: the human in-vitro pyrogen test (IPT).
This test simulates the human fever response in a test tube, thereby detecting all known pyrogens in medical devices.
With the help of this new method, 80,000 animal experiments could be avoided annually in Germany alone. At the same time, the test enhances patient safety. With Charles River as its licensee and preferred partner, Steinbeis has big plans for the future. It is expected that air quality will soon be able to be assessed using in vitro pyrogen tests. This area of application is thought to have even greater market potential than the testing of medicinal products.