A particular problem with intensive care patients is that pyrogens can enter the bloodstream whenever they receive an in jec tion, making them even weaker. Pyrogens are substances capable of inducing acute, highly dangerous fever, organ failure and potentially: toxic shocks. To make sure medicines are totally free of pyrogens, the pharmaceutical industry has been using in-vitro testing for years.
In contrast to infections caused by living pathogens, with pyrogens you also have to deal with the dead remnants or fragmented chemical structures of bacterial pathogens. They manage to sidestep normal sterilization processes, thus posing major risks to humans. However, the havoc wreaked by pyrogens comes not only from injections. They can also enter the body through modern technology, in materials such as replacement hips and implants, or even through the air supplied by conditioning systems, setting off serious fever. There may still be strong demand for the type of guinea pig testing used to date to identify pyrogens, but it has come under a great deal of scrutiny for ethical reasons. As a result, the University of Constance-based Steinbeis Transfer Center In-Vitro Pharmacology and Toxicology joined forces with the US company Charles River Laboratories to develop an alternative testing method, and bring it to market. The result was the human In-Vitro Pyrogen Test (IPT) which simulates human beings’ high temperature in a test tube, making it possible to detect the full range of known pyrogens in medicines. In Germany alone, the new method prevents 80,000 animal tests a year. It also makes life for patients safer. Steinbeis has high hopes for its work with Charles River, which has been awarded the license and appointed preferred partner.
Soon it is hoped to test air quality by using in-vitro pyrogen tests. Theoretically, the approach has even greater market potential, beyond the testing of medicines.
Prof. Dr. Albrecht Wendel
Steinbeis Transfer Center In-Vitro Pharmacology and Toxicology, Constance