Biosafety research in medicine: Effects of endogenous retroviruses present in some well-established or experimental biomedical procedures

Retroviruses are known as the causative agents of numerous animal disorders. In humans, this virus family is responsible for AIDS, certain forms of leukemias, and some neurologic disorders. The development in our laboratory of an ultrasensitive test for the retroviral enzyme reverse transcriptase has made possible detection of retroviruses present at very low concentration [1]. This test, the so-called PERT assay (for Product-Enhanced Reverse Transcriptase), is meanwhile used worldwide for detection or, respectively, exclusion of unknown retroviruses in biomedical products. Negative results with the PERT assay are, for example, requested for FDA-approval of all newly developed live attenuated virus vaccines produced in mammalian cells. This test — whose validation was decisively supported by the SPP Biotech Program of the SNF — has thus resulted in a significant increase in the retroviral safety of biomedical products.