Viruses replicate or grow within living organisms, from man to microbes. Therefore, any biological system used to generate biological or biopharmaceutical products could be contaminated with them.
Viruses can cause serious or fatal illness. Even those not known to be highly pathogenic, or to cause significant disease in humans, could potentially do so if introduced into an immune-compromised host and/or by a non-natural route of infection (e.g., intravenous or intramuscular inoculation rather than respiratory or oral spread). Some viruses can result in chronic infections, or persist silently within cells for long periods.
In this paper we explore the three principal and complementary approaches for the detection of viral contaminants in biologic-based medicines, and the identification of their origins, with our primary focus on the testing of source materials and products.
