By Kristen Slawinski, Ph.D.
Viral safety is a key component to assuring the safety of biopharmaceuticals for human use. Manufacturers need to verify that their products are free of harmful viruses, while regulatory agencies are tasked with upholding standards for viral safety for all types of biopharmaceutical products. As live cells are used to express the biopharmaceutical product, and many of the components used in cell growth are of animal origin, the risks of virus contamination are high. New technologies and methodologies are emerging for both producing and testing biopharmaceuticals, so the industry is entering a new era of viral safety assurance.