Viral Safety Approaches For Advanced Therapy Medicinal Products

By Thomas R. Kreil, Ph.D., Shire

The availability of plasma-derived medicinal products— one of the earliest achievements of medical biotechnology—has enabled great progress in the treatment of specialized conditions such as hemophilia and immune deficiencies. Yet early on, the biologic materials used to develop these products were also found to be vulnerable to infectious disease agents. Today, manufacturers safeguard these products during the development process through a set of measures commonly referred to as the “Safety Tripod.”