Virus Safety Of Biopharmaceuticals

Virus Safety of Biopharmaceuticals: Absence of Evidence is not Evidence of Absence

Author: Hazel Aranha, Ph.D., Catalent Pharma Solutions, Editor, Contract Pharma

Providing a definition for virus safety is nebulous at best. Industry and regulators recognize that the holy grail of viral safety β€” absolute freedom from extraneous agents or residual pathogenicity β€” is a myth. You find what you are looking for’ is a common axiom and nowhere is it more applicable than in the case of virus detection to ensure the safety of biopharmaceuticals. Recent reports of adventitious virus contamination of products and production environments have accentuated the necessity of a holistic approach to virus safety. This paper reviews the approaches applied to ensure viral safety and discusses some of the recent contamination incidents.