Regulatory agencies around the world have instituted increasingly stringent standards for viral clearance testing over the past decade. In the United States, the Food and Drug Administration requires comprehensive characterization and removal/inactivation validation for potential virus contamination in bio therapeutics like monoclonal antibodies, gene therapies, and vaccines. Similar guidelines from the European Medicines Agency and other international regulators have harmonized standards. As bio manufacturers develop more complex products incorporating modern protein engineering and cell/gene therapy techniques, meeting these regulations presents a greater technical challenge. This has significantly increased both the number of viral clearance studies required as well as their scope.

Viral Clearance Testing - https://www.coherentmi.com/blog/the-growing-viral-clearance-testing-evolution-of-regulatory-standards-drives-demand-125