Viral Safety Assurance

Viral safety is a critical aspect of biopharmaceutical/biologics production, and relies on the well-established principles of “prevent, detect, and remove” to assure drug safety for patients. These principles are the foundation of every viral safety strategy and depend on the approaches outlined below.

• Prevent: Careful selection and pretreatment of raw materials to prevent adventitious viruses from entering processes
• Detect: Testing for the presence of viruses and other adventitious agents in cell banks, raw materials, and process intermediates
• Remove: Implementation of technologies to remove or inactivate viruses and execute clearance studies to demonstrate process safety