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
There is no single viral safety solution that works for every process. Working with a partner with experience in all aspects of viral safety assurance can accelerate your drug development process and provide peace of mind.