Prevent, Detect, Remove

A partner with experience in all aspects of viral safety assurance can accelerate your drug development process and provide peace of mind.

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

As there is no single solution that works for every process, experts from MilliporeSigma are hoping to stimulate discussion by highlighting different aspects of viral safety for well-established platforms and newer virus-based therapies, including upstream, downstream, and regulatory considerations.

Viral Safety Process & Workflow