Regulatory guidelines have defined industry best practices around adventitious virus contamination and risk mitigation in terms of patient safety. Today, the industry is taking a closer look at minimizing the business risk associated with viral contamination and is taking a more directed view of risk mitigation. This approach includes virus prevention and detection, in addition to removal. From cell culture seed train to final fill vial, this presentation will describe: -Potential risks associated with different areas of biotech processes -What can be done to minimize adventitious virus risk in those areas. The overarching strategy of risk mitigation will include evaluation of raw materials, modified expression systems, environmental controls, upstream and downstream processing, as well as testing and regulatory considerations.