Our viral clearance studies are designed and executed by experts in regulatory requirements, downstream processing, and virology. Having performed more than 17,300 viral clearance studies in our U.S., UK, China, and Singapore facilities, you can trust in us to minimize risk as you bring your product to market.
We offer three different regulatory-accepted service packages:
Standard Viral Clearance Service lets you book study time in our state-of-the-art suites. Working closely with our highly experienced team, you’ll maintain full control and responsibility for running the viral clearance protocol, relying on us to provide the virus spike and perform all necessary titrations.
The Hybrid approach balances our Standard and Provise™ Service packages, with our expert team working in partnership with you to deliver a robust and reproducible viral clearance protocol.
Our Provise™ Clearance Service lets you focus on your core work while our experts take full responsibility for technical transfer and performance of your viral clearance protocol, along with a detailed report.
Whichever service model you choose, we perform IND- and BLA-enabling studies to meet global regulatory requirements for biologics:
The outcome is confirmation that your viral clearance methodology supports your regulatory filing and manufacturing process.
We use BioPure™ virus to ensure high viral titers and low levels of potential contaminants, translating to outstanding performance for all downstream process studies. BioPure™ virus stocks are produced from fully-characterized virus stocks and are used to evaluate the reduction of virus.
BioPure™ Gold virus is used for nanofiltration steps for additional sensitivity, as it’s been subjected to additional purification to produce the cleanest and most aggregate-free material.
Your viral clearance partners will discuss the use of virus stocks in your specific studies.