Viral Clearance Testing
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 Clearance
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.
Hybrid Clearance
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.
Provise™ Clearance
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:
- Monoclonal antibodies
- Recombinant proteins
- Novel and biosimilar products
- Vaccines
- Gene therapy vectors - AAV
The outcome is confirmation that your viral clearance methodology supports your regulatory filing and manufacturing process.
BioPure virus stocks
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.
Related Resources
- Infographic: Viral Clearance Studies to Meet Your Timelines
Discover comprehensive clearance services to meet your needs.
- Flyer: BioReliance® Standard Viral Clearance Services
Learn how our experts, with decade of experience, help design and execute your clearance studies.
- Infographic: BioReliance® Viral Clearance Services
Discover key numbers on our experience with viral clearance studies.
- Application Note: Designing Successful Viral Clearance Studies
In this paper, we will share how to ensure your manufacturing process has the capacity to remove or inactivate enveloped and non-enveloped viruses.
- Flyer: Roadmap to Success — Provise® Clearance Services
Discover how we can do your viral clearance studies for you, keeping you informed along the way.
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