For all stages throughout the development, manufacturing and release of your biological product, Eurofins BioPharma Product Testing offers comprehensive, fully cGMP-compliant Viral Clearance Services.
We have six dedicated clearance suites for extensive capacity and timely execution and reporting of your study results. And all of our assays are fully validated to meet ICH Q2 requirements.
We are so confident in our Viral Clearance technical expertise, regulatory experience and study management approach, that we offer the only guarantee in the industry. We will work with you to design your viral clearance study, and if we do not meet your viral clearance goals, we will repeat it for FREE!
Why Choose Eurofins BioPharma Product Testing?
- We are the only laboratory to offer a Viral Clearance Guarantee to ensure that your clearance goals will be met.
- We bring together leading experts in the industry with extensive scientific and regulatory experience.
- Our hands on approach to study management provides you with the attention needed for your viral clearance study.
Viral Clearance Services
Our scientists design and run viral clearance studies to meet regulatory requirements. Our viral clearance offerings include:
- Variety of validated and well characterized viral stocks to support animal and human-derived products
- Purified virus stocks
- Viral stocks with titers of 107 pfu/ml or greater
- Validated qPCR assays
- Infectivity assays performed real-time
- Large Volume Assays
- Ongoing Regulatory Support Upon Study Completion
- Disinfectanct Efficacy and Cleaning Validation Studies designed to quantify the elimination of viruses during the cleaning procedures used at your manufacturing facility
Four Viral Clearance Models
Eurofins offers several service models for the performance of viral clearance studies:
- Level 1 – Basic Service: The client provides all materials and down-scale procedures and performs the study in Eurofins’ viral clearance suites.
- Level 2 – Enhanced Service: The client provides all materials and down-scale procedures and performs all column chromatography steps. Eurofins personnel perform inactivation and virus removal filtration steps.
- Level 3 – Full Service: The client provides all materials and down-scale procedures for transfer to Eurofins personnel, who perform all clearance steps.
- Level 4 – Turnkey Service: The client provides a description of the full-scale manufacturing process. Eurofins personnel develop and validate the down-scale procedures and perform all clearance steps.