Viral clearance
For all stages throughout the development, manufacturing and release of your biological product, Eurofins BioPharma Product Testing network of laboratories offers comprehensive, fully cGMP-compliant Viral Clearance Services.
We have four 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.
Why Choose Eurofins BioPharma Product Testing?
- We bring together leading experts in the industry with extensive scientific and regulatory experience.
- By supporting you from study planning through post-filing and working at your site, we can optimize your viral clearance study.
- Our hands on approach to study management provides you with the attention, and close communication, needed for the success of your viral clearance study through setting achievable timelines and clear and consistent expectations.
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
- Disinfectant Efficacy Studies (DES)
- Medical Tissue Device Studies
Facilities and Instrumentation
- Multiple HEPA-filtered virus clearance labs
- Multiple AKTA chromatography systems
- Spectrometers, pH meter, Conductivity meters and other basic lab equipment
- Capacity to accommodate studies with minimal delay
Viral Clearance Models
Eurofins BioPharma Product Testing network of laboratories offers two service models for the performance of viral clearance studies:
- Traditional Service: Eurofins personnel performs inactivation steps and provides batch records for performance. The client provides all materials and scale-down procedures and performs all chromatography and viral filtration steps. Deliverable is a report of virus results.
- Full Service: Eurofins personnel performs tech transfer and protein purification steps. The client provides all materials and is responsible for validation of scale-down procedures. Deliverable is a report of procedures performed and virus results.