Viral Clearance Studies
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!
Contact us at ViralClearance@eurofinsUS.com to find out more about our Viral Clearance Guarantee.
For all stages throughout the development, manufacturing and release of your biological product, Eurofins Lancaster Laboratories 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.
Why Choose Eurofins Lancaster Laboratories?
- 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
- Disinfectant 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 Lancaster Laboratories 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 Lancaster Laboratories’ viral clearance suites.
- Level 2 – Enhanced Service: The client provides all materials and down-scale procedures and performs all column chromatography steps. Eurofins Lancaster Laboratories 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 Lancaster Laboratories personnel, who perform all clearance steps.
- Level 4 – Turnkey Service: The client provides a description of the full-scale manufacturing process. Eurofins Lancaster Laboratories personnel develop and validate the down-scale procedures and perform all clearance steps.
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
Request more information to start working with us today. Or call one of our Business Development Specialists at 717-656-2300.