Viral Clearance Service Levels 3 & 4 are in high demand
As clients seek to ensure the acceptable level of viral safety has been achieved for their biological products as well as establish a strategic outsourcing partnership, Eurofins Lancaster Laboratories’ Viral Clearance Service Levels 3 and 4 have become the trusted industry go-to.
“Our Viral Clearance Service Levels 3 and 4 have really taken off. We have methodically been earning the trust of more and more clients to expertly perform this higher level of service,” says Dr. Jeri Ann Boose. “As scientists, it’s a great endorsement to us personally that we are doing everything right.”
In addition to the Basic Level 1 and Enhanced Service Level 2 in which there is more client involvement on-site, Eurofins offers:
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.
For all stages throughout the development, manufacturing and release of a biological product, Eurofins Lancaster Laboratories offers comprehensive, fully cGMP-compliant Viral Clearance Services. And all assays are fully validated to meet ICH Q2 requirements. Scientists design and run studies to achieve regulatory acceptance, offering:
- A variety of validated and well characterized viral stocks to support animal and human-derived products
- Purified virus stocks
- High titer virus stocks
- 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 the manufacturing facility
Eurofins Lancaster Laboratories has six dedicated clearance suites for extensive capacity and timely execution and reporting of study results. As the only laboratory to offer a Viral Clearance Guarantee to ensure that clients’ clearance goals will be met, Eurofins Lancaster Laboratories’ hands-on approach to study management provides the attention needed and regulatory expertise for successful viral clearance studies.