Newsletters >> Winter 2016 >> Viral Clearance

Clients rave about our viral clearance services and guarantee

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“Your team’s expert assistance, execution, and turnaround times far exceeded my expectations for our viral clearance study.”- Scientist in Downstream Bioprocessing, Manufacturing and Technology, Mid-Size Biopharm Company

“Great group to work with. Lots of experience in viral safety validation, super insight into what the regulators expect and excellent sanity check for experimental design and strategy documentation. We plan to work with Eurofins Lancaster Labs to compile our complete viral safety package.”- Vice President and Ph.D., Process Development, Mid-Sized Biopharm Company

“We have been very happy with the Level 3 service offered by Eurofins Lancaster Labs for viral clearance studies. The scientists’ expertise in understanding and performing our scale-down model experiments has been very good. Scientists are quite open and flexible in incorporating our customized ideas for study design, data collection and data reporting.” - Director and Ph.D., Global Biologics Firm

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. It is a way for us to show our clients that we believe in our product and ensure that your clearance goals will be met.

Approaching each study design as a collaboration between the client and our team, we have detailed discussions with the client regarding the product purification process and the clearance targets for each individual spiking virus. Our management team has over 80 years of combined experience in viral clearance, has served on multiple task forces, is actively engaged with global regulators and has helped many clients defend their data to regulatory agencies. This regulatory support continues for the life of the product.

Because our team implements an on-going best practices program to evaluate and optimize all the parameters of study design and performance, we evaluate multiple options for performing a study and offer a design that we can recommend and guarantee as the best way of achieving viral clearance targets.

We offer several study options ranging from basic virus spiking to a complete turnkey model. For our Basic Service model, we provide the virus spike, and the client is on site to perform each process step. The client is also on site for our Enhanced Service model, but our staff will perform the less complicated steps (e.g., inactivation and viral filtration steps). For our Full Service model, we perform a technology transfer of the scaled down model (previously qualified by the client), and then our staff will perform the entire study without the client being present. Finally, our Turnkey Service model involves design and qualification of a scale down model and performance of the complete viral clearance study. The final data includes a CMC-ready scale down and viral clearance reports.

For all stages throughout the development, manufacturing and release of your biological product, we offer comprehensive, fully cGMP-compliant viral clearance services, and all of our assays are fully validated to meet ICH Q2 requirements.

Our new facility has four completely independent client suites, including laboratory and office space, which are conveniently located, providing constant access to our personnel during a client’s stay. Each suite has separate keycard access, keeping all client information confidential.

Viral clearance offerings include:

  • A 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

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

Beyond our state-of-the-art instrumentation and facilities, we have some of the industry’s top scientific talent who transform science into an outstanding service experience. Approaching each study as a vested partnership, when a client’s study succeeds, we all succeed.