Four viral clearance service models offer time and cost saving options

By Dr. Jeri Ann Boose, Director, Eurofins Lancaster Laboratories Biopharmaceutical Services, USA

Viral clearance studies help ensure that an acceptable level of safety has been achieved for biological products. The goal of these studies is to demonstrate that the manufacturing purification process has the potential to inactivate or remove a broad range of virus types should an unexpected viral contamination event occur.

Typically, individual purification steps such as chromatography, solution inactivation and virus removal filtration steps are scaleddown from manufacturing-scale to bench-scale.

The starting material for each step is spiked with virus, and input and output samples are collected and quantitatively assayed for virus. The difference in virus quantity between the input and output samples represents the amount of virus cleared by the step.

As manufacturers cannot bring virus into their manufacturing facilities due to the risk of contamination, viral clearance studies are almost always performed in Eurofins Lancaster Laboratories’ viral clearance suites.

Sample generation usually involves the hands-on participation of the client. The time clients spend in the viral clearance suite equates to time spent away from manufacturing.

To alleviate this issue, Eurofins Lancaster Laboratories now offers four levels of service solutions. With the Level 1 Service Model, clients participate fully in the study. With the Level 2 Model, clients perform the more complicated processing steps, but Eurofins Lancaster Laboratories personnel assist by performing the less complicated steps. This can save the client’s days in the lab and also speeds the reporting time.

In the Level 3 Model, Eurofins Lancaster Laboratories scientists train on all client procedures and perform all the clearance steps, saving even more of the client’s time.

With the Level 4 Model, clients provide a complete description of the fullscale manufacturing process and Eurofins Lancaster Laboratories personnel develop and validate all scale-down models and generate all study samples.

These flexible service models enhance the client’s experience with significant time and cost savings, fostering a trusted strategic partnership between the client and Eurofins Lancaster Laboratories.

Contact: GMP_US@eurofins.com