Four Viral Clearance Service Models Offer Time and Cost Saving Options
by Jeri Ann Boose, Ph.D., director, Biopharmaceutical Services
Viral clearance studies are a critical element toward ensuring that an acceptable level of viral safety has been achieved for biological products. The goal of these studies is to demonstrate that the manufacturing purification process has the ability to inactivate and/or remove a broad variety of virus types, including those viruses known to contaminate or which may possibly contaminate the starting materials.
Typically, individual processing steps in the manufacturing process, such as column chromatography, solution inactivation, and virus removal filtration steps, are scaled down from manufacturing- scale to bench-scale. In the viral clearance study, the input material for each step is spiked with high titer virus, and both input and output samples from the step are collected and quantitatively assayed for virus. The difference in the amount of virus spiked into the step and that found in the output sample 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 in a viral clearance study has almost always involved the hands-on participation of the client. In the most common scenario, Eurofins Lancaster Laboratories’ personnel and client personnel work side-by-side to set up the studies, spike the steps with virus, and collect the samples for analysis in the virus testing laboratory.
The time clients spend in the viral clearance lab equates to time spent away from their manufacturing responsibilities. Eurofins Lancaster Laboratories is aware that sending client personnel to assist in the generation of viral clearance samples can be an inconvenience for many clients due to a shortage of personnel, lack of time and travel costs.
To alleviate this issue, Eurofins Lancaster Laboratories now offers clients several levels of service solutions for viral clearance study performance.
The Basic Level 1 Service Model is offered to those clients who wish to continue providing all materials and procedures for the study and who wish to be at Lancaster to participate hands-on in the performance of the full study. This model used to be the most common service model selected, but that is no longer the case.
For some time, we have also offered an Enhanced Level 2 Service Model in which the client still provides all the materials and procedures for the study. The client also comes to Eurofins Lancaster Laboratories and is hands-on for the performance of the more complicated manufacturing processing steps, but Eurofins Lancaster Laboratories’ personnel assume responsibility for performance of the more straight-forward processing steps such as solution inactivation and virus removal filtration. The Level 2 Model has the benefit of saving the client significant time in the viral clearance suite as samples can be generated from multiple processing steps simultaneously. More efficient sample generation also results in faster reporting time. This service model is now the one most commonly used by our clients.
Our newest service model is the Full Service Level 3 Model. As for Models 1 and 2, the client provides all the materials and validated scale-down procedures for the steps being tested in the study. However, the client does not participate in the hands-on, sample generating portion of the study. Instead, Eurofins Lancaster Laboratories’ personnel will train on all the procedures as part of a documented technical transfer and perform all the clearance steps. The advantage is that client personnel do not need to travel to Lancaster for the study. While this model requires extra time for the technical transfer portion of the study, the growing number of clients who favor this model indicates that the benefit of Eurofins Lancaster Laboratories’ operators performing the complete study far outweighs the additional time.
Eurofins Lancaster Laboratories is now pleased to offer a Turnkey Level 4 Service Model for viral clearance. The client has one responsibility in this model and that is to provide Eurofins Lancaster Laboratories with a complete description of the full-scale manufacturing process. Eurofins Lancaster Laboratories’ personnel will then develop and validate all scale-down models for each step to be tested and will generate the samples for each individual step. The deliverable is a self-standing final report which covers the full scope of the study from scale-down development and validation to the viral clearance study results.
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.
For more information on how these Viral Clearance Service Models can achieve your timelines cost-effectively, contact BioPharmaceutical Business Development at 717-656-2300.