The viral safety testing plan for biologics is important in ensuring the safety of these products prior to them moving forward into clinical studies and eventually being released onto the market. There are many different pillars to a strong viral safety plan. These include in vivo and in vitro testing of both the products and the raw materials that go into the products. Also included in many viral safety plans for products produced in eukaryotic hosts are viral clearance studies. These methods add a layer of checks and balances and fulfill regulatory requirements in order to receive the proper approvals to move products from one phase to the next in development.
As technologies advance, companies gain access to more powerful tools to look at the viral safety profile of their products at different stages in the process. This gives them the opportunity to be proactive and use these tools to their benefit in making their products safer. One advanced method, next generation sequencing (NGS), has been known to the industry for quite a few years and more recently task groups have been set up by the FDA in order to examine its advantage in viral safety testing. Also in 2018 Europe put in place regulations (EP 9.3) suggesting the addition of NGS testing to vaccine products. As the industry begins to move towards NGS it is important that companies begin to explore and education themselves on this method.
Charles River recently announced the expansion of their collaboration with Pathoquest for next generation sequencing services. What does this mean to you? This partnership is giving you easy access to this advanced technology, education around it, and the scientific and BioIT experience of Pathoquest through Charles River.
Key features of Pathoquest’s NGS testing include:
- The use of a metagenomic approach, which enables testing of all biological ingredients from the R&D stage through to batch release of marketed products. This approach can also be used in contamination investigations (rush results within < 3 days)
- Employs the use of highly accurate Illumina® and Nanopore® sequencing systems enabling precise genome analysis to document the vector and insertion site sequences in modified cells and vectors
- A fully integrated service from sample preparation to actionable report, including review and signature by an expert virologist or geneticist
- Robust and powerful bioinformatics tools including an automated BioIT pipeline and a secured private data center
- Ability to identify a broad range of viruses, including still unknown viruses
- Ability to use one comprehensive test instead of multiple assays, saving time and money
- Accelerate your drug development by ensuring a fast, comprehensive viral safety testing package
- Decrease your risk of a false positive by applying the PathoQuest viral safety NGS transcriptome approach
- De-risk your drug development pipeline using a broad-range, powerful safety test
- Metagenomics NGS Services offered by PathoQuest are fast, cost-effective, and fully integrated
Next generation sequencing is not only for viral safety testing of your products but can also be applied in genetic stability testing, cell line characterization efforts and the testing of media and raw materials. If you have questions or would like to request a quote you can contact us at [email protected].