Next Generation Sequencing revolutionises adventitious virus detection
Jeri Ann Boose, PhD, Senior Director of BioPharma Biologics, Eurofins Lancaster Laboratories, JeriAnnBoose@eurofinsUS.com; Thomas Brefort, PhD, Production Business Unit Manager NGS, Eurofins Genomics, ThomasBrefort@eurofins.com
Adventitious virus detection is an integral part of safety testing of biopharmaceutical products. Viral detection methods currently considered as industry standard generally fall into two categories:
- broad spectrum screening assays such as cell culture (in vitro) and animal (in vivo) based testing and transmission electron microscopy (TEM);
- target specific assays (typically qPCR).
While broad spectrum screening assays are able to detect a wide range of viruses, some may remain undetected due to diverse viral physiology and limitations in assay sensitivity. Target specific qPCR methods on the other hand are often highly sensitive, but can only detect pre-defined/known target(s). These target specific approaches are therefore used more often as tools to aid the investigation after a positive result has been identified during the broad screening assays.
Recently, Next Generation Sequencing (NGS) technology has revolutionised genome sciences. In recent years, NGS has been successfully adopted for the purpose of adventitious virus detection. NGS allows deep sequencing of all nucleic acids present in a given sample. When coupled with powerful bioinformatics, this has the potential to overcome the existing practical challenges and to provide a universal platform for not only detecting, but also identifying viruses with high sensitivity. Currently, the BioPharm industry continues to make ongoing efforts to optimise the assay and identify best practices for the full leverage of the many advantages NGS can offer to adventitious virus testing.
To this end, Eurofins Lancaster Laboratories and Eurofins Genomics (Ebersberg) have partnered and performed several successful NGS studies where contaminating viruses were quickly identified in biopharmaceutical samples of various matrices. With a turnaround time of preliminary results as quick as within one week, the findings have helped clients quickly identify the root cause of the contamination and implement appropriate corrective and preventative actions. It is also interesting to note that in a few cases, NGS was able to confirm that putative positive results were not related to viral contamination but rather false positive results due to the nature of sample/sample matrix, therefore allowing clients to avoid unnecessary and costly rejection of the manufactured materials. In addition to offering NGS testing services to our clients, Eurofins Lancaster Labs and Eurofins Genomics are also active members of the Advanced Virus Detection Technologies Interest Group (AVDTIG), a task force coordinated by PDA and joined by regulatory and industry experts.
For more information, visit: www.eurofins.com/biopharma; www.eurofins.com/genomic-services/our-services/nextgeneration- sequencing/