Adventitious virus testing using next‑generation sequencing provides sensitive, untargeted detection of DNA and RNA viral contaminants to strengthen risk assessment and ensure the safety of gene therapy and other biologic products.
BaseClear’s Adventitious Virus Testing (AVT) is performed to confirm that the sample, biological product or raw material is free from unexpected, and unwanted, viral contaminants. Using advanced sequencing technologies, we screen your samples for both known and unknown viruses that could affect product safety or manufacturing quality. Our team handles the full process: from sample preparation and sequencing to bioinformatic analysis and interpretation, so you receive a clear, reliable assessment of viral safety.
This service is ideal for biotech and pharmaceutical companies working on gene therapies, vaccines, recombinant proteins, or any other biologic where viral safety is essential. It supports projects at many stages, including early development, raw material qualification, process monitoring, and batch release, helping organizations mitigate contamination risks and meet evolving regulatory expectations. AVT is especially valuable for teams who need a broad, unbiased method to detect viruses that traditional targeted assays might miss.
Our AVT workflow is built around next-generation sequencing (NGS) technology, which allows us to scan your sample for a wide range of viral genomes without needing to know what we’re looking for in advance. We combine optimized automated laboratory steps with powerful bioinformatic tools to identify any viral signatures present. For added confidence, digital PCR (dPCR) is available as an optional orthogonal method for targeted confirmation, quantification, and assay development support.
We deliver AVT results that satisfy regulatory expectations and give you the analytical confidence needed for risk assessment and submissions. You receive a clear, comprehensive report that summarizes the results and explains what they mean for your product. This includes sequencing data, identified viral sequences, and expert interpretation from our scientific team. We also provide all raw and processed data files, making the results suitable for regulatory submissions or internal risk assessments.
You reach out to our team with your project goals, sample types, and timelines so we can understand your needs from the start.
We schedule a short call to discuss your requirements in detail and shape a workflow that fits your product, matrix, and regulatory context. We are here to fully customize to your need.
Once the project is approved, you send your samples to our laboratory, where we prepare, sequence and analyze them using the agreed-upon workflow.
Our scientists review the sequencing results, perform bioinformatic analysis, and interpret any viral signatures in the context of your product and risk profile.
You receive a structured, easy-to-use report with all data, findings, and expert conclusion. We can walk you through the results, answer questions, and discuss any follow-up testing or additional support you may need.
Genomics and sequencing projects completed
Years of sequencing and genomics expertise
Validated molecular analysis workflows
Cell culture samples analysed
Most AVT workflows require only a modest amount of material, and the exact volume depends on the sample type and the sequencing depth needed. We discuss these details with you before submission to make sure you provide the right amount, and not more than necessary.
Our NGS‑based AVT method delivers high sensitivity for detecting low‑abundance viral sequences across a wide range of matrices. Sensitivity is driven by optimized extraction, deep sequencing, and stringent bioinformatic filtering, enabling detection levels suitable for regulatory‑aligned viral safety assessments.
The AVT workflow is compatible with a wide range of sample types, including cell banks, viral vectors, raw materials, in-process samples and final drug substances. Its flexible preparation protocols allow it to handle complex matrices such as serum-derived components or high-background biological materials.
Turnaround time depends on sample type and project scope, but most AVT projects follow a defined workflow that includes preparation, sequencing, bioinformatic analysis, and reporting. Timelines are communicated upfront so you know exactly when to expect your results.
Yes. The final report includes sequencing data, identified viral sequences, and expert interpretation, along with all raw and processed data files. This documentation is structured to support regulatory filings and internal risk assessments.
Most AVT workflows require only a modest amount of material, and the exact volume depends on the sample type and the sequencing depth needed. We discuss these details with you before submission to make sure you provide the right amount, and not more than necessary.
Speak with our experts to discuss your cell line identification project. We will help you determine the appropriate analysis approach and provide reliable sequencing results to support your research and quality control workflows.
