Ensuring biosafety in cell therapies: Replication Competent Lentivirus Testing (RCL) with digital PCR
Why Replication Competent Lentivirus testing (RCL) is critical
Lentiviral vectors are potent tools in cell and gene therapy, thanks to their ability to stably integrate genetic material into both dividing and non-dividing cells. However, ensuring the safety of these vectors is paramount, especially for cell therapy products.
Even though modern lentiviral vectors are engineered to be replication incompetent, there remains a risk of replication-competent lentivirus (RCL) formation due to recombination or contamination events. This rare occurrence presents a potential safety risk, making replication-competent lentivirus testing essential during both production and clinical phases.
At TATAA, we develop, qualify, and validate fit-for-purpose assays to support drug developers with reliable and efficient lentiviral testing.
We detect the physical titer of lentivirus (total viral particles) using conserved regions as qPCR targets, with assays designed in compliance with regulatory requirements. For replication-competent lentivirus (RCL) testing, using digital PCR assays that are fast, cost-effective, specific, and validated, depending on the context of use.
Our services include:
- Replication-competent lentivirus (RCL) detection to ensure patient safety and regulatory compliance.
- Viral genome titer quantification to determine the amount of therapeutic vector particles.
- Vector copy number (VCN) determination
By combining optimized assays, streamlined protocols, and advanced dPCR technology, we deliver absolute quantification of viral titers and VCN. Optimized and qualified workflows enable robust, reproducible, and scalable lentiviral testing.
dPCR for sensitive and absolute quantification
To detect RCLs, digital PCR (dPCR) is increasingly the method of choice. It offers:
- Absolute quantification of specific DNA targets
- High sensitivity, with limits of detection (LOD) down to single copy numbers
- Fast turnaround times
- High-throughput capacity
Compared to traditional infectivity or culture-based assays, qPCR and dPCR provide a more efficient and scalable solution, especially during clinical trial phases.
Fit-for-purpose assay design and validation
Each RCL test is tailored to your needs:
- Sample-specific extraction workflows
- Custom assay design for your target sequences
- Validated for regulatory readiness, aligned with your development phase
- Regulatory readiness: Designed with scalability and future regulatory requirements in mind
Regulatory-compliant and scalable testing
We are:
- GLP accredited for qPCR and dPCR
- GCLP compliant for qPCR and dPCR
- Equipped with high-throughput instrumentation to scale testing during clinical trials
With deep expertise in cell and gene therapy, we ensure that replication competent lentivirus testing becomes a smooth and streamlined part of your development program.