Our promise to you:
Guaranteed product quality, expert customer support.
24x7 CUSTOMER SERVICE
CONTACT US TO ORDER
Lentiviral vectors are widely used in gene therapy, CAR-T cell development, and in vivo gene delivery due to their high efficiency, ability to transduce both dividing and non-dividing cells, and long-term stable expression. They also offer a large cloning capacity and stable genome integration, making them one of the most versatile viral platforms.
However, during large-scale manufacturing, there is a potential risk of generating replication-competent lentivirus (RCL) through recombination with packaging components or host cell DNA. Even trace levels of RCL raise major biosafety concerns, including:
Therefore, sensitive and reliable RCL detection is a regulatory requirement and a cornerstone of safe clinical translation.
Figure 1. RCL assay principle.
Creative Biogene offers a comprehensive RCL testing service that combines gold-standard assays with rapid molecular methods, fully aligned with FDA and EMA regulatory guidelines.
| Assay | Principle | Advantages |
| Indicator Cell Culture Assay | Patient-derived or permissive cells are exposed to lentiviral preparations and passaged for 28 days; RCL replication is amplified and detected. | Gold standard; ensures replication-competent virus can be revealed. |
| p24 ELISA Assay | Detects the capsid protein p24 in supernatants of transduced cells. | Sensitive, quantitative, applicable to multiple sample types. |
| qPCR/PCR Assays | Detect lentiviral-specific sequences (e.g., VSV-G, psi-gag) generated by recombination. | High sensitivity, reproducible, faster turnaround. |
| PERT Assay | Measures reverse transcriptase activity associated with lentiviral replication. | Broad applicability across retroviral variants. |
We provide a stepwise RCL detection process optimized for research, GMP production, and regulatory submission support:
1Sample Verification: Quality and integrity check of lentiviral vector batches.
2Assay Selection: Customized assay design (indicator cell + rapid tests).
3Testing Execution: Parallel application of multiple validated assays.
4Data Cross-Validation: Results compared across methods for accuracy.
5Regulatory-Compliant Report: Full QC documentation with detailed results and interpretation.
Our RCL testing services are widely used across the biopharma pipeline:
We combine specialized expertise in lentiviral biosafety with validated assays and regulatory compliance.
Sample Types Accepted:
Final Deliverables:
Replication-competent lentivirus testing is essential for safe, effective, and regulatory-compliant clinical translation. With years of expertise and validated platforms, Creative Biogene provides fast, sensitive, and regulatory-aligned RCL detection tailored to your project needs. Contact us today to request a quote or schedule your RCL testing project.
Q: Why is RCL testing required in GMP production?
A: Regulatory agencies mandate RCL detection to ensure patient safety, particularly for CAR-T and gene therapy products.
Q: How long does the gold-standard indicator cell assay take?
A: Typically 28 days, but we offer rapid supplemental assays (ELISA, qPCR, PERT) for faster decision-making.
Q: Can Creative Biogene handle both research-grade and GMP samples?
A: Yes, we support R&D, IND-enabling studies, and GMP submissions.
Q: What methods are recommended by regulators?
A: A combination of indicator cell assay plus two orthogonal rapid assays (e.g., ELISA, qPCR, PERT) is standard.
Copyright © Creative Biogene. All rights reserved.