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Adenoviral vectors have become indispensable in gene therapy, vaccine development, and recombinant protein expression due to their high transduction efficiency and ability to infect both dividing and non-dividing mammalian cells. However, during large-scale production, replication-competent adenovirus (RCA) may emerge through recombination with host sequences or contamination.
Even at very low levels, RCA can amplify during vector passaging, leading to:
These risks make sensitive RCA detection a critical requirement for clinical-grade adenoviral vector production and regulatory submission.
Figure 1. Overview of the Adenovirus replication cycle. (Giménez-Roig J, et al. 2021)
Creative Biogene provides a multi-layered RCA testing system combining traditional assays with advanced molecular methods. Our approach ensures compliance with FDA, ICH, and CPMP guidelines, delivering both safety and confidence in your viral preparations.
| Assay | Principle | Strengths |
| Cytopathic Effect (CPE) Assay | Adenoviral preparations are inoculated into permissive cell cultures. RCA is amplified and induces visible cell damage. | FDA-recommended gold standard; reliable across vector types. |
| Real-Time qPCR | Specific primers and probes detect E1 gene sequences associated with RCA. | High sensitivity and speed enable the quantitative assessment of RCA burden. |
| Orthogonal Confirmation | Integration of imaging and sequencing for ambiguous cases. | Ensures accuracy and eliminates false positives. |
We offer an end-to-end RCA testing workflow designed to streamline project execution while maintaining rigorous quality control:
1Sample Receipt & Assessment: Verification of adenoviral vector integrity and preparation.
2CPE Assay Setup: Indicator cells are exposed to the vector to amplify potential RCA.
3qPCR Quantification: Sensitive detection of E1 DNA to confirm RCA presence and load.
4Data Analysis & Validation: Dual-method cross-check for reliable results.
5Final Report Delivery: Comprehensive documentation including assay data, QC validation, and expert recommendations.
Our RCA testing supports diverse programs across the biopharmaceutical pipeline:
Unlike routine screening labs, our specialized adenoviral QC platform integrates regulatory compliance with advanced molecular detection.
Accepted Sample Types:
Deliverables Include:
Replication-competent adenovirus testing is not just a regulatory requirement—it is a cornerstone of patient safety and successful clinical translation. Creative Biogene combines experience, sensitivity, and compliance to deliver trusted RCA detection solutions. Contact us today to request a quote or schedule RCA testing for your adenoviral vector project.
Q: Why is RCA testing essential for adenoviral vectors?
A: RCA poses safety and regulatory risks. Sensitive testing ensures vector safety before preclinical and clinical use.
Q: Can Creative Biogene test GMP-grade samples?
A: Yes, our assays are fully compatible with GMP workflows and regulatory submissions.
Q: How sensitive is the qPCR method?
A: It detects RCA at very low copy numbers, ensuring early identification and intervention.
Q: What kind of report will I receive?
A: A detailed QC package including CPE observations, qPCR results, sequencing data, and expert interpretation.
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