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Recombinant adeno-associated virus (rAAV) has emerged as a leading vector for gene therapy due to its simple structure, non-pathogenicity, site-specific integration, and low immunogenicity in somatic cells. Naturally, AAV is replication-defective and requires helper viruses (such as adenovirus or herpesvirus) to replicate. By removing the rep and cap genes and inserting the therapeutic gene between inverted terminal repeats (ITRs), recombinant AAV vectors are generated. These vectors efficiently transduce cells and tissues—including lung, brain, muscle, retina, CNS, and liver—and can maintain long-term expression in slowly dividing cells.
During production, however, homologous or non-homologous recombination events can give rise to rcAAV. Although rare, rcAAV poses potential safety risks, including uncontrolled replication in the presence of helper viruses, host genome integration, immune activation, or altered gene expression. Regulatory guidelines emphasize that clinical-grade rAAV products must demonstrate the absence—or controlled minimal presence—of rcAAV.
Creative Biogene offers a high-sensitivity, reliable, and fully traceable rcAAV Testing Service, providing essential support for rAAV research, development, and production. By combining cell-based amplification, quantitative PCR, virology assays, and customized reporting, we help clients implement a robust quality control barrier for rAAV vector safety.
Creative Biogene's rcAAV testing combines cell-based amplification with qPCR/ddPCR quantification to ensure highly sensitive and reliable detection. Candidate rAAV samples are introduced into target cells with a helper virus to induce potential rcAAV replication, followed by multiple rounds of passaging to amplify any replication-competent viruses.
Extracted viral DNA is then analyzed for rep and cap sequences, with results benchmarked against controls to determine the detection limit, reaching sensitivities as low as ≤1 rcAAV per 10⁶ vector genomes. Clients receive a detailed report including the testing strategy, amplification data, quantitative results, conclusions, and recommendations, with optional ddPCR assays available for ultra-sensitive or high-throughput applications.
Figure 1. Schematic describing the finalized rcAAV assay workflow. (Shevade A, et al., 2025)
1Project Initiation & Sample Submission: Clients provide rAAV samples (raw, intermediate, or final product) along with background information such as serotype, packaging system, and transfection/production strategy.
2Method Planning & Quotation: Our technical team designs a testing plan tailored to sample type, required sensitivity, and throughput, providing a detailed quotation.
3Sample Testing & Amplification: Cell amplification experiments and serial passaging are performed, followed by qPCR/ddPCR detection.
4Data Analysis & Report Generation: A report is prepared including LOD, positive/negative controls, sample values, analysis, and recommendations.
5Delivery & Post-Test Support: Electronic reports and raw data are provided as needed, with technical consultation for optimization or follow-up studies.
If you are developing or manufacturing rAAV vectors and require rcAAV safety control, contact Creative Biogene for a free project evaluation, testing plan consultation, and preliminary quotation.
Please provide the following to get started quickly:
Partner with Creative Biogene to ensure rAAV products are safe, reliable, and compliant—accelerating gene therapy development with confidence.
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