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Testing for replication competent AAV and lentivirus is a critical component of gene therapy best practices. Orthogonal testing kits provide researchers with a faster, quantitative option for superior quality control.

Cell and gene therapy holds tremendous potential for treating a wide range of diseases and disorders. Researchers routinely use viral vectors to shuttle and integrate genes of interest into cell genomes, among which the most frequently used are lentivirus and adeno-associated virus (AAV) vectors.1 Even though these viral vectors are designed not to replicate, researchers must nevertheless adhere to fundamental safety and quality control considerations to minimize the risk of exposure and adverse events if viral particles inadvertently infect cells and begin replicating after administration. As a result, cell and gene therapy researchers must routinely test for replication competent virus (RCV) according to well-established regulatory authority requirements.2

The most common method for evaluating replication competency of lentivirus and AAV vectors is through serial passaging of virus in cell culture lines and subsequent identification of viral particles in the supernatant using molecular assays. While considered tried and true, this approach is labor and resource intensive and can take over a month to complete. As a result, researchers face significant turnaround time challenges that create bottlenecks and impede workflows.

Researchers engaged in cell and gene therapy research and development seek novel, robust, and highly sensitive technologies as alternatives to traditional RCV testing protocols. For example, Bio-Rad’s Vericheck ddPCRTM replication competent lentivirus and AAV kits provide a quantitative, highly specific, cost-effective, validated, and rapid solution for routine RCV evaluation. With the ability to cut testing time down to under eight hours and produce results that are 99.9% specific, this approach allows cell and gene therapy researchers to meet rigorous regulatory requirements and take quality control due diligence to the next level.

Learn more about replication competent lentivirus and AAV testing.

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