Bio-Rad launches Vericheck ddPCR Replication Competent Lentivirus and Replication Competent AAV Kits for cell and gene therapy production

Adeno-associated virus (AAV) is commonly used as a viral vector in cell and gene therapy production, but there is a risk of it becoming a replication competent virus (RCV) during the production process, especially in the presence of a helper virus, which can raise safety concerns. While the guidelines recommend a cell culture–based method for RCAAV testing, it is cumbersome and takes 30–45 days from sample to results. Vericheck ddPCR™ RCAAV Kit is a fast, cost-effective, specific, and fully validated solution for AAV testing. Features and benefits Fast turnaround time:  Results in as little as 8 hours High sensitivity:  LOD of 0.50 copies/µl for RCAAV High specificity: 99.9% Novel assay design: Kit validated to be serotype agnostic (AAV1-AAV10) and offers low CV (<10%) for reproducible results Automated data analysis: Simplified workflow with positive controls included in the kit to aid automated results Comprehensive ddPCR workflow:  Supports and provides flexibility to run multiple samples per run

Lentiviruses are commonly used as viral vectors in cell and gene therapy production, delivering and steadily integrating desired genes into the genome of the host cell. However, they may also present health hazards to humans due to integration-mediated transformation and the creation of a RCL that can infect nontarget cells. While the current regulatory guidelines recommend a cell culture–based method for RCL testing, it is cumbersome and takes 30–45 days from sample to results. Bio-Rad’s Vericheck ddPCR™ RCL Kit is fast, cost-effective, specific, and a fully validated solution for lentivirus testing. Features and benefits Fast turnaround time: Results in as little as 8 hours High sensitivity: LOD of 0.35 copies/µl Reproducible results: Low CV of <10% between lots, users, plates and instruments Automated data analysis: Simplified workflow with positive controls included in the kit to aid automated results Comprehensive ddPCR workflow: Supports and provides flexibility to run multiple samples per run

Droplet Digital PCR System, includes droplet generator, droplet reader, laptop computer, software, associated component consumables, for EvaGreen or probe-based digital PCR applications