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

Bio-Rad

Validated detection of viral replication genes using Droplet Digital™ PCR during cell and gene therapy production

4 Mar 2024
Will Thompson
Editorial Assistant

Product news

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Bio-Rad Laboratories, Inc., a global leader in life science research and clinical diagnostics products, has launched the Vericheck ddPCR™ Replication Competent Lentivirus Kit and the Vericheck ddPCR™ Replication Competent AAV Kit. The kits provide rapid, cost-effective solutions for the absolute quantification of replication competent lentivirus (RCL) and replication competent adeno-associated virus (RCAAV), supporting the safe and effective production of cell and gene therapies.

Replication competent viruses (RCVs) can infect cells and replicate to produce additional virions. RCVs can be generated through recombination events between the transfer plasmid and either the production plasmids or the packaging cell line's genome. Fundamental to the safety of emerging cell and gene therapies, RCV testing of samples must be performed throughout the production process.

Bio-Rad’s Vericheck ddPCR kits for detection of RCL and RCAAV provide a validated solution for highly specific and highly sensitive detection and quantification of viral replication genes, potentially indicating an RCV. The tests are designed for Bio-Rad's QX Droplet Digital™ PCR (ddPCR™) platforms, with a simple workflow including automated data analysis and flexible sample throughput. Compared to traditional cell culture–based methods for RCV testing, the kits significantly reduce cost and turnaround time, achieving results in as little as eight hours.

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Vericheck ddPCR Replication Competent AAV Kit

Bio-Rad

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

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Vericheck ddPCR Replication Competent Lentivirus Kit

Bio-Rad

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

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QX200™ Droplet Digital PCR System

Bio-Rad

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

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Genome AnalysisGenomics, the study of genomes, includes functional genomics, evolutionary genomics and comparative genomics. There are many genomic technologies such as DNA sequencing of whole genomes, computational biology and bioinformatics. DNA and nucleic acids must be isolated and concentrated from cells for analysis with kits, automated analyzers and software. Other useful technologies for studying genomics include PCR, microarrays and electrophoresis.Cell Lines Stem Cells and Primary CellsPrimary cell cultures, established cell lines and stem cells are vital for <i>in vitro</i> and <i>ex vivo</i> experimentation. High-quality cells, optimized for your applications, alongside optimized cell substrates, growth medium and supplements, are critical for experimental success. Explore a range of cells suitable for your applications, including isogenic cell lines, competent cells, induced pluripotent stem cell (iPSC)-derived cell lines, fungal/bacterial/mammalian cell lines, stem cells and cancer cell lines. Find the best cells for your research in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Data AnalysisData analysis hardware and software is available to make data processing straight-forward yet powerful. Data software can be used for math and stats, technical graphing and image analysis. In addition, software is available for specific data analysis of electrophoresis, densitometry, ELISA and DNA sequencing.Labware and Lab SuppliesLabware and lab supplies include various forms of glassware, plasticware, reagents and personal protective equipment (PPE) and are used across all scientific laboratories, enabling daily tasks to be performed. Explore a range of flasks and beakers, petri dishes, carboys and storage bottles. Labware such as condensers, desiccators and burettes are also available for more specific tasks. Find the best labware and lab supplies in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Cell-Based AssaysCell-based assays are used to monitor the presence, quantity and activities of a desired cellular analyte including drug molecules or biomarkers. This can reveal information on cell health (apoptosis, cytotoxicity, viability and proliferation assays), cell metabolism, cell migration and cell signaling mechanisms. Find the best cell-based assay products, kits and equipment with our peer reviewed product directory: compare products, check customer reviews and receiving pricing direct from manufacturers.Gene Expression and Molecular CloningMolecular cloning is a set of techniques that utilizes vectors to transfer recombinant DNA into host cells and is an essential tool for investigating the expression of genes and proteins in bacterial or mammalian cells. A variety of vectors optimized for gene cloning and expression in a range of host organisms are available, alongside competent cells for genetic replication. Here, you can explore a range of molecular tools, high-quality genomic and cDNA libraries, premade clones, transformation and transfection reagents and mutagenesis or gene expression detection assays and expression arrays. Find the best gene expression and molecular cloning products in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Cell TherapyCell therapy involves using living cells to treat diseases, often by replacing damaged cells or stimulating regeneration. Stem cell therapy and CAR-T cell therapy are examples of cutting-edge treatments in regenerative medicine and cancer immunotherapy. Browse our peer-reviewed product directory to find the best cell therapy tools, compare products, check reviews, and get pricing directly from manufacturers.Data AnalysisThe analysis of data is the process of transforming, modeling and evaluating data to discover useful information from experimental results. Genome SequencingGenome sequencing involves determining the complete DNA sequence of an organism's genome. It provides crucial information about genetic variations, mutations, and diseases. Advances in sequencing technologies, such as next-generation sequencing (NGS), have accelerated research in genomics, diagnostics, and personalized medicine. Explore genome sequencing tools in our peer-reviewed product directory; compare products, check reviews, and get pricing directly from manufacturers.Gene TherapyGene therapy is a technique that modifies or replaces genes within an individual's cells to treat or prevent diseases. This approach holds potential for curing genetic disorders, cancers, and certain viral infections. Advances in gene editing technologies like CRISPR are driving the growth of gene therapy. Explore gene therapy tools and technologies in our peer-reviewed product directory; compare products, check reviews, and get pricing directly from manufacturers.

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