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PCR in Cell & Gene Therapy

Precisely measure clinical endpoints in your cell and gene therapy programs with PCR

Real-time quantitative PCR (qPCR) and droplet digital PCR (ddPCR) are essential tools throughout the development and manufacturing of cell and gene therapies (CGTx).

In the development of viral vectors and plasmid DNA for gene therapy, ddPCR offers precise quantification of target DNA molecules across various analytical assays necessary for viral vector production and characterization. For cell therapies, PCR can measure important endpoints including for CAR T cell therapy development.

  • Measure important clinical endpoints in your cell and gene therapy programs with PCR

    For gene and cell therapy development, Precision uses the Bio-Rad QX200™ ddPCR™ System, as well as a range of qPCR platforms and established technologies for PCR assays. Our precise and highly sensitive systems are scalable to accommodate high-throughput analyses, both at the preclinical stage and for clinical sample analysis.

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    For Gene Therapies

    • Biodistribution: Track vector localization and persistence in tissues post-administration
    • Transgene Expression: Assess distribution, level, and persistence of transgene expression
    • Copy Number: Determine the number of inserted transgene sequences in samples
    • Production of Viral Vectors and Plasmid DNA: Quantify target DNA molecules across various analytical assays necessary for viral vector production and characterization
    • Viral shedding: Measure release of virus- or bacteria-based gene therapy (VBGT) products from a patient through various sample types
    • Gene editing event detection
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    For Cell Therapies

    • Characterization: Fully characterize modified cells, including determining the copy number of inserted genes using PCR
    • Residual Lentivirus Detection: Use PCR to detect any residual lentivirus in the final drug product
    • Pharmacokinetics: Distribution, expansion, contraction, and persistence.
      • CAR-T biodistribution
      • Cell therapy persistence
    • CAR vector deliver efficiency via vector copy number measurement

Explore our holistic approach to delivering cell and gene therapies

Few solution providers for cell and gene therapies can offer the pioneering expertise of Precision. Fewer still have integrated the specialized capabilities that can help compress timelines and find efficiencies throughout a development process that will almost certainly encounter scientific and logistical complexities.

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    Clinical Trial Development

    From pre-clinical through registration studies, our experts are leaders in the advancement of cell and gene therapy development, leveraging the research interests of the sites to build clinical enthusiasm, supporting the logistical complexities of these trials, and addressing complex safety issues.

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    Specialty Lab Services

    Cell and gene therapy research requires specialized expertise to support successful translation from the bench to the clinic. We deliver, with a broad array of both established and Precision-engineered platforms targeted specifically to the needs of cell or gene therapy development, and thought leaders who are helping shape the therapeutic and regulatory landscape.

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    Manufacturing Solutions

    You’ll start with the team that led the industrialization of the most notable FDA-approved advanced therapies—and built the world’s largest cell and gene therapy manufacturing footprint. We help cell and gene therapy trials achieve operational excellence, accelerating speed to market for life-changing therapies.

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    Companion Diagnostics

    The success of your cell or gene therapy ultimately relies on accurate identification of appropriate candidates for treatment. These treatments often require a Companion Diagnostic (CDx). Precision has the required specialized clinical development, biomarker assay, regulatory strategy and commercialization capabilities.

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Globally recognized contract research organization in biomarker-driven development

When you work with Precision you not only gain access to our proprietary technologies,  you work directly with the innovators who developed these technologies—scientists who know how to build creative solutions to overcome complex developmental and clinical study challenges.

And while able to execute individual assays as needed, we specialize in holistic solutions that take into account the entirety of a clinical development project, especially for projects where we are working in conjunction with our clinical trials, regulatory, and data science teams for the integrated delivery of solutions for all aspects of a clinical development program.