Droplet Digital PCR (ddPCR)

Inadequate quality control assays shouldn’t limit cell and gene therapy applications. Instead, quantifying the potency of cell and gene therapies is essential for successful therapeutics. In this article, we describe multiple leading potency assays developed using Droplet Digital PCR (ddPCR) technology, including an assay that quantifies transgene integration and expression in one step.

Gene editing is only useful if it’s successful. Read how scientists are leveraging the unparalleled accuracy and specificity of ddPCR technology to optimize quality control in gene editing projects, including HIV detection and CAR-T cell generation.

Two years into the COVID-19 pandemic, trends point to a transition for the SARS-CoV-2 virus into an endemic agent. As major surveillance infrastructure scales back, it will be critical to maintain a cost-effective, simple, and rapid strategy for detecting and monitoring the spread of new variants. The key to such a strategy? Wastewater, where all disease agents leave their unique signature.

Wastewater-based epidemiology indirectly monitors infection rates in a community based on pathogen levels in local wastewater. Because symptomatic and asymptomatic SARS-CoV-2 infected individuals shed viral RNA in sewer systems, analysis of SARS-CoV-2 in sewage networks can provide information about SARS-CoV-2 infections within the community. However, the accuracy of these data depends on the quality of the wastewater testing method. During the COVID-19 pandemic, Droplet Digital PCR has proven that it has the sensitivity needed to detect outbreaks and monitor SARS-CoV-2 variants in communities via wastewater testing.

Bispecific antibodies (bsAbs) are an important addition to the immuno-oncology toolbox. Designed to recognize two distinct epitopes, bsAbs have enhanced binding, specificity, and efficacy compared to current monovalent antibody therapeutics, making them exciting candidates for more targeted cancer treatments. Learn about bsAbs and how our tools can help scientists with their research on therapeutic candidates.

The CAR T-cell manufacturing process involves high potential for variability. Learn how sensitive ddPCR assays can be used to ensure safety and efficacy.

As more of the cell and gene therapies revolutionizing healthcare are approved for use, innovator companies usually get the credit. But many therapies would never make it to market without the expertise and capabilities of contract development and manufacturing organizations (CDMOs) operating behind the scenes. Learn more about how CDMOs enable new cell and gene therapies to come to market, and how Droplet Digital PCR can help.

Precision diagnostics for cancer. COVID-19 surveillance in wastewater. Quality control of cell and gene therapies. These were just a few of the cutting-edge applications on display at the Droplet Digital PCR (ddPCR) World 2021 symposium. Recapping the event in 5 takeaways, moderator Francisco Bizouarn shares how international experts are leveraging ddPCR technology to solve today’s scientific and public health problems.

No patient who has survived cancer wants to hear that they’ve relapsed. But hearing it sooner rather than later can dramatically increase the chances of finding a successful, potentially life-saving treatment. Using next-generation sequencing and Droplet Digital PCR, researchers at the University of Uppsala aim to detect relapse by monitoring patient-specific biomarkers. Read about their ongoing clinical study.

While the FDA has approved Abecma, the first CAR-T cell therapy in its class, regulatory approval is just the beginning for cell and gene therapies. Such therapies’ safety and financial viability rest on a robust manufacturing and quality control program with the flexibility to scale up and out. Droplet Digital PCR is a sensitive biopharmaceutical quality control tool, offering absolute quantification of nucleic acids and other molecules in a sample.