ddPCR

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

Although vaccines have helped alleviate the negative impact of COVID-19, its persistence across many areas of the globe reveals a continuous need for rapid, accurate, and economical COVID-19 testing. But is it even possible to isolate and detect viral RNA rapidly and economically? Here we highlight a repurposed tool for improved COVID-19 detection: Chelex 100 Resin and the related InstaGene Matrix for rapid, cost-effective viral RNA preservation and detection.

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.

Research into human diseases has led to the development of novel monoclonal antibody drugs. These monoclonal antibody therapies have been successful because of their specificity and selectivity. However, ongoing development and successfully launching a new mAb drug require robust and reliable methods to screen for drug targets, demonstrate drug safety and efficacy, and scale up manufacturing to meet the stringent regulatory guidelines required for approval.

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.

Developing adeno-associated virus (AAV)-mediated gene therapies requires accurate and precise quality control. Read how Droplet Digital PCR technology provides the sensitivity needed to assess the potential safety and effectiveness of these treatments.

The COVID-19 pandemic has captured the attention of the world and won’t let go. And that has sparked efforts for creative solutions in some surprising places. Wastewater is not where most peoples’ minds go first when they think of airborne diseases, but it holds much promise for tracing and predicting SARS-CoV-2 outbreaks.

Adeno-associated viruses (AAVs) are some of the most commonly used viral vectors for gene therapy, supporting approximately 250 clinical trials to date. However, the manufacturing processes are challenging to scale. Read about five key issues that gene therapy manufacturers who use AAVs need to look out for.